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Coronavirus: A timeline of how the deadly COVID-19 outbreak is evolving

10:33 am

Coronavirus company news summary – Roche unveils test kits to detect Omicron variant of SARS-CoV-2 virus – US plans to provide reimbursement for at-home Covid-19 tests

Roche and its unit TIB Molbiol have introduced three Research Use Only (RUO) test kits to identify the mutations in the novel B.1.1.529 Omicron variant of the SARS-CoV-2 virus. Intended for usage on LightCycler and cobas z 480 analysers, the VirSNip SARS Spike ins214EPE, VirSNiP SARS-CoV-2 Spike S371L S373P and VirSNip SARS Spike E484A test kits aid in distinguishing Omicron variant from other viral variants. Roche gained rights to the TIB Molbiol-developed test kits through its acquisition of the German firm earlier this month.

Eurofins Technologies has unveiled its multiplex RT-PCR assay, GSD NovaType Detect + Select K417N SARS-CoV-2 to detect the Omicron variant of concern. The test can qualitatively identify SARS-CoV-2 genomic RNA and the spike (S) mutation K417N concurrently. The test detects the Omicron variant even before the samples undergo complete genome sequencing and delivers results within one hour.

The US government has announced plans to completely reimburse at-home Covid tests for several Americans with private health insurance, Westport News reported. Individuals who are not covered under private insurance will receive free tests at over 20,000 government-supported testing centres in the country. It’s not clear when the fresh policy will be implemented with guidance anticipated on 15 January next year.

10:52 am

Coronavirus company news summary – Israel’s Nanox launches pilot to streamline diagnosis of Covid pneumonia – Thermo Fisher and Color Health expand Covid-19 testing solution in Texas

Israeli firm Nanox has launched a pilot programme with Shamir Medical Center in Tzifrin to expedite diagnosis of Covid-19 pneumonia using an advanced-imaging system. According to a report in The Jerusalem Post, the Nanox.ARC advanced-imaging system is described as ‘the new digital X-ray technology’ that enables the development of 3-D digital imaging results to support a detailed diagnosis. The device will also enable artificial intelligence (AI) use for remote diagnosis. 

Thermo Fisher Scientific and health technology company Color Health have announced a significant expansion of the K-12 ReadyCheckGo Covid-19 testing solution in Texas. The expansion makes the programme available in all school districts of the US state. The programme was formed in collaboration with the Texas Department of State Health Services. Currently, 32 districts are working to adopt the ReadyCheckGo testing solution. Several school districts in Ohio, North Carolina and Wisconsin are also using the solution. 

Infinity BiologiX has confirmed that its rRT-PCR assay, which targets three areas of the viral genome, can detect the Omicron variant of Covid-19. The company used the rRT-PCR test for testing more than nine million samples for Covid-19 since May 2021. Infinity BiologiX is also working with the Centers for Disease Control and Prevention (CDC) in the US to sequence the SARS-CoV-2 genome from positive samples. The programme is now extended after the emergence of the new variant.

11:24 am

Coronavirus company news summary – Vitiprints to supply 60 million Viracide Masks to South Africa – study finds that blood test can help predict Covid-19 severity

Vitiprints has secured a contract from Uvukile Medical and Surgical Supplies to deliver 60 million Viracide Masks to South Africa. These South African Health Products Regulatory Authority (SAHPRA)-approved masks have an antiviral and antibacterial coating designed to deactivate Covid-19 upon contact. According to the company, the coating is capable of deactivating 99.97% of SARS-CoV-2 and 99% of Human Coronavirus (229E) in under one minute of contact thereby reducing transmission of the disease.

US-based molecular diagnostics company Cepheid has said that its PCRplus-based Xpert coronavirus tests are expected to detect the new Covid-19 variant Omicron. An in-silico (computer-based) analysis found that the company’s Xpert Xpress SARS-CoV-2, Xpert Xpress SARS-CoV-2/Flu/RSV, and Xpert Xpress CoV-2/Flu/RSV plus tests are apparently unaffected by the Omicron variant. The tests are designed to target multiple genes to ensure accurate virus detection.

A team of researchers at Nagourney Cancer Institute in the US and Metabolomycs, INC have announced that a metabolism-based blood test at the time of diagnosis can help in predicting Covid-19 related illness severity and fatality risks. The findings are based on a study that included 82 patients with RT-PCR confirmed Covid-19. The blood samples obtained from these patients were assessed for biochemical composition using quantitative mass spectrometry to quantify metabolites. According to the investigators, these metabolic signatures can help in determining the severity of Covid-19 infection.

10:16 am

Coronavirus company news summary – DiaCarta develops Covid-19 test to detect new variant – Rheonix confirms its Covid-19 test detects Omicron Variant

US-based molecular diagnostics company DiaCarta has developed a new test to detect the new emerging Covid-19 variant, Omicron. The new multiplex qPCR-based test named QuantiVirus SARS-CoV-2 Variant Detection is based on DiaCarta’s proprietary XNA technology. It is designed to identify the SARS-CoV-2 virus and then distinguish various mutating variants. The company has secured CE/IVD marking and will commercialise this test globally.

Rheonix has confirmed that its Covid-19 MDx Assay is capable of detecting the emerging Omicron variant. The company said that the RT-PCR assay can also identify other SARS-CoV-2 variants of concern. The Rheonix Covid-19 MDx Assay is designed for the qualitative detection of nucleic acid from SARS-CoV-2 using saliva samples. The test is yet to be approved by the US Food and Drug Administration (FDA). However, the FDA has granted the test emergency use authorization (EUA) for use by authorised laboratories. 

Health technology company Detect has said that its PCR-quality, at-home rapid Covid-19 Test recognises the Covid-19 Omicron variant. The company made the announcement following a comprehensive bioinformatics analysis. The test is said to offer results in less than one hour. Recently, Detect’s Covid-19 Test was selected for the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics Initiative (RADxSM) to increase production.

9:42 am

Coronavirus company news summary – Thermo Fisher confirms TaqPath Covid-19 tests detect Omicron variant – Hologic’s SARS-CoV-2 tests effective for Omicron detection

Thermo Fisher Scientific has reported that its polymerase chain reaction (PCR) Covid-19 tests are capable of detecting the Omicron variant of SARS-CoV-2. The TaqPath COVID-19 Combo Kit and TaqPath COVID-19 CE-IVD RT-PCR Kit can detect the presence of three gene targets from the orf1a/b, S, and N regions of the virus to identify the infection. The Omicron variant impacts the S gene target while the orf1a/b and N gene targets in these tests are unaffected by this mutation. In addition, Thermo Fisher’s TaqPath COVID-19 2.0 tests can detect the virus even with variants while the company is also developing specific genotyping assays for Omicron detection. 

Hologic has reported that all three of its Covid-19 tests can identify the Omicron variant of the SARS-CoV-2 virus. No new mutations were found within regions of the genome targeted by the company’s Aptima SARS-CoV-2 Assay, Aptima SARS-CoV-2/Flu Assay or Panther Fusion SARS-CoV-2 Assay on evaluating genetic sequences from over 175 Omicron-infected specimens. Furthermore, data from clinical users in Europe showed that the Aptima SARS-CoV-2 Assay could detect Omicron-caused infections in specimens collected from inbound flight passengers.

PerkinElmer has announced that the performance of its Covid-19 reverse transcription-polymerase chain reaction (RT-PCR) tests was unaffected by Omicron, a SARS-CoV-2 variant of concern. As the company’s assays do not rely on the S gene for Covid-19 detection, they are not impacted by the S gene mutations present in Omicron. The Covid-19 portfolio of PerkinElmer comprises high throughput ribonucleic acid extraction, RT-PCR kits, sequencing workflows to identify mutations as well as a broad immunodiagnostics portfolio.

9:42 am

Coronavirus company news summary – Eurofins introduces RT-PCR kits to detect B.1.1.529 variant – Novacyt’s Covid-19 test obtains approval in UK under CTDA

Eurofins Technologies has launched GSD NovaType Select kit to enable rapid detection of the emerging SARS-CoV-2 variant B.1.1.529 variant. Offered through Gold Standard Diagnostics Europe, the kit comprises a set of RT-PCR assays to identify mutations in the SARS-CoV-2 genome in around one hour. GSD NovaType Select P681H can distinguish between B.1.1.529 variant from the Delta variant. Furthermore, all positive samples for the P681H mutation should be processed using GSD NovaType Select T478K as well as K417N to further distinguish B.1.1.529 from other variants of concern.

Novacyt has reported that its genesig Covid-19 Real-Time PCR test obtained approval in the UK under the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (CTDA) of the UK Health Security Agency. Introduced on 31 January last year, the genesig COVID-19 assay is one of the first commercially available Covid-19 tests. It targets the ORF1ab gene and can potentially detect all known variants as well as SARS-Cov2 mutations. So far, the test has assessed more than 4.5 million sequences.

 QuantuMDx has reported that its Covid-19 tests are capable of detecting all known SARS-CoV-2 virus strains, including the new variant B.1.1.529. The company said that its assays for open polymerase chain reaction (PCR) platforms; rapid PCR device Q-POC; and its upcoming respiratory panel can identify the new variant. Q-POC can be deployed in various settings including hospitals, pharmacies, clinics and workplaces. The device and its first test, a SARS-CoV-2 detection assay, have received CE-IVD marked for usage within Europe.

10:34 am

Coronavirus company news summary – New Zealand reaserchers find rapid Covid-19 antigen testing misses 44.3% of positive cases – NMC Healthcare opens drive-through Covid-19 testing hub in Abu Dhabi

New Zealand researchers have found that the rapid antigen tests (RAT) for Covid-19 detection could potentially miss up to 44.3% of infections, Newshub reported. The scientists compared results obtained from five RATs and three Nucleic Acid Amplification Tests (NAATs) with those with standard polymerase chain reaction (PCR) tests. The study also found that rapid NAATS were more sensitive compared to RATs. Earlier, the government decided to repeal a ban on point-of-care RATs, thereby aiding companies to procure RATS for testing their employees from next month. 

NMC Healthcare has opened a drive-through Covid-19 testing centre at Oxford Medical Centre in Abu Dhabi of the UAE to offer reverse transcription-polymerase chain reaction (RT-PCR) tests seven days a week, Khaleej Times reported. The facility was inaugurated by NMC Healthcare CEO Michael Davis and president of operations Clancey Po. NMC currently has such facilities at NMC Speciality Hospital on Electra Street, NMC Royal Medical Centres at Karama and Shahama Bareen International Hospital in Mohamed Bin Zayed City and NMC Royal Hospital Khalifa City.

Gravity Diagnostics, a lab in Northern Kentucky, US, has processed over three million Covid-19 tests for the Tri-State so far, and anticipates the demand to increase in the holiday season. The lab can process over 1,000 tests in a couple of hours. Ohio Department of Health Director Dr Bruce Vanderhoff advised people to test themselves following holiday gatherings, especially those who are yet to receive the Covid-19 booster vaccine.

12:20 pm

Coronavirus company news summary – New Zealand unveils novel Covid-19 testing strategy – Indian firm Agappe to introduce Covid-19 test kit

New Zealand’s government has launched a novel testing strategy under its Covid-19 protection framework to offer improved protection for the population at increased risk. The country will invest approximately $1bn in Covid-19 testing, contact tracing and case investigation to cut down disease spread. Nasopharyngeal polymerase chain reaction (PCR) tests will remain the primary diagnostic method while saliva-based PCR tests, rapid antigen tests and rapid PCR tests will also be offered. From next month, companies will be able to directly procure approved rapid Covid-19 antigen tests for their employees.

Indian company Agappe Diagnostics is set to introduce its Covid-19 confirmatory test solution, AG InstaLume Reagent Kit, which does not require ribonucleic acid (RNA) extraction process and delivers results in 30 to 35 minutes of collecting the specimen. Leveraging the real-time LAMP (RT-LAMP) platform, the test is said to have sensitivity of over 98.7% and specificity of 100%. To carry out the test, nasopharyngeal swab samples obtained from the user are mixed in the lyse buffer and processed using the test kit. The reaction vial can be directly loaded in RT-LAMP Analyzer, MISPA LUME, thereby lowering the sample to report turnaround time to 35 minutes with greater precision.

Achiko has provided updates on its rapid Covid-19 diagnostic test AptameX. The firm reported ‘substantial progress’ in the marketing of AptameX along with its digital passporting service, Teman Sehat (Health Buddy). Reduced-cost, miniature aptamer-based tests are said to be advantageous over antigen-based tests as they are easy to modify and immobilise, and have increased target affinity and specificity. The company also noted that its pilot programme is underway in Bali and regions near Jakarta. Achiko has sought approval for the product from Indonesia’s Ministry of Health, with the initial manufacturing of the AptameX test kit underway in the region. Filing to obtain a CE mark of the test is expected in the first quarter of next year.

11:15 am

Coronavirus company news summary – WHO and MPP sign deal with CSIC for Covid-19 antibody technology – South Korea’s Seegene to introduce new diagnostic tests 

The World Health Organization (WHO)’s Covid-19 Technology Access Pool (C-TAP) and the Medicines Patent Pool (MPP) have signed a licencing agreement for Spanish National Research Council’s (CSIC) Covid-19 serological antibody technology. The technology helps identify the presence of anti-SARS-CoV-2 antibodies developed either in response to a COVID-19 infection or to a vaccine. The agreement is expected to expedite the production and commercialisation of CSIC’s Covid-19 serological test worldwide and marks the first transparent, global, non-exclusive licence for a COVID-19 health tool, and the first test licence signed by MPP and included in the WHO Pool.

South Korean molecular diagnostics firm Seegene has announced it will introduce diagnostic tests in a move to better prepare for a potential increase in Covid-19 and influenza cases during the winter. The tests will be capable of identifying 22 targets including three Covid-19 genes in a single tube. This was announced alongside Seegene’s results for the third quarter of this year. The company reported sales revenue of KRW305.3bn ($260m) in the three-month period to 30 September 2021. The figure represents a 1% increase on a QoQ basis.

Vivera has introduced an AI software solution called LabPort to streamline the Covid-19 diagnostic testing process. The solution was created to enable immediate results reporting for diagnostic testing even in high-volume, field-based testing environments. It was first deployed in July 2021 and has been used to manage the testing process for more than 60,000 EUA-authorised rapid antigen and lab-based RT-PCR tests for major events.

10:52 am

Coronavirus company news summary – Vitiprints announces launch of the Viracide Mask in Africa – Biocept launches test to distinguish between influenza and Covid-19

Vitiprints has announced the launch of Viracide Masks in Africa in a bid to prevent transmission of Covid-19. The mask was rolled out through a distribution partnership with Uvukile Medical and Surgical Supplies. According to the company, Viracide Masks have an antiviral and antibacterial coating capable of deactivating Covid-19 and its variants in under one minute of contact with the surface of the facemask. Initially, the mask will be available in South Africa and neighbouring countries, Lesotho and Swaziland.

Biocept has launched a single test that can distinguish between influenza and the Covid-19 causing virus, SARS-CoV-2 to help patients and caregivers determine appropriate treatment decisions. The combined Covid-19 and influenza test leverages a sensitive and specific reverse transcription-polymerase chain reaction (RT-PCR) platform to differentiate SARS-CoV-2 and influenza from a nasal swab. The results are typically delivered within 48 hours from receipt of the sample, the company said.  

Sorrento Therapeutics’ subsidiary in Mexico has signed a contract with a local firm for the sale and distribution of up to five million COVI-STIX Covid-19 rapid antigen detection tests in the country. According to the company website, COVI-STIX tests enable the detection of SARS-CoV-2 virus antigens directly from a nasal swab sample in 15-20 minutes. The tests were commercially launched in July and are suitable for mass screening during social gatherings, sports events and school attendance.

11:13 am

Coronavirus company news summary – Detect launches at-home ‘PCR-quality’ Covid-19 test – UK begins review on ethnic bias in devices and impact on Covid-19

Detect, a US-based health technology company, has released what it describes as a polymerase chain reaction (PCR)-quality, at-home rapid Covid-19 test. According to the company, the Detect Covid-19 Test is a molecular rapid test that identifies the SARS-CoV-2 virus at lower viral loads compared with antigen tests. This is expected to help in early detection of the disease. The test can be conducted at home in one hour and will be sold online through the company website from next month.

The UK Government has launched an independent review on potential ethnic bias in the design and use of some medical devices. The move comes following concerns that certain devices such as oximeters work better on people with lighter skin and exaggerate oxygen levels when used by ethnic minorities. The investigation aims to identify if such disparities have prevented patients from receiving appropriate Covid-19 treatment. Initial findings are expected by the end of January 2022.

Vela Diagnostics has announced that the ViroKey SARS-CoV-2 RT-PCR Test can be used with the Thermo Fisher’s KingFisher FLEX system and Hamilton Microlab STAR platforms. The test has already secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). According to the company, the test kit will run with the KingFisher FLEX to reduce turnaround time and boost sample throughput. Meanwhile, the Hamilton Microlab STAR option provides a throughput of 376 samples per run.

10:50 am

Coronavirus company news summary – AXIM praises FDA policy update on Covid-19 tests – Helix and Cue Health partner on SARS-CoV-2 variant sequencing

AXIM Biotechnologies has praised the US Food and Drug Administration (FDA) on its latest update to its policies on Covid-19 tests. The update aims to boost access to at-home and point-of-care tests across the country while ensuring the accuracy and reliability of such tests. The FDA will prioritise emergency use authorization applications for diagnostic tests that can be produced at large scale. This covers point-of-care and lab-based high-volume antibody tests that can assess total antibody levels or neutralising antibody levels. AXIM noted that the move supports the development of the company’s Covid-19 rapid neutralising antibody test.

Helix and Cue Health have partnered to offer SARS-CoV-2 variant sequencing information to people who have tested positive on the latter’s at-home molecular Covid-19 test. The partnership builds on Cue’s real-time Variant Tracking and Sequencing Platform, which will leverage artificial intelligence and machine learning from Google Cloud. The latest option is expected to be rolled out in the fourth quarter of this year. Helix’s variant sequencing is currently not yet authorised for use in healthcare by the US Food and Drug Administration, and the companies noted the information should not be used to inform medical decisions.

A Japanese pharmaceutical firm has made part payment of a $1.07m (JPY117.5m) order for Beroni Group’s SARS-CoV-2 Antigen Test Kit. Beroni has manufactured and supplied nearly two-thirds of the test kits under the contract with the company. Leveraging colloidal gold solid-phase immunochromatography, the CE-marked test can detect Covid-19 from nasopharyngeal swab samples and deliver results within ten minutes. The test was found to have an overall sensitivity and specificity of 95% and 100%, respectively.

12:44 pm

Coronavirus company news summary – Michigan faces Covid-19 test kit shortage – US researchers develop false-positive detection system

The US state of Michigan is facing a shortage of rapid Covid-19 tests as more businesses are testing their employees. The state is currently seeing an increase in the number of Covid-19 cases. As of 17 November, a total of 1,224,273 confirmed cases were reported in the state. The Michigan Department of Health and Human Services told News 10 that due to a shortage in supplies, the department is not presently supplying test kits to schools.

Researchers at the University of Missouri School of Medicine in the US have developed a method to detect possible false-positive Covid-19 results. This technique could be beneficial for asymptomatic people who are not exposed to the SARS-Cov-2 virus and aid in averting unnecessary quarantining and repeated testing. The reverse transcriptase-polymerase chain reaction (RT-PCR) test, a current golden standard for Covid-19 testing, is linked to the reduced number of false positives. Deploying a limited retesting approach could identify clinically relevant testing errors and aids labs in enhancing testing practices.

Microbix Biosystems has extended its portfolio of Quality Assessment Products (QAPs) to incorporate controls that back polymerase chain reaction (PCR) tests for four SARS-CoV-2 variants of concern (VOC). The in-vitro diagnostic quality controls can improve the PCR lab tests’ workflow accuracy for the Brazilian, Delta, South African and UK variants. Created using COPAN FLOQSwabs, the four VOCs are in addition to QAPs for the SARS-Cov-2 Wuhan strain.

11:37 am

Coronavirus company news summary – ChemBio seeks FDA approval for antigen test – US project to research Covid-19 correlate of protection

Chembio Diagnostics has submitted an application seeking Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its new DPP SARS-CoV-2 Antigen test. The system is intended to identify SARS-CoV-2 antigens from a minimally invasive nasal swab sample in 20 minutes. The test results can be interpreted visually on the system or using a DPP Micro Reader or DPP Micro Reader 2 optical analyser. In December 2020, the US Biomedical Advanced Research and Development Authority granted funding to Chembio to help develop a point-of-care antigen test system using its DPP technology.

AXIM Biotechnologies has collaborated with Arizona State University in the US to develop a Covid-19 ‘correlate of protection’ leveraging its neutralising antibody test. The collaborative study is intended to detect the threshold at which neutralising antibody levels have fallen to a point that they do not provide protection against infection. Neutralising antibody levels will be used as a correlate of protection. People at increased risk will be enrolled in the trial and their levels of neutralising antibodies will be assessed every week with the help of AXIM’s rapid test.

PacBio has introduced its HiFiViral SARS-CoV-2 Kit, an end-to-end system for genomic monitoring of the virus’s variants. Public health labs can use the kit to detect novel variants of SARS-CoV-2 and identify all the circulating variants. Using the company’s HiFi sequencing, the test provides a more comprehensive picture of new mutations, guaranteeing that emerging variants are detected, PacBio said. The kit can process up to 384 samples simultaneously.

10:07 am

Coronavirus company news summary – US health department withdraws Trump-era policy limiting review of Covid-19 lab tests

The US Department of Health and Human Services (HHS) has announced plans to withdraw a policy put in place by the previous administration that limited the authority of the US Food and Drug Administration (FDA) to review lab-developed Covid-19 tests. The policy announced in August last year determined that the FDA should not carry out premarket review, including premarket approval or 510(k) clearance and emergency use authorisation of laboratory-developed tests (LDTs), even when poor performance is reported. Prior to August 2020, laboratories had to file applications to create and use their Covid-19 tests, CNN reported.

US-based molecular diagnostic assay provider Biocept has recorded a 165% year-on-year rise in revenues to $17.5m in Q3 2021, driven by higher reverse transcription-polymerase chain reaction (RT-PCR) Covid-19 testing. For Q3 2021, RT-PCR Covid-19 tests alone generated revenue of $16.5m with over 660,000 samples tested since June last year. Testing volumes rose during the third quarter due to the emergence of the SARS-Cov-2 Delta variant, the company reported.

Cordant Health Solutions has collaborated with US-based incubator RAIN to offer Covid-19 testing for businesses, schools and other institutions. Cordant’s offering includes reverse transcription-polymerase chain reaction (RT-PCR) testing using saliva and nasal specimens collected from symptomatic and asymptomatic people at home or at a testing site and processed at the company’s Tacoma lab. The company had also introduced a low-cost RT-PCR pooled surveillance testing method for bigger groups. These two methods deliver results in 24 hours. Cordant’s over-the-counter rapid antigen and antibody tests for home or office usage provide results in 15 minutes.

12:29 pm

Coronavirus company news summary – Germany reinstates free Covid-19 testing as cases surge – Daewoong to supply diagnostic kits to Vietnam in $10.1m deal

Germany has reinstated free Covid-19 tests due to a surge of cases in the country. The free rapid Covid-19 antigen tests were offered initially from March and were halted last month, Reuters reported. The German government had decided to stop offering free tests from October this year to boost vaccination rates in the country, Deutsche Welle reported. Ministry of Health estimates show that over 67% of the people are currently fully inoculated.

South Korea-based Daewoong Pharmaceutical has entered a contract with Vietnamese firm Vietha Pharma to supply Covid-19 diagnostic kits worth nearly $10.1m in the country. In July, Daewoong signed a supply deal with the kit’s developer CALTH, a South Korean firm focusing on in-vitro diagnostic medical device development, Korea Biomedical Review reported. Leveraging an immunochromatographic approach, the kit can detect the SARS-CoV-2 virus from nasopharyngeal smear samples in 15 minutes. It has an accuracy of over 95% in detecting Covid-19. Based on the performance in Vietnam, Daewoong intends to extend the sales of the test kits across Southeast Asia.

12:42 pm

Coronavirus company news summary – Vivera to provide free Covid-19 testing to SoCal first responders – Irish Pharmacy Union warns of spiking demand for home Covid-19 tests in December

Vivera Pharmaceuticals is set to provide free Covid-19 testing services for all first responders and their families in Southern California, US, through its laboratory Pala Diagnostics. Los Angeles city employees, including first responders, who are not immunised with the Covid-19 vaccine are mandated to test themselves twice a week at a cost of $65 for each test, which is deducted from their salary, the company said.  Vivera also intends to open testing centres at several sites across Southern California to streamline and extend cost-effective Covid-19 testing.

The Irish Pharmacy Union (IPU) has said that pharmacies are witnessing a significant increase in sales of Covid-19 antigen tests for at-home use, with demand predicted to surge in the run-up to Christmas, The Irish Times reported. General practitioners have observed a trend of people considering negative results as confirmation for not contracting Covid-19 and ignoring crucial guidelines. There are concerns that the general population will increasingly abandon both polymerase chain reaction testing and other protocols on obtaining negative results with home tests. Issues around false-negative results have been raised with lateral flow tests.

The Government of Jersey has set up a new Covid-19 testing lab at General Hospital, which will start processing tests from 22 November this year, BBC reported. The move comes after the state terminated a deal with a firm, OpenCell, which ran a lab in a shipping container near to the island’s airport. Three new testing devices installed at the hospital will handle polymerase chain reaction (PCR) swab samples. The facility’s capacity will be expanded based on demand.

9:33 am

Coronavirus company news summary – FDA classifies Ellume test recall as Class 1 – GoMeyra partners with Alliance Health to boost US testing capacity

The US Food and Drug Administration (FDA) has classified the recall of Ellume’s Covid-19 test as Class 1, marking it as the most serious kind of recall. Last month, the company recalled some batches of its COVID-19 Home Test due to increased rates of false-positive test results. The FDA received 35 reports of false-positive results associated with the over-the-counter antigen test. In December last year, the test received Emergency Use Authorization from the FDA for use in individuals aged two years and above to detect Covid-19 using a nasal sample. To date, 2,212,335 tests have been recalled in the US.

GoMeyra has entered a collaboration with Alliance Health to boost its Covid-19 testing capabilities. Alliance Health, with facilities in New York and Florida, US, provides walk-in, mobile, drive-through and onsite testing services. Use of GoMeyra’s Laboratory Information Management Solution (LIMS) is intended to help Alliance Health handle more samples. LIMS is a cloud-based system that offers fast processing times for Covid-19 reverse transcription-polymerase chain reaction (RT-PCR), antibody, antigen, rapid PCR as well as serology testing, GoMeyra said.

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Meridian Bioscience’s Revogene SARS-CoV-2 assay. The test is intended to qualitatively identify the SARS-CoV-2 virus using nasopharyngeal, anterior nasal, oropharyngeal as well as mid-turbinate nasal swab samples. With a positive percent agreement and a negative percent agreement of 97.7%, the test can deliver a positive result in just 47 minutes. The company plans to commence shipping of the molecular diagnostic tests before the end of 2021.

10:26 am

Coronavirus company news summary – WHO warns of potential syringe shortage in 2022 – Denka recalls Covid-19 test kits in Japan over material defects

The World Health Organisation (WHO) has warned that the world could face a scarcity of one to two billion syringes required to administer the Covid-19 shot next year, Reuters reported. This shortage could affect routine vaccinations and compromise needle safety, the agency said. WHO group lead on supply and access to medicines Lisa Hedman told a UN briefing that national health agencies should plan their syringe requirements in advance to prevent hoarding and panic purchasing.

Japanese company Denka will recall 130,000 boxes of Covid-19 antigen rapid test kits supplied by the government to medical facilities and care home centres. The company issued a voluntary recall of QuickNavi – COVID19 Ag, produced at its factory in Niigata Prefecture in December 2020, following a material defect found in some kits, The Mainichi reported. This issue could lead to delivery of false positive results in individuals.

The US National Institutes of Health (NIH) has issued a $14.9m grant to Anavasi Diagnostics under the Rapid Acceleration of Diagnostics (RADx) initiative to expedite the launch and market availability of its new rapid molecular Covid-19 test. The AscencioDx molecular diagnostic platform can identify the ribonucleic acid indicative of the SARS-CoV-2 virus. The test can deliver results in line with polymerase chain reaction testing in under 30 minutes. Anavasi is currently analysing the test in clinical trials and intends to seek Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) soon.

11:41 am

Coronavirus company news summary – Sona and Arlington Scientific to partner on marketing rapid saliva Covid-19 test – Japan to offer free Covid-19 testing to asymptomatic citizens

Sona Nanotech has signed a binding licensing agreement with in-vitro diagnostics developer Arlington Scientific to market the former’s quick saliva Covid-19 test. Under the deal, Sona will license the intellectual property for its rapid saliva Covid-19 test to Arlington. Arlington will seek an Emergency Use Authorization from the US Food and Drug Administration for use in the point-of-care as well as at-home setting. Arlington can produce and supply the test in the US on obtaining approval. The test has demonstrated a sensitivity and specificity of 93% and 100%, respectively.

Japan has plans to offer free Covid-19 tests to people showing no symptoms of SARS-CoV-2 infection. This move is anticipated to help protect the country against a potential surge of Covid-19 cases. To date, Covid-19 tests are offered free to individuals having virus-associated symptoms and those exposed to infection. Testing centres will be chosen by prefectural governments. Covid-19 has claimed over 18,000 lives in the country.

Several mayors from both sides of the US-Canada border have urged the Canadian federal government to scrap the Covid-19 test mandate for fully vaccinated travellers, CBC reported. Following 19 months of closure, the US has now reopened the land border for fully inoculated tourists. Border-town mayors noted that vaccinated people who enter Canada are required to furnish negative results from an expensive molecular test.

11:12 am

Coronavirus company news summary – FDA clears iHealth Covid-19 lateral flow test for home use – German Medical Association president calls for return of free Covid-19 testing

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the over-the-counter sale of iHealth Labs’ Covid-19 Antigen Rapid Test. The lateral flow assay can qualitatively identify the nucleocapsid protein antigen from the SARS-CoV-2 virus. Indicated for those aged two years and above who are symptomatic or as a serial test for asymptomatic people, the at-home self-test offers results in 15 minutes. iHealth can currently manufacture 100 million tests monthly and anticipates boosting capacity to 200 million starting from January 2022.

German Medical Association president Klaus Reinhardt has urged Germany’s federal and state authorities to quickly reinstate free Covid-19 testing as the country is witnessing a surge in cases, Deutsche Welle reported. To get more people vaccinated, free Covid-19 tests were phased out in October. According to Reinhardt, this strategy is not working, and he has urged a stringent requirement to allow only those vaccinated or recovered from Covid-19 to attend events or enter public places.

Scientists at the University of California San Diego in the US have developed a quick diagnostic technology that can identify the SARS-CoV-2 virus. Leveraging CRISPR gene-editing technology, the novel sensitive enzymatic nucleic acid sequence reporter (SENSR) permits quick identification of pathogens by recognising the genetic sequences in their DNA and RNA. The team noted that SENSR can potentially streamline the Covid-19 detection process and could be modified for usage in the at-home setting. SENSR demonstrated an ability to identify the SARS-CoV-2 virus in under one hour in previous tests.

10:42 am

Coronavirus company news summary – FDA expands EUA for GenBody’s Covid-19 antigen test – TESTD’s Covid solution meets US OSHA mandate

The US Food and Drug Administration (FDA) has granted an amendment to GenBody’s Emergency Use Authorization (EUA) for its Covid-19 antigen test kit to include the usage of anterior nasal swabs. The visually readable, point of care test qualitatively identifies the nucleocapsid protein antigen from the SARS-CoV-2 virus. GenBody supplies direct nasopharyngeal and anterior nasal swab antigen tests that can be utilised for Covid-19 testing in CLIA-certified labs. The company has also received a US National Institutes of Health (NIH) grant of $10m to boost the manufacturing of its tests in the country.

Co-Diagnostics‘ Logix Smart SARS-CoV-2 2-Gene multiplex test has secured approval for use and supply in the UK. The test has been validated under the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (CTDA) of the United Kingdom Health Security Agency (UKHSA). To be offered for supply through Clent Life Science, the company’s distributor in the country, the test is validated for usage with various kinds of samples, including saliva specimens.

Medical data management company TESTD has reported that its platform has met the requirements of the US Occupational Safety and Health Administration’s (OSHA) just-filed Emergency Temporary Standard (ETS) for Covid in one software solution. The TESTD platform automates the scheduling of medical tests and immunisation, handles medical data and consolidates it for straightforward reporting. Leveraging blockchain and various other technologies, the platform protects and encrypts all data, ensuring compliance with the new government requirements.

10:11 am

Coronavirus company news summary – Qiagen’s multiplex test obtains CE mark for Covid-19, flu and RSV detection – Avacta and Novacyt withdraw supply of some Covid-19 tests in the UK

Qiagen has obtained a CE mark for its QIAstat-Dx Respiratory 4 Plex Flu A-B/RSV/SARS-CoV-2 test, which is intended to be used on the QIAstat-Dx system. The newly launched polymerase chain reaction (PCR) multiplex test can rapidly detect and distinguish between influenza A and B, respiratory syncytial virus (RSV) and Covid-19 infections. Using the simple QIAstat-Dx modular cartridge-based system, the test provides rapid results in nearly one hour without needing further preparation of the sample.

Avacta and Novacyt have suspended the marketing of certain Covid-19 tests in the UK following the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 of the UK Health Security Agency coming into effect. Avacta has halted the sales of its AffiDX SARS-CoV-2 Lateral Flow Rapid Antigen Test in the country until the agency concludes the desktop evaluation. Novacyt will now only market its PROmate COVID-19 test while the authority reviews its other nine tests.

Semiconductor supplier Renesas Electronics has ramped up production of a synchronous boost converter solution used with Lucira Health’s at-home Covid-19 test, due to anticipated high demand. The single-use Lucira COVID-19 All-In-One Test Kit obtained Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) in November last year. It has a ‘swab, stir and detect’ design to deliver a positive or negative result in the at-home setting in just 30 minutes.

10:07 am

Coronavirus company news summary – FDA expands EUA of LumiraDx’s SARS-CoV-2 test for asymptomatic people – Cue Health offers molecular Covid-19 testing platform to MLB clubs

The US Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for the LumiraDx SARS-CoV-2 Antigen Test to incorporate testing of asymptomatic people. The test was formerly intended exclusively for use in people suspected to have Covid-19 by a healthcare professional within 12 days of symptom development. The EUA expansion is based on the latest data from asymptomatic individuals which showed the test had a positive and negative agreement of 82.1% and 100%, respectively, with an RT-PCR test.

The FDA has granted authorisation for pooled saliva sampling using the Yale School of Public Health SalivaDirect PCR COVID-19 test. Yale-approved labs can now utilise the test to pool up to five saliva samples at once for testing. The test is intended to be used for routine checking of asymptomatic people or for those suspected of having Covid-19. Adult users can obtain samples in the presence of a trained professional or in an at-home setting using the SalivaDirect Unsupervised Collection Kit or SalivaDirect At-Home Collection Kit.

Cue Health is offering its integrated Cue platform to all the Major League Baseball (MLB) clubs and the league office during the Postseason and World Series. The molecular diagnostic platform comprises the portable Cue Health Monitoring System and Cue COVID-19 tests. The platform can provide results straight to smartphones in just 20 minutes. It is the first-ever molecular diagnostic test to obtain FDA authorisation for use without needing the supervision of a doctor or a prescription.

10:20 am

Coronavirus company news summary – Prolacta creates test to identify SARS-CoV-2 in breast milk of donor – FDA grants EUA to iCare Diagnostics’ Covid-19 test

Prolacta Bioscience has created a nucleic acid amplification test (NAAT) that can identify the presence of various viruses, such as Covid-19, and bacteria in breast milk from a donor. As NAAT examines the milk directly for pathogens that cause infectious diseases, the company ensures that the donor and the milk are tested, reducing the possibility of contaminated milk reaching the neonatal intensive care unit.

Doyne Medical Clinic is providing Covid-19 tests that offer results within 15 minutes at Martin Luther King and Bonanza in Las Vegas, US. While the country is facing a scarcity of Covid-19 tests, Doyne states that the clinic is well-stocked. The company’s staff can provide Covid-19 testing on the spot or arrange for testing onsite for businesses, Nevada Business reports. According to a US Government’s employer mandate, companies with 100 or more staff need all workers to be either fully inoculated against Covid-19 or tested every week.

The US Food and Drug Administration (FDA) has awarded Emergency Use Authorization (EUA) to iCare Diagnostics International’s saliva-based Covid-19 test kit, the Taipei Times reported. Named iCare DX, the polymerase chain reaction (PCR) test is intended to identify the SARS-CoV-2 virus using saliva specimens. No medical specialist is required to obtain the saliva swab to carry out the test, making it easily deployable.

10:52 am

Coronavirus company news summary – BD and US Government partner to develop Covid-19 combination tests – OSW scientists develop breath test for Covid-19 detection

BD and the US Biomedical Advanced Research and Development Authority (BARDA) have entered a strategic, public-private partnership to develop various Covid-19 combination diagnostic tests. Initially, BARDA will provide $24.7m to BD with options to receive an additional grant of $40.3m to develop and obtain 510(k) clearance from the US Food and Drug Administration (FDA) for five novel combination tests. These tests will be used in core labs, hospitals and point of care locations.

Scientists at the Ohio State University (OSW) Wexner Medical Center are developing a breath test that can screen for the presence of Covid-19. According to the findings from the preliminary study, the breath test was found to be highly precise in detecting Covid-19 in critically ill patients. On getting infected with Covid-19, an atypical breath print is expected due to the interaction of oxygen, nitric oxide and ammonia in the body. The breath detector device can identify the Covid-19 breath print present in the exhaled breath in just 15 seconds.

Quidel has entered a multi-year collaboration with the American football team New York Jets to donate 10,000 Covid-19 tests to underserved communities via United Way of Northern New Jersey, a non-profit supporting vulnerable and disadvantaged communities. Quidel produces the QuickVue At-Home OTC Covid-19 Test. The company will become New York Jets’ official diagnostics partner and get substantial brand exposure to create awareness on the significance of Covid-19 testing.

10:36 am

Coronavirus company news summary – Fulgent introduces Covid-19 neutralising antibody test for at-home use – RADx Tech scientists progress studies of at-home rapid Covid-19 tests

The Aptima SARS-CoV-2/Flu Assay from Hologic is now available for commercial use in North America and Europe. The test can simultaneously identify SARS-CoV-2, influenza A and influenza B. The test runs on the company’s fully automated Panther system, which can conduct over 1,000 tests in 24 hours and delivers preliminary results in nearly three hours. The assay has obtained a CE-mark for diagnostic testing in Europe and is authorised for use in Canada and the US.

Fulgent Genetics has launched a neutralising antibody test for Covid-19 for use in at-home settings. Set to be offered through Fulgent’s consumer-initiated platform, Picture Genetics, the test will aid allow users to understand what their resistance might be to an active Covid-19 infection. The finger prick test can be conducted at home to assess the neutralising antibody levels in vaccinated individuals and people who have recently recovered from Covid-19.

Scientists at the University of Massachusetts Chan Medical School in the US have completed six studies to aid in bringing over the counter, at-home Covid-19 tests to market, and are now building on their previous work to learn more about how effective and feasible the tests are for broad-based population screening and how consumers interact with the devices. The studies have been backed by the Rapid Acceleration of Diagnostics (RADx) initiative of the US National Institutes of Health. Going forward, the researcher’s work will attempt to answer questions among regulators about tradeoffs in speed of results, affordability, convenience and accuracy between rapid home antigen tests and more costly, time-consuming polymerase chain reaction (PCR) molecular tests.

9:54 am

Coronavirus company news summary – BD starts shipping of at-home rapid Covid-19 antigen test – University of Colorado team develop genetic markers for Covid-19 severity

BD has commenced shipping of the first over-the-counter (OTC) Covid-19 rapid antigen self-test to leverage computer vision technology in a smartphone to decipher results. The BD Veritor At-Home COVID-19 Test is designed to offer quick and simple Covid-19 testing for users in the at-home setting, using the Scanwell Health app to interpret and deliver a digital display of results in just 15 minutes.

Lucira Health has announced that its self-administered at-home molecular diagnostic test to detect Covid-19 is available for online purchase. The LUCIRA CHECK IT COVID-19 Test Kit has obtained Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for OTC usage. It can offer a positive result in just 11 minutes and a negative result in 30 minutes, demonstrating accuracy of 98% in clinical trials.

Researchers at the University of Colorado School of Medicine and UCHealth University of Colorado Hospital have found genetic biomarkers that can both detect Covid-19 infection and predict the severity of the disease. According to the study, certain signals from DNA methylation differ between Covid-19 infected and uninfected individuals, which could potentially signify severity even in the initial stages of the infection.

9:57 am

Coronavirus company news summary – US announces new investment to boost access to Covid-19 tests – Intelligent Fingerprinting saliva-based Covid-19 test receives CE mark

The US Government has committed to making an additional investment to boost the availability of Covid-19 test kits and reduce associated costs. According to a US Department of Health and Human Services (HHS) statement, the National Institutes of Health (NIH) will invest $70m to bring more at-home tests onto the market in the US in collaboration with the Food and Drug Administration (FDA). As part of the initiative, NIH’s new Independent Test Assessment Program (ITAP) will work to accelerate the review process of potential Covid-19 tests.

Intelligent Fingerprinting’s VSS-GP Covid-19 Saliva Test has secured CE marking and is now available for sale. The test uses a cheek swab mixed with a reagent buffer to provide a positive or negative result within 20 minutes. The test can be used for Covid-19 testing in educational institutions, workplaces and other public events.

LexaGene Holdings has completed analytical studies of its automated pathogen detection system MiQLab, as required by the US FDA for an Emergency Use Authorization (EUA) for Covid-19 diagnostics. According to the company, the device is expected to be classified as a Class II medical device by the FDA. A third party will now carry out a Covid-19 clinical evaluation using the MiQLab System at a POC testing facility and a clinical laboratory. Subsequently, all data will be compiled and submitted to the FDA for authorisation.

10:11 am

Coronavirus company news summary – MSU scientists develop rapid Covid-19 antibody test – Isreal likely to cancel Covid-19 serology tests for children

Scientists at the Mississippi State University College of Veterinary Medicine in the US have developed a new method to quickly identify Covid-19 neutralising antibodies, which has now been recognised with a TechConnect Innovation Award. The novel test uses a chimeric receptor protein to distinguish neutralising antibodies from non-neutralising ones. It also delivers results in just 15 minutes using specimens obtained with a finger prick.

The Isreal Ministry of Health is likely to recommend cancelling antibody tests for children aged five to 11 once vaccinations are rolled out for this group in order to improve vaccination rates, reports Times of Israel. Children in Israel currently have to test positive for Covid-19 antibodies to obtain a ‘Green Pass’, which then permits them to enter public venues. Once vaccinations are available for this age group, this will be the only way to obtain the pass, sources have told Israel’s Channel 12 News.

The Kennewick School District (KSD) in the US has started providing a Covid-19 testing programme called ‘Test to Stay’ in all the schools in the region. The programme is intended for non-symptomatic students who have come in close contact with a Covid-19-positive person at the school or a school-related event, NBC reported. The new programme intends to permit such students to continue attending school as long as they do not have symptoms and test negative for Covid-19 using the Abbott BianaxNOW COVID-19 Self-Test.

10:10 am

Coronavirus company news summary – FDA grants EUA for Xtrava Health’s rapid Covid-19 antigen test – US faces shortage of rapid Covid-19 antigen tests

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Xtrava Health’s SPERA COVID-19 Ag Test for use in point-of-care settings. The rapid lateral flow immunoassay can identify the SARS-CoV-2 virus in shallow nasal samples to deliver results in 15 minutes. With a sensitivity and specificity of 92% and 97% respectively, the test demonstrated the ability to identify all key variants of the virus, including the Delta, Lambda, and Mu.

The US is facing a shortage of rapid Covid-19 antigen tests due to a rise in demand from users and businesses ahead of the country’s vaccine mandate deadline for workers on 22 November this year. As per the mandate, workers should either submit proof for vaccination or perform weekly testing, the Financial Times reports. Limitations have been placed by pharmacy chains on customer purchases while some test providers have informed certain companies that they would be unable to deliver more kits ahead of this deadline.

Medikabazaar has entered an exclusive partnership to supply Korean company Boditech Med’s in-vitro diagnostic solutions across India. As part of the collaboration, Medikabazaar will distribute Boditech’s automated desktop analysers such as the AFIAS 1 and AFIAS 6 immunoassay analysers together with a variety of diagnostic kits and reagents, EH News Bureau reports. These will offer Covid-19 diagnostics as well as diagnostic solutions for cancer, cardiac, diabetes, hormonal and other diseases including dengue, rota and adenovirus.

9:56 am

Coronavirus company news summary – Sorrento’s Covid-19 rapid antigen test obtains CE mark – India grants emergency approval to LumiraDx’s Covid-19 antigen test

Sorrento Therapeutics has obtained a CE mark for its rapid Covid-19 diagnostic test COVISTIX. The test is designed to identify the SARS-CoV-2 nucleocapsid antigen in nasal or nasopharyngeal samples. COVISTIX can reportedly deliver results in nearly 15 minutes with a sensitivity of 81%. The test has received Emergency Use Authorization (EUA) in Mexico while EUA filings are progressing in the US, Canada, Brazil and with World Health Organization (WHO).

India’s Central Drugs Standard Control Organisation has granted emergency use approval to LumiraDx’s SARS-CoV-2 Antigen test. Designed to identify antigen nucleocapsid protein of SARS-CoV-2 virus from a nasal swab sample, the test provides results in less than 12 minutes from sample application. In clinical trials, the test was found to have a 97.6% positive agreement and 96.6% negative agreement in individuals within the initial twelve days of the first onset of symptoms. LumiraDx SARS-CoV-2 Antigen test is already available in the US and Europe.

Quest Diagnostics and Ginkgo Bioworks have entered into an agreement with the Texas Department of State Health Services (DSHS) to offer Covid-19 testing services to Kindergarten through Senior (K-12) schools. The move is aimed to facilitate safer classroom learning in Texas. Ginkgo will provide support services including online reporting and site staffing for the testing programme, while Quest will conduct polymerase chain reaction (PCR) tests and deploy various nucleic acid amplification test technologies through its labs in Houston and Dallas-Fort Worth.

10:09 am

Coronavirus company news summary – Intrivo introduces at-home rapid Covid-19 antigen self-test – Aptar CSP to boost production of Covid‐19 test kit protection technology

US-based Intrivo has introduced On/Go, an at-home rapid Covid-19 antigen self-test. The company says the test can deliver results with 95% accuracy in ten minutes. On/Go has already received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). Intrivo also launched a companion app that will enable the users to view, track and share test results. Users can order the test online at different e-commerce websites. Additionally, Intrivo received a US Department of Defense contract to distribute On/Go tests to 25,000 locations across the country.

Israel Defense Forces (IDF) has bought hundreds of remote Covid-19 testing devices, reports The Jerusalem Post. Developed by local start-up Tyto Care, the device will allow people to test their heart rate, body temperature as well as examine their heart, lungs and throat, ears, skin, abdomen, heart rate and body temperature. Results will be shown via the company’s companion app. According to the news report, the procurement will help shift patients with mild Covid-19 infections to home care, reducing overload in hospitals as they monitor their health using the remote Tyto Care device. More than 150 hospitals and clinics across the world already use the device for remote treatment.

Aptar CSP Technologies has secured a $19m contract from the US Government to boost the domestic production capacity of its Activ‐Film technology, which is used to protect Covid‐19 test kits. Activ‐Film technology is integrated into diagnostic dipsticks and lateral flow cassettes to absorb moisture and prevent other environmental degradants from impacting the integrity of the test kits. The funding will be used to purchase equipment to increase production of Activ‐Film material at Aptar’s Auburn, Alabama plant.

9:31 am

Coronavirus company news summary – US FDA warns of potential false positives with Abbott Covid-19 test kits – Australia’s TGA approves Covid-19 rapid antigen self-tests

The US Food and Drug Administration (FDA) has issued an alert regarding potential false-positive results with some Abbott Alinity Covid-19 test kits. The false-positive results are due to the software associated with the Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit. Abbott has recalled the tests in order to correct the software issue, and the kits can continue to be used following the implementation of the software correction. The FDA advised caregivers to consider any positive result from tests using such kits to be presumptive and retest the patients using other authorised alternatives.

Australia’s medicine and therapeutic regulatory agency the Therapeutic Goods Administration (TGA) has approved five Covid-19 self-tests for use in the country. The approved rapid antigen self-tests include three products from China’s Hangzhou Alltest Biotech. Two of these tests are oral fluid tests, while the third one is a self-administered nasal swab. TGA also green-lighted a nasal swab test from Hangzhou Biotest Biotech and SD Biosensor’s self-testing kit. All these test kits will hit the shelves on 1 November.

LumiraDx has filed an Emergency Use Authorization (EUA) request with the FDA for its SARS-CoV-2 and Flu A/B rapid antigen test. The microfluidic immunofluorescence assay is developed to swiftly identify influenzas A and B as well as Covid-19, providing results in around 12 minutes.

10:09 am

Coronavirus company news summary – Eurofins receives grant to boost DNA production for Covid-19 testing – Covid-19 testing with pooled samples effective and cost-efficient, finds study

The researchers at the University College London in the UK have found that the lateral flow tests (LFTs) are more precise in identifying Covid-19 patients and detecting those who can be infectious than previously thought, the BBC reports. Using a novel formula to assess LFT’s accuracy, the team found that the tests had an effectiveness of over 80% in identifying any level of infection and more than 90% effectiveness in most infectious individuals. The researchers stressed that people obtaining a positive LFT result should trust the tests and self-isolate.

The US Department of Air Force, in partnership with the Department of Health and Human Services (HHS), has granted an award of $30m to Eurofins Genomics to set up a manufacturing facility in the US. The contract will help boost the country’s production capacity for the reagents required for Covid-19 diagnostic tests. The site will manufacture GMP grade synthetic DNA called oligonucleotides (oligos) for molecular diagnostic testing. The facility will come up near Eurofins’ existing site in Louisville, Kentucky.

A study has found that testing pooled saliva samples for Covid-19 every two weeks at a residential college campus resulted in a more than 95% agreement with the gold standard for accuracy, nasopharyngeal samples tested individually. Making use of pools of ten samples, the test delivered results in under eight hours. The cost for processing an average of 665 tests weekly was $0.43 for each sample, indicating the cost-effectiveness of the method.

10:14 am

Coronavirus company news summary – AXIM develops rapid Covid-19 neutralising antibody test – Singapore approves Lucira Health’s Covid-19 test kit

AXIM Biotechnologies has developed a second-generation version of its rapid neutralising antibody test for Covid-19. The new test shows whether the user has responded to the Covid-19 vaccine in just ten minutes. It also delivers a semi-quantitative analysis of their neutralising antibody levels. Currently being analysed by the US Food and Drug Administration (FDA), the original test measures levels of functional neutralising antibodies that are thought to prevent SARS-CoV-2 from entering host cells.

Nutriband has entered an agreement with US-based Diomics to manufacture the Diocheck Transdermal Test, a visual Covid-19 antibody indicator patch. Leveraging the FDA-cleared Diomat bioresorbable polymer of Diomics, the test checks and reports if an individual has developed a circulating level of Covid-19 specific antibodies in 24 to 36 hours. A positive response leads to a change in colour of the skin, visible through the Diocheck skin patch.

Singapore’s Health Sciences Authority has granted approval to medical technology company Lucira Health’s LUCIRA CHECK IT COVID-19 Test Kit through its pandemic special access route. The self-test can be carried out anywhere, any time and delivers laboratory-quality molecular results in just 30 minutes after obtaining the sample. The company also collaborated with Labgistics Asia to import and supply the test to the region.

9:54 am

Coronavirus company news summary – Germany ends free rapid Covid-19 antigen tests – Compass Community Health to provide at-home Covid-19 test for free

Germany has decided to no longer offer rapid Covid-19 antigen tests for free as part of new rules aimed at boosting vaccination numbers. The tests have been funded using taxpayer money since March this year. Now, they will only be available for free to children aged under 12 and people who cannot get vaccinated for medical reasons, The Local reported. Free tests will be offered to people aged 12 to 17 years and pregnant women until the end of this year.

NxGen MDx is set to extend its existing drive-through Covid-19 testing site in Holland, Michigan, US to a new location in Grand Rapids. At the new site, full-time Covid-19 polymerase chain reaction (PCR) tests, 15-minute rapid antigen tests and COVID Plus tests for detecting influenza A/B and SARS-CoV-2 will be offered. Kent County is currently seeing an average of 266 Covid-19 cases in a day.

Compass Community Health in the US, a member of the Ohio Association of Community Health Centers (OACHC), is set to supply more than 400 Abbott BinaxNOW at-home Covid-19 test kits to at-risk area residents for free to reduce disease spread in the region. The kits have an accuracy of 84.6%, and contain the necessary nasal swab, instruction manual and other components to carry out the test in the at-home setting, The Portsmouth Daily Times reported.

9:38 am

Coronavirus company news summary – Grey Bruce Public Health warns against use of rapid antigen tests for Covid-19 – Philippines’ Angeles University develops Covid-19 test kits

Arizona State University in the US has completed its one-millionth Covid-19 saliva test, which was discovered and developed by the university. Almost 40% of the tests have been given to ASU students, employees and partners. While nasal swab sample collection is more risky for healthcare staff, as it requires them to come in close contact with a possibly sick, unmasked individual, the saliva-based tests allows them to maintain social distance as the subject collects the sample temselves. In January, ASU recorded the maximum number of samples processed in one month, which stood at 131,423.

Grey Bruce Public Health in Ontario, Canada has warned against the usage of rapid antigen testing for Covid-19 diagnosis upon developing any symptoms. Rapid antigen test should not be used as a detection tool for testing symptomatic individuals as it has an increased rate of failure, the health unit noted. Such tests are not deemed reliable to confirm a positive or negative Covid-19 result in symptomatic people.

A team at the Angeles University Foundation Center for Advanced Research and Innovation (AUF-CARI) in Central Luzon, Philippines is a number of different Covid-19 test kits. One test kit can identify an individual’s immune response against Covid-19 from using blood samples, and two saliva-based test kits have been developed – one antigen test, and one antibody test. The tests have been shown to have a precision of 90% in clinical validation.

9:47 am

Coronavirus company news summary – Achiko launches Covid-19 diagnostic test pilot in Indonesia – US FDA issues EUA for PerkinElmer’s Covid-19 test

Achiko has launched a pilot programme of its rapid Covid-19 diagnostic test AptameX in combination with digital health passporting app Teman Sehat in Indonesia. AptameX uses a DNA aptamer-based technology, which the company says improves on the speed of lateral flow tests (LFTs) while matching them in sensitivity.  Those that test positive are alerted promptly through the Teman Sehat app and asked to follow local guidelines on isolation and quarantine. The pilot will be held at three sites and will assess unit economics and help train staff and demonstrate the service as a precursor to sales. The move comes nearly two months after Indonesia granted product and registration approval for AptameX.

The US Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for PerkinElmer’s PKamp Respiratory SARS-CoV-2 RT-PCR Panel 1 assay. The test can identify and distinguish SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus (RSV). Qualified laboratories can immediately start using PKamp assay for simultaneous and qualitative detection of the diseases from nasopharyngeal swabs, anterior nasal swabs and mid-turbinate swabs.

Total Testing Solutions (TTS) is providing quick turnaround antigen and PCR testing for Covid-19 free of charge in Los Angeles, US. The free rapid PCR testing is available at the TTS Century City location, while rapid antigen tests can be procured from multiple TTS sites throughout the Los Angeles area. Insured and uninsured patients can use the service, with the billing directed either through their insurance or the CARES initiative.

10:08 am

Coronavirus company news summary – US to buy additional 180 million rapid Covid-19 tests – SkyWater, NanoDx to produce sensors to improve rapid Covid-19 testing

The US Government is set to purchase additional 180 million rapid Covid-19 tests in a bid to ensure the availability of test kits across the country. The move will involve an investment of around $1bn, Reuters reported. This investment is in addition to the $2bn commitment made by the government last month to procure test kits. In the US, the production of Covid-19 tests is expected to touch around 200 million per month by December.

SkyWater Technology and NanoDx have entered into a technology transfer collaboration to produce nanoscale sensors that can enhance and expand rapid testing for several indications, including Covid-19. The partnership will enable NanoDx to scale the product and advance with the plan to seek an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a two-minute, point-of-care Covid-19 test. The NanoDx System is designed to identify and quantify biomarkers from a small fluid specimen in less than two minutes.

Todos Medical and its joint venture (JV) partner NLC Pharma have reported positive data from a clinical study that evaluated 3CL protease biomarker assay TolloTest. The trial assessed the sensitivity of the assay compared with PCR in hospitalised Covid-19 patients, other hospitalised patients and individuals exposed to confirmed Covid-19 subjects. The data indicates 100% sensitivity in identifying fully vaccinated asymptomatic Covid-19 patients, after one to three days of exposure.

9:12 am

Coronavirus company news summary – US FDA warns of potential false positives with Ellume’s Covid-19 test kits – Covid-19 test kit manufacturers in US to ramp up production

The US Food and Drug Administration (FDA) has issued a safety communication to alert caregivers regarding potential false-positive results with certain Ellume Covid-19 Home Test kits. The move came days after Ellume voluntarily recalled some batches of test kits due to similar concerns. The company also noted that it has identified the root cause and implemented additional controls. The FDA is now working with Ellume to resolve the issue.

The FDA has granted Emergency Use Authorization (EUA) for Euroimmun’s Anti-SARS-CoV-2 S1 Curve ELISA. This assay enables qualitative and semi-quantitative detection of IgG antibodies formed in human serum and plasma against the SARS-CoV-2 S1 antigen. The measurement of IgG antibodies can help in future discoveries as well as help in gaining insights on immune responses to Covid-19.

Covid-19 test kit manufacturers in the US, such as Abbott Laboratories, Quidel Corp and LumiraDX, are working to ramp up production to meet increasing demand, reports Reuters. This comes amid a shortage of rapid Covid-19 tests across several states.

9:59 am

Coronavirus company news summary – OraSure secures contract to increase production of Covid-19 rapid tests – Northwell Labs starts using Covid-19 PCR test to screen employees

OraSure Technologies has secured a $109m contract from the US Department of Defense (DoD) to boost production of its InteliSwab Covid-19 rapid tests. OraSure’s production capacity is expected to touch 100 million tests per year by March 2024. InteliSwab uses a swab from the lower nostrils and can deliver results within 30 minutes. It has received three Emergency Use Authorizations (EUAs) from the US Food and Drug Administration (FDA) for professional point-of-care use, prescription home use and over-the-counter use.

US-based healthcare network Northwell Health has started using LabGold, a polymerase chain reaction (PCR) test which uses a self-collected specimen to screen employees for Covid-19. The test was developed using funding from the Bill & Melinda Gates Foundation along with Corteva Agriscience, Quantigen and SteriPack. In future, Northwell plans to expand the use of LabGold by using a $2.5m grant from the Gates Foundation.

The FDA has granted EUA for the ACON Laboratories Flowflex Covid-19 Home Test. This Flowflex test is an over-the-counter Covid-19 antigen test that can be used at home without a prescription. The EUA is expected to increase the availability of OTC tests, boosting at-home testing capacity in the US. ACON plans to deliver more than 100 million tests per month by the end of this year.

10:35 am

Coronavirus company news summary – Abu Dhabi to offer wearable tech to high-risk Covid-19 patients – Adaptive Biotechnologies provides new data on T-Detect Covid test

Labcorp has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its home collection kit that can detect Covid-19 and influenza A/B simultaneously. The kit can be used by individuals as young as two years of age. It is expected to help people determine whether they have Covid-19 from the safety of their home during flu season. The kit can be ordered online and the test results will be available in one or two days after Labcorp receives the completed collection kit.

Abu Dhabi is set to offer a wearable device to high-risk Covid-19 patient groups, according to The National News. The wrist-bourne device is reportedly capable of tracking oxygen saturation, temperature and heart rate. Healthcare staff monitor the data on a dashboard that charts the readings and will alert the patient if they spot any abnormalities. The move follows a successful pilot by the Abu Dhabi Health Services Company.

Adaptive Biotechnologies has presented new data regarding T-Detect Covid, a T-cell test, during IDWeek 2021. The new real-world data shows that T-Detect Covid can detect prior SARS-CoV-2 infection around 12 months after initial diagnosis in some patients. The test can be used to differentiate between natural SARS-CoV-2 infection and Covid-19 vaccine response. T-Detect is a specific test currently under development to detect multiple diseases, with T-Detect Covid being the first commercially available T-cell test to identify SARS-CoV-2 infection. The test has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).

9:40 am

Coronavirus company news summary – QIAGEN to increase US production of Covid-19 tests – Longhorn and SiO2 partner on test transport tubes for large labs

QIAGEN has secured a new contract from the US Government to boost production capacity for Covid-19 tests running on NeuMoDx instruments. The $3.4m contract was awarded by the Department of Defense (DoD). Under the contract, QIAGEN will increase production of PCR tests for NeuMoDx 96 and 288 clinical integrated systems at its site in Michigan. The company aims to ramp up production by the end of March 2022 from 10 million tests a year to more than 16 million.

Longhorn Vaccines & Diagnostics and SiO2 Materials Science have entered into a partnership to deliver FDA-cleared sample collection system PrimeStore MTM in 12mm sample transport tubes. The SiO2-manufactured sample transport tubes are available for testing Covid-19, influenza and other viruses. The use of transport tubes will enable large laboratories to pool ten times more samples with one-tenth of the required materials, the partners said. The combination will also allow labs to use one tube to test multiple viruses.

Curebase has supported InBios International in gaining Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its SCoV-2 Detect IgG Rapid Test. Curebase ran a decentralised clinical trial of the antibody test to procure necessary data for FDA requirements. In a clinical evaluation, InBios’s SCoV-2 Detect IgG Rapid Test determined 96.9% (PPA) of those who were positive and 100% of those who were negative (NPA) for SARS-CoV-2 (COVID-19) IgG antibodies. The test is designed to identify individuals who have an adaptive immune response to SARS-CoV-2.

10:07 am

Coronavirus company news summary – ClearMask launches FDA-approved and CE-marked transparent surgical mask – Medical device company Orthofix warns lower revenue growth

US-based medical supply company ClearMask has introduced a fully transparent surgical mask. The CE-marked offering received Food and Drug Administration (FDA) clearance as a Class II medical device last year. The use of the transparent mask is expected to facilitate communication while ensuring high levels of protection. It can be used in hospitals, clinics, schools and other places.

Musocskeletal medical device company Orthofix Medical has said in a business update that its third-quarter revenues will likely record a low single-digit increase on a year-on-year basis due to higher volumes of deferred or rescheduled elective procedures in the US and internationally following the latest surge in Covid-19 Delta variant cases. US-based Orthofix focuses on delivering musculoskeletal products and therapies.

Fintech company Beep Technologies, in collaboration with IHH Healthcare Singapore‘s hospitals, is installing antigen rapid test (ART) kit vending machines in Singapore. According to the Straits Times, around 20 such vending machines have now been deployed at private hospitals and company offices. The move will help the workers to test themselves for Covid-19, reducing pressure on the healthcare system. Each of the vending machines can store up to 480 test kits.

10:03 am

Coronavirus company news summary – Zymo Research donates Covid-19 test kits to Mapmygenome in India – Australia to allow companies to supply Covid-19 self-testing kits for home use

Zymo Research has donated one million Covid-19 test kits to Indian molecular diagnostics company Mapmygenome. The delivery includes Zymo Research’s new DNA/RNA Shield – DirectDetect reagent and swab collection devices. This reagent safeguards viral RNA from degradation and ensures safe, ambient temperature collection and transportation of samples without nucleic acid extraction.

New research has shown that a blood test can help identify healthcare professionals experiencing high levels of stress amid the ongoing Covid-19 pandemic. The research was presented at the 2021 AACC Annual Scientific Meeting & Clinical Lab Expo after a research team from Alexandria University Hospitals in Egypt identified a positive correlation between copeptin in blood levels and psychological stress. The study included 70 physicians and nurses who were treating Covid-19 patients in the ICU.

Australia’s Therapeutic Goods Administration (TGA) is set to enforce new regulations to enable companies to supply Covid-19 self-testing kits for use at home from 1 November. The move will allow citizens to buy such kits from pharmacies and online stores. In a statement, TGA said that the companies need to secure regulatory approval to start supplying self-test kits.

10:01 am

Coronavirus company news summary – US FDA grants EUA to ANP’s Covid-19 antigen rapid test kit – Millions of diabetes tests missed during Covid-19 lockdown in UK

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to ANP Technologies’ NIDS Covid-19 antigen rapid test kit. The test is developed using ANP’s Nano-Intelligent Detection System (NIDS) technology to provide a visual result in 15 minutes from nasal swab specimens. ANP will now focus on the large-scale production of NIDS Covid-19 antigen rapid test kits.

The Indian Council of Medical Research (ICMR) has reportedly assessed a new and faster RT-PCR testing method to detect SARS-CoV-2. According to Times of India, the test does not extract the virus’s genetic RNA before RT-PCR testing to simplify the process. This reduces test time and provides faster results. The alternative method was evaluated with an independent study. The report added that the new method trimmed over-all test turnaround time by two hours with an overall sensitivity of 78.9%.

New research has estimated that around 2.5 million diagnostic diabetes tests were missed or got delayed in the UK during the six-month Covid-19 lockdown last year. According to news reports, the research was presented at the virtual annual meeting of the European Association for the Study of Diabetes (EASD) this week. The figure was extrapolated using data from six laboratory testing centres in the UK. The study further estimated that an additional 1.4 million monitoring tests in people with diabetes were also missed.

10:48 am

Coronavirus company news summary – Covid-19 test firm Cue Health goes public at nearly $2.5bn valuation – Study finds heart’s electrical activity may predict disease worsening

Cue Health has debuted on the Nasdaq, going public at a valuation of approximately $2.5bn. Cue signed a $481m contract with the US Department of Defense in October 2020 to supply six million Covid-19 test kits and 30,000 readers. As of 31 August 2021, it has delivered over 115,000 readers and over five million cartridges. The company’s Covid-19 test kit consists of a swab, cartridge and reader. It provides results in about 20 minutes to a smartphone app and holds authorisation for emergency use in the US

Medical technology company SeaSpine says that the ongoing Covid-19 pandemic may negatively affect its total revenue for the third quarter of this year. The company now estimates mid-single-digit revenue growth in the third quarter compared to the year-ago period. In a Securities and Exchange Commission filing, the company stated that “ongoing uncertainty regarding the duration and severity of Covid-19 and/or staffing shortages on spine surgery procedure volumes throughout the US” are impacting its ability to confirm the previous revenue guidance for the fourth quarter and full-year.

A new study by Mount Sinai has shown that certain changes on electrocardiograms (EKGs) of hospitalised Covid-19 or influenza patients may forecast a period for worsening health and death, in turn allowing better monitoring and treatment. Shrinking waveforms on EKGs can aid in identifying high-risk patients, researchers added. Diminished waveforms on EKGs in Covid-19 patients could help avoid the possible exposure of more healthcare workers to the infection, as these tests can be carried out simultaneously with other bedside care.

10:22 am

Coronavirus company news summary – Celltrion secures $626m contract from US Government for DiaTrust test – 4DMedical lung scans enable long COVID research

South Korean biopharmaceutical firm Celltrion has received a contract valued at up to $626m from the US Defense Logistics Agency for the supply of its DiaTrust COVID-19 Ag Rapid Test. This 12-month supply contract makes Celltrion the first Korean mass supplier of rapid tests for Covid-19. Celltrion USA will supply the tests on a weekly basis to nearly 25,000 US locations to support military bases, long-term care facilities, community testing sites and other designated sites. The test, which provides results in 15 minutes, holds Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).

Physicians in California, US have been using lung scans from 4DMedical to gain better insights into the effects of long Covid, report Reuters. The lung scans use existing hospital equipment to identify high and low lung ventilation in long Covid patients. The company uses a video sequence of approximately 20 seconds of the patient breathing naturally, which facilitates mathematical calculation of the motion and the airflow in and out of the lungs. The technology also uses algorithms and mathematical models to convert sequences of X-ray images into quantitative data. The scans reveal evidence of lung damage not seen on a CT scan or X-ray, according to 4DMedical chief clinical adviser Dr Ray Casciari.

OraSure Technologies is set to receive up to $13.6m funding from the US Biomedical Advanced Research Development Authority (BARDA) to support the company in obtaining 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for its InteliSwab COVID-19 rapid test. The test has received EUA for point-of-care, prescription, home and over-the-counter settings in the US. It uses an integrated swab for self-collection of a sample from the lower nostrils and delivers results in less than 30 minutes without the need for external instruments, a smartphone or laboratory analysis.

9:52 am

Coronavirus company news summary – England rolls out first domestically produced rapid tests – Chembio applies for EUA for respiratory antigen panel

The first rapid tests manufactured in the UK are being deployed at universities across England to detect asymptomatic Covid-19 cases. Also called lateral flow tests (LFTs), the tests are manufactured by SureScreen Diagnostics and deliver results within 15 minutes. Currently, the company can produce nearly seven million tests weekly and plans to grow the capacity to 14 million per week by the end of December this year. The UK Government says that these tests are an important part of its rapid testing programme to offer LFTs at no cost across the country.

SOTECH Health has sought Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a portable, reusable, rapid, at-home breath test device for Covid-19. The company licensed the platform technology associated with the device from the University of Texas and further optimised it under an intellectual property assignment/sponsored research agreement (IPA/SRA) with the university. A sensor present in the device identifies gaseous metabolites that indicate Covid-19 and results are sent to the company’s cloud and companion smartphone app. People who test positive are directed to receive a standard test to confirm Covid-19.

Chembio Diagnostics has submitted an application to the FDA for EUA for its DPP Respiratory Antigen Panel test system, which can deliver simultaneous and differential identification of influenza A, influenza B and SARS-CoV-2 antigens from one patient sample using a nasal swab. Set to offer results in nearly 20 minutes, the test system can be read on the company’s DPP Micro Reader analyzer. It is intended to help limit the spread of Covid-19 cases in the flu season.

11:21 am

Coronavirus company news summary – US to procure rapid tests from Abbott and Celltrion – Co-Diagnostics Logix Smart test secures authorisation in Mexico

BD is providing a digitally read, rapid antigen test to support its testing and screening efforts for Covid-19 in K-12 schools in Washington, US. The company will offer its portable BD Veritor Plus point-of-care test, which can identify the Covid-19 virus within 15 minutes. Schools across the state will be able to use the test at no cost as part of the collaboration.

The US has entered an agreement to procure rapid Covid-19 tests from Abbott and Celltrion to distribute to nursing homes and other high-risk populations, reports Reuters. As part of US President Joe Biden’s vaccinate or test plans, the government will obtain rapid tests worth approximately $2bn. The deals with Celltrion and Abbott are valued at up to $626m and $554.4m, respectively.

Co-Diagnostics has received authorisation for the sale of its Logix Smart Influenza A/Influenza B/COVID-19 “ABC” Test in Mexico. The Mexican Department of Epidemiology granted the approval after an independent review of the test’s sensitivity and specificity as an RT-PCR multiplex test. Logix Smart, which secured CE Mark last year, is designed to precisely differentiate between influenza A/B and Covid-19.

9:48 am

Coronavirus company news summary – OraSure gets $205m contract for InteliSwab rapid test – Penn researchers create antigen test to identify small viral loads

OraSure Technologies has received a $205m procurement contract from the US Defense Logistics Agency for its over-the-counter (OTC) InteliSwab COVID-19 Rapid Test. As per the contract, which will run from October this year through September next year, the company will provide the rapid test to up to 25,000 sites across the country. InteliSwab is designed to allow self-collection of a sample from the lower nostrils and delivers results in less than 30 minutes. It has received Emergency Use Authorization (EUA) in point-of-care, prescription home and OTC settings in the US.

Researchers at the University of Pennsylvania have developed a rapid antigen test that can identify small loads of the SARS-CoV-2 virus. The sensitivity of the test is reportedly similar to that of a polymerase chain reaction (PCR) test, the current gold standard in the diagnostic industry. The Penn test uses smartphone camera photographs to measure the size and number of tiny, gas-filled bubbles in a chemical reaction from a nasal swab. When evaluated using clinical nasal swabs from 372 patients, the test detected 97% of positive swabs and 97% of negative swabs versus PCR techniques.

The National Institutes of Health (NIH)’s Rapid Acceleration of Diagnostics initiative has awarded a $13.3m contract to the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) to boost Covid-19 testing capacity. The university’s diagnostic laboratory can process up to 150,000 Covid-19 tests daily using SwabSeq, a sequencing technology that UCLA developed. The technology can pool thousands of saliva specimens and delivers individual test results within 24 hours. SwabSeq is considered faster and less expensive compared with the PCR test, with kits already available in vending machines on the UCLA campus for free self-testing.

1:17 pm

Coronavirus company news summary – FDA warns of potential false positives with Abbott tests – Burnet Institute and Doherty Institute develop test to check immunity

The US Food and Drug Administration (FDA) has published a warning that two of Abbott‘s Covid-19 testing kits could deliver false-positive results. The possible false positives can occur with the Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit. This is thought to be associated with the current mixing parameters of the polymerase chain reaction (PCR) reaction mixture, which may cause overflow into neighbouring wells in the assay reagent tray. This overflow into wells of true negative samples placed near positive samples in the tray could lead to false positives. The FDA has recommended retesting of positive samples with another authorised test.

Researchers at Burnet Institute and Doherty Institute in Australia have developed a finger prick test for fast analysis of an individual’s immunity against Covid-19 via measurement of neutralising antibodies to the infection. The COVID-19 NAb-Test, which delivers results within 20 minutes, can help determine if a person needs a vaccine booster. It can also predict immunity to new and emerging SARS-CoV-2 variants. The test is being funded by the Government of Victoria state.

Quadrant Biosciences is set to provide its saliva swab test, the Clarifi COVID-19 Test, to New York businesses with 100 or more employees. This is expected to help businesses reach new testing mandates announced by the US federal government last week. Developed in alliance with SUNY Upstate Medical University, the Clarifi test is designed for self-collection, enabling easy on-site testing. Results are provided in 24-48 hours.

10:10 am

Coronavirus company news summary – Thermo Fisher launches new TaqPath kit to identify viral mutations – FluroTest says saliva-based test system now operational

Thermo Fisher Scientific has introduced the TaqPath COVID-19 RNase P 2.0 kit, which holds the CE-IVD Mark, to detect existing and future mutations of the SARS-CoV-2 virus. The company redesigned the test to identify active infections by spotting the presence of any one of eight SARS-CoV-2 gene targets in nasopharyngeal and nasal swab specimens. It is expected to deliver precise results even after mutations occur.

FluroTech has announced that its novel saliva-based point of access test system and immunoassay to detect SARS-CoV-2 is now fully operational. The new pandemic response platform includes kits to collect saliva, agents to deactivate the virus, the robotic, automated test processing platform and the software that runs it. It also comes with the immunoassay to process saliva samples and the microplate reader to analyse the presence SARS-CoV-2 within the samples. The company is now focusing on commercial product optimisation.

Affinity Empowering has enrolled the University of Arkansas for Medical Sciences (UAMS) Gap Services programme in Operation Expanded Testing (OET), a US Government initiative that offers surveillance polymerase chain reaction (PCR) testing to schools and community organisations to protect against Covid-19. Affinity Empowering provides the OET initiative on behalf of Eurofins Clinical. As part of OET, the UAMS programme is now offering free Covid-19 testing in Arkansas. The initiative uses a PCR test that can identify Covid-19 in the earliest stages when viral load is low, Affinity said.

9:28 am

Coronavirus company news summary – Covid-19 testing firm Prenetics to go public with SPAC merger – iGene Laboratory donates 25,000 PCR Kits to Indonesia

Hong Kong-based Prenetics Group is set to go public on the Nasdaq through a merger with a special purpose acquisition company, Artisan Acquisition Corp., in a deal that values the Covid-19 testing firm at $1.25bn. The combined entity value is estimated to be nearly $1.7bn. In addition to rapid diagnostics for Covid-19, Prenetics focuses on genomic testing and tests for other infectious diseases. The company recently introduced a CE-IVD point-of-care diagnostics and at-home rapid detection health monitoring system for Covid-19. It also offers a laboratory PCR testing solution for the disease, with over five million tests conducted so far.

iGene Laboratory has donated 25,000 SARS-CoV-2 PCR Kits to Indonesia to help the country’s government manage the ongoing Covid-19 pandemic. These kits will be immediately rolled out at the Gatot Soebroto Army Hospital and Dr. Esnawan Hospital in Indonesia. iGene provides a pre-departure test service for Covid-19, where travellers can take a PCR test and obtain digital results.

Dotz Nano has signed a distribution agreement and secured a $220,000 purchase order from Paraguay-based El Alamo to supply its SARS-CoV-2 virus detection technology in the country. Initially, the deal provides El Alamo with the right to sell the Dotz Test Kits in Paraguay for two years with conditional exclusivity. In the country, Dotz holds CE Mark and a Certificate of Free Sale for its nasopharyngeal swab as well as saliva-based test kits.

9:57 am

Coronavirus company news summary – University of Queensland researcher obtains grant to develop rapid test – Jumpcode Genomics partners with TGen for SARS-CoV-2 genomic sequencing

Cepheid has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the use of its Xpert Xpress CoV-2/Flu/RSV plus, a rapid molecular test to qualitatively identify Covid-19, respiratory syncytial virus (RSV) and influenza A and B infections in a single sample. The test offers a third gene target when processing SARS-CoV-2 virus in order to address viral mutations in the future. It can be used with Cepheid’s GeneXpert Systems and provides results in around 36 minutes.

University of Queensland virologist Dr Kirsty Short has received a AU$1.37m grant from the Australian National Health and Medical Research Council (NHRMC). The money will be used to support research into a genetic marker or ‘signature’ in Covid-19 patients. The marker will be leveraged for the new test to identify the viral genetic material earlier than standard polymerase chain reaction (PCR) diagnostics. In addition, the project will involve research on anti-viral therapies that can target several viruses.

Jumpcode Genomics has collaborated with the Translational Genomics Research Institute (TGen) to use CRISPRclean technology to sequence the genome of SARS-CoV-2 and detect and track variants. The companies are working to establish solutions and clinical services that use meta-genomic sequencing and analysis to enable the identification of Covid-19 and various other infectious diseases. TGen researchers are currently analysing Covid-19 samples that were already assessed with PCR tests to check the metagenomic diagnostic’s sensitivity and specificity versus standard PCR-based testing.

9:45 am

Coronavirus company news summary – Auburn researchers develop electronic device for instant test results – FDA expands emergency use of Quanterix’s antigen test

Visby Medical has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its reverse transcription-polymerase chain reaction (RT-PCR) Covid-19 test for pooled patient samples. The instrument-free test previously obtained EUA for single sample testing in point of care settings. With the latest authorisation for testing of up to five samples simultaneously, the company expects an increase in overall lab testing capacity with no other tools or resources needed. The test provides results within 30 minutes.

Researchers and engineers at Auburn University have created an electronic device to instantly identify the Covid-19 virus spike protein. The device is made of two-dimensional materials altered with antibodies. As soon as a sample drop is placed on the device, the virus spike protein interacts with the antibody and the result is shown.  In addition, the faster results delivery could facilitate quicker treatment for Covid-19 positive individuals.

The FDA has expanded the EUA label for Quanterix’s Simoa SARS-CoV-2 N Protein Antigen Test to allow the use of nasal swab and saliva samples, as well as asymptomatic serial testing using nasal swab specimens. The company says it is the first antigen test to secure authorisation for saliva samples. The test can detect all variants of concern that are now designated by the Centers for Disease Control (CDC). Quanterix added that Simoa is the first non-NGS test confirmed to identify the Delta variant (B.1.617.2) in sequence-confirmed clinical samples.

10:01 am

Coronavirus company news summary – Indiana state selects Gravity Diagnostics to boost testing – Nomi Health expands capacity for mobile testing

The Indiana Department of Health, US, has collaborated with Gravity Diagnostics to enhance free Covid-19 testing across the state. The company evaluate up to 5,000 Covid-19 tests daily, including rapid antigen and polymerase chain reaction (PCR) tests. The testing initiative is expected to expand to up to 45 sites based on the requirements. The initial contract is valid until 30 June 2022 and may extend.

The UK’s Competition and Markets Authority (CMA) has published advice for the government about improving the private travel PCR testing market for consumers. This included improving basic quality standards, initiating a monitoring and enforcement programme and using the NHS Test and Trace travel test as a gold standard for price and quality. It has already warned several PCR test providers about breaches of consumer law and has started a probe into Expert Medical. Another 19 test providers have also been asked to adjust their pricing information.

Nomi Health has opened more than 12 new mobile testing sites to meet the growing demand for Covid-19 testing in Utah, US. The company will hire more than 200 medical professionals for the TestUtah Mobile Testing Initiative via expanded collaboration with the state, offering Covid-19 tests from Co-Diagnostics.

9:34 am

Coronavirus company news summary – XPhyto introduces 25-minute rapid RT-PCR test – Co-Diagnostics says Logix Smart Test Kit used in surveillance method

XPhyto Therapeutics has launched a 25-minute rapid reverse transcriptase-polymerase chain reaction (RT-PCR) test, named COVID-ID Lab, to qualitatively identify the SARS-CoV-2 virus. The test does not involve preceding RNA extraction for sample preparation. In a pilot project at test centres in Berlin, Germany, the operational procedures and protocols have been optimised for the quick, effective and reliable use of the test. At present, XPhyto and its partners are working on a modular hygiene- and testing-concept integrating COVID-ID Lab for large events, including concerts, conferences and sporting events.

Co-Diagnostics has announced that its Logix Smart COVID-19 Test Kit has been used by an Italian research team to detect SARS-CoV-2 and its mutated strains by testing single-use waste as part of a community surveillance method. Saliva left on single-use glasses and bottles was analysed to check for the presence of the Covid-19 virus at 20 different sites in Northern Italy during January and February this year, which was the second Covid-19 peak period.

Healthcare firm Diversified Medical Healthcare (DMH) has relaunched the RapidRona at-home RT-PCR test for Covid-19. The test, which holds Emergency Use Authorization (EUA) from the US Food and Drug Administration, delivers results within 48 hours. Users can self-collect nasal swab samples at home.

10:03 am

Coronavirus company news summary – Rhinomed to trial nasal swab for children – Project N95 offers Quidel’s QuickVue At-Home OTC test

Abingdon Health has launched a score-card product, for use with its AbC-19 rapid test. The new product offers a semi-quantitative result suggesting the antibody response strength and potential immunity of the user. The AbC-19 lateral flow device identifies the presence of IgG neutralising antibodies to the SARS-CoV-2 spike protein. The accessory is intended to help gain better insights into immune response.

Rhinomed has received ethics approval to conduct a clinical trial of the world’s first nasal swab designed for children. Rhinoswab Junior is intended to obtain a nasal sample from children without the discomfort and distress linked to the combined throat and deep nasal (CTDN) swabs. The trial will be performed at The Royal Children’s Hospital Melbourne to compare Rhinoswab to the current standard of care CTDN swab in nearly 250 children for diagnosing respiratory viruses, including Covid-19.

Non-profit Project N95 has added Quidel’s QuickVue At-Home OTC COVID-19 Test to its product range. The rapid test can be used without prescription and delivers results in ten minutes. It is designed to qualitatively detect the nucleocapsid protein antigen from SARS-CoV-2 in people with or without symptoms. The test can be used with self-collected direct anterior nasal swab samples from people aged 14 years or above or with adult-collected anterior specimens from those aged two years or above.

9:25 am

Coronavirus company news summary – Omega Diagnostics seeks CE Mark for antigen self-test – NYUAD team uses hair cortisol test to identify Covid-19-related stress levels

Omega Diagnostics Group has submitted all supporting data and documentation necessary to seek a CE mark for its VISITECT COVID-19 antigen test self-test. The test already holds a CE mark for professional use, but this application would permit its sale for at-home use. The company completed the submission process after the conclusion of the test’s useability study by Ulster University.

Exhalation Technology has developed CoronaCheck Lite, a test for rapid Covid-19 diagnosis using nasal swabs and saliva samples. The cost-effective test leverages an electrochemical biosensor and a sensor strip that is placed within a portable handheld and reusable analyser. It can deliver results in five minutes without any sample handling, the company says. Previously, Exhalation Technology developed another rapid Covid-19 test called CoronaCheck, based on its exhaled breath diagnostics expertise.

The Government of Singapore has announced plans to boost pervasive testing and other measures to swiftly identify and lower Covid-19 infections in workplaces. The announcement comes after new infection cases in the community nearly doubled in one week. Beginning next week, the country’s Fast and Easy Test (FET) Rostered Routine Testing (RRT) regime will be updated to raise testing frequency from once a fortnight to once per week. Testing will also be expanded to more workers in higher-risk settings.

Researchers at NYU Abu Dhabi (NYUAD), in alliance with Global TIES for Children and scientists at the University of California Davis and Hashemite University in Jordan, have utilised a hair cortisol test to identify the effect of Covid-19 on stress levels in families. Findings revealed that personalised assistance is needed to support the requirements of families at risk in order to avoid the adverse physiological and psychological impact of the ongoing pandemic.

10:21 am

Coronavirus company news summary – UK CMA opens formal investigation into PCR travel test provider – Researchers use home blood collection device for Covid-19 antibody test

The Competition and Markets Authority (CMA) in the UK has opened a formal investigation into Covid-19 travel PCR test provider Expert Medicals. The move follows several complaints alleging that the company failed to provide tests and results within the stipulated timeframes necessary to permit customers’ travel plans and did not respond to complaints. Expert Medicals also allegedly refused to pay refunds. The government has since removed the name of the company from the list of approved travel testing providers. Separately, CMA has warned 19 other test providers for misleading practices regarding pricing information.

A team of researchers at Japan’s RIKEN Center for Emergent Matter Science (CEMS) has developed a diagnostic system that can determine the number of SARS-CoV-2 antibodies needed to protect people from Covid-19. The system immobilises several key SARS-CoV-2 proteins to facilitate the detection of antibodies and is expected to help in assessing the efficacy of the Covid-19 vaccines.

Researchers from the University of Washington have used a novel blood collection device to measure SARS-CoV-2 antibodies. The Tasso-SST kit uses a gentle vacuum to draw blood from capillaries under the skin, rather than from the vein through a needle. The researchers found no significant differences in antibody levels in blood samples from the device versus standard techniques, indicating that the device may help reduce the need for visiting clinics for such tests.

9:52 am

Coronavirus company news summary – LumiraDx introduces onsite surveillance test – Thermo Fisher gets contract to boost domestic pipette tips production

LumiraDx has announced the US launch of its rapid onsite surveillance test for Covid-19 at settings suchs as schools and workplaces. The LumiraDx SARS-CoV-2 Ag Surveillance Test can be used for concurrent testing of up to five samples on a small, portable instrument. It delivers digital results in under 12 minutes. The test is intended to measure real-time population health metrics to aid in preventing the spread of Covid-19, LumiraDx said.

Thermo Fisher Scientific has received a $192.5m contract from the US Department of Defense to expand domestic manufacturing of pipette tips used in research and diagnostic labs. The company and the US government will jointly invest in a new production facility for pipette tips, which are required in high volumes for processing diagnostic tests in the country, including Covid-19. The new facility is expected to complete in 2024.

Applied DNA Sciences has secured a testing contract from Suffolk County Community College to track Covid-19 prevalence among the college’s unvaccinated staff and faculty. Testing as part of Applied DNA’s safeCircle Testing Program is set to start this month and will use the company’s Linea COVID-19 Assay Kit. The initial term of the contract is one year and covers two one-year options for renewal.

9:40 am

Coronavirus company news summary – Seegene gets CE-IVD Mark for Combo Swab self-collection device – SpeeDx to supply molecular assay in UK

South Korean diagnostics firm Seegene has secured CE-IVD Mark for its Combo Swab self-collection device with four diagnostic assays. The swab is intended for at-scale sample collection, enabling patients to easily obtain samples from the nasal and oral cavities under a healthcare professional’s supervision. With the CE Marking, Combo Swab can be used with Seegene’s Allplex SARS-CoV-2 Assay, Allplex SARS-CoV-2 Master Assay, Allplex SARS-CoV-2 Variants I Assay and Allplex SARS-CoV-2/FluA/FluB/RSV Assay.

Quidel is set to offer its non-prescription QuickVue At-Home OTC COVID-19 Test for customers at more than 7,000 CVS Pharmacy locations in the US and the retailer’s online store, beginning next week. One pack of the test will comprise two rapid antigen self-tests. The move is intended to meet the increased customer demand for the test, Quidel said. The company aims to achieve a target run-rate capacity of nearly 70 million rapid antigen Covid-19 tests a month by the end of 2021.

SpeeDx has become part of the new Public Health England (PHE) National Microbiology Framework to provide diagnostic goods and services in the UK. Under the framework’s Lot 1, SpeeDx will enable non-exclusive access to its in-vitro diagnostics and related services to participating public health authorities. The company’s offerings involve a dual-target molecular assay for Covid-19, called PlexPCR SARS-COV-2.

11:11 am

Coronavirus company news summary – Microbiologics offers whole virus antigen control for point-of-care tests – Genetic test maker DnaNudge raises $60m to rollout PCR test

Microbiologics has introduced a SARS-CoV-2 quality control product for use with antigen point-of-care Covid-19 diagnostics. The inactivated Whole Virus Antigen Control can act as a non-viable, external, positive control to assess the assay’s performance, lowering the risk of false-negative or false-positive results. The product consists of wholly intact genomic and viral proteins, allowing its use with antigen tests as well as nucleic acid amplification tests.

Beroni Group has reported that its SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method) showed an overall sensitivity of 95% and 100% specificity in a new clinical study, which involved 70 subjects with 105 true-positive samples and true-negative samples each. With nasal specimens, the test kit demonstrated 92% sensitivity, while nasopharyngeal and oropharyngeal sampling led to a sensitivity of 97% and 95%, respectively. Specificity was 100% with all sampling methods.

Consumer genetic testing firm DnaNudge has raised $60m in a Series A investment round to fast-track the global rollout of its CovidNudge RT-PCR Covid-19 test that can be performed outside of a laboratory. The portable, point-of-care test provides results in just over an hour. The test will be supplied through wholesale agreements with healthcare companies and medical groups. DnaNudge intends to primarily offer the test in the US, Japan, Europe and additional major territories.

10:53 am

Coronavirus company news summary – Empowered Diagnostics submits updated EUA to FDA for rapid test – Purdue University researcher creates paper-based Covid test

AXIM Biotechnologies production partner Empowered Diagnostics has submitted a revised Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) for ImmunoPass, AXIM’s rapid test to identify Covid-19 neutralising antibodies at point-of-care. The updated application says that the test results will be read as qualitative. In addition, the revisions comprise updated trials, BSL3 lab live virus comparisons, stability and control studies and the test’s robustness study.

PHASE Scientific has secured EUA from the Republic of Kenya’s Ministry of Health for the use of its INDICAID COVID-19 Rapid Antigen Test to detect the disease, in turn, enable early isolation, diagnosis and treatment. The lateral flow immunoassay qualitatively identifies SARS-CoV-2 antigens using nasal swab samples and delivers results in 20 minutes. Now available in 33 countries, INDICAID also holds EUA from the FDA and the European CE Mark.

A researcher at Purdue University has developed a quick and cost-effective paper-based Covid-19 test based on a biosensor technology used to identify Bovine Respiratory Disease (BRD) in cattle using nasal swabs. The new test, by agricultural and biological engineering assistant professor Mohit Verma, provides results in 60 minutes with an analytical specificity of 100%. Using saliva, the test can potentially check for different Covid-19 strains simultaneously.

9:28 am

Coronavirus company news summary – Relay Medical creates new system for home and small business testing – Todos Medical’s variant test shows potential in studies

Relay Medical has created a new system based on its Pharmatrac platform to enable home, small business and community testing. The device and mobile app can be used with lateral flow diagnostic kits, including Covid-19 antigen and antibody tests. Relay added that the new cost-effective system leverages FRR’s Fionet cloud-based rapid testing and monitoring platform for more compliant Covid-19 testing.

Todos Medical has reported that its lab Provista Diagnostics concluded the validation studies of the Kogene Biotech PCR Variant Test Kit, which is designed to detect the crucial mutations related to certain SARS-CoV-2 variants, including the P681R mutation found in the Delta variant. The test allows Todos to classify the lineage of the strain associated with a positive Covid-19 test. It delivers results within one hour, which is considered much quicker compared to genome sequencing. These validation studies will support the start of the test kit’s production and its launch next month.

US drugstore chain Rite Aid has partnered with the US Department of Health and Human Services (HHS) and BioReference Laboratories to launch a ‘Back to School’ Covid-19 testing programme in New York State. Students in public schools in the state will have access to RT-PCR lab-based Covid-19 tests before or at the start of the upcoming school year. Digital results will be provided to parents.

9:52 am

Coronavirus company news summary – FDA approves BD’s at-home test for emergency use – UK competition authority warns PCR test providers against breaching law

The US Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for BD‘s Veritor At-Home COVID-19 Test. Veritor is the first rapid antigen at-home Covid-19 test that leverages computer vision technology in a smartphone to read and deliver digital results within 15 minutes. It needs no prescription or laboratory and cuts down the results delivery time. The lateral flow test, which involves a nasal swab and Scanwell Health’s mobile app, can be used for self-testing by people aged 14 years and above.

The UK’s Competition and Markets Authority (CMA) has warned PCR Covid-19 test providers against breaching consumer protection law over misleading advertisements and potential failures to deliver results. In an open letter, the agency said that if customers are misled or not treated fairly, test providers could face enforcement action. The practices of concern noted by CMA include advertising prices that exclude additional charges or tests with limited or no availability, and no refunds for delays of results.

ID Genomics has developed a rapid test that could detect several genetic SARS-CoV-2 variants simultaneously. The company has received a US National Institutes of Health (NIH) grant to fast-track its dipstick-based, field-deployable test to the market. Within two hours, the test can simultaneously ‘fingerprint’ all presently identified variants of concern or interest such as Alpha, Beta, Gamma, Delta, Delta-plus, Epsilon and Lambda. It is also said to have the potential to spot new variants’ emergence. The test will not need any costly instrumentation and can be swiftly rolled out at epidemiological surveillance labs worldwide.

9:57 am

Coronavirus company news summary – Achiko secures approval for emergency use of rapid test in Indonesia – Rako Science to offer saliva test for vulnerable communities in New Zealand

Swiss company Achiko, via its subsidiary PT Achiko Medika Indonesia, has received product and registration emergency use approval for its DNA aptamer-based rapid test, AptameX, for Covid-19 in Indonesia. The Indonesian Ministry of Health has also approved the test’s sister digital passporting service, Teman Sehat (Health Buddy). PT Achiko Medika Indonesia and PT Indofarma TBK have signed an agreement to produce the cost-effective Covid-19 test and obtained product registration approval in the country.

Rako Science has partnered with non-profit organisation Whānau Waipareira to provide its COVID-19 PCR saliva test for vulnerable communities in New Zealand. The test, which was developed by the University of Illinois, will be deployed at Waipareira’s community testing centre to help protect asymptomatic individuals. The saliva test is non-invasive and observed to be at least as precise as nasopharyngeal swab tests in detecting Covid-19.

Healthcare technology firm Medivolve is set to introduce mobile vans for Covid-19 testing in a bid to boost on-site testing for schools, workplaces and events. The mobile testing vans will have the required testing equipment, supplies and technology for patient registration. Meant to enable early detection of the disease, the new service covers rapid antigen and antibody tests, and PCR tests that deliver results in 15 minutes, and two to ten business days, respectively. The first two mobile testing vans will be launched in Las Vegas, Nevada, US.

10:12 am

Coronavirus company news summary – Abingdon introduces BioSURE antibody self-test – QIAGEN receives contract to boost reagents and kits for molecular tests

Abingdon Health has launched the CE marked BioSURE COVID-19 IgG Antibody Self Test, which requires a small drop of finger-prick blood and delivers results within 20 minutes. The test can be used to check and track antibody status before and after vaccination and after Covid-19 infection. Abingdon entered an exclusive manufacturing agreement with BioSure for the test in July this year. BioSure is the legal manufacturer while Abingdon will be the exclusive global producer of the test.

QIAGEN Beverly has received a $0.6m contract from the US Department of Defense (DoD) to boost the production capacity of enzymatic reagents and reagent kits required for Covid-19 molecular diagnostic tests. The reagents manufactured by the company are used to identify SARS-CoV-2 in samples. This expansion will enable the company to grow its per month production of reagent kits by 7,000 and enzymes by 5,100mg at its Beverly, Massachusetts, plant by the end of February next year to support domestic laboratory Covid-19 testing.

Contact tracing startup Traceperts has begun crowdfunding at Indiegogo to support their ‘Super Antigen Test’ Mega Covid Complete, which tests, contact traces and reports to local health authorities. The test leverages the company’s SkyCovid Self Reporting Database Technology. A Covid-19-positive individual can fill out the relevant information on the reporting website. The information, which is sent via the SkyCovid Database Technology, facilitates the local health authority to swiftly plan, mitigate and add to their Covid positive tallies.

10:30 am

Coronavirus company news summary – UK to launch new antibody test programme for positive individuals – Israel introduces antibody tests for children

The UK government is set to launch a nationwide antibody surveillance programme, making free home antibody tests available for up to 8,000 Covid-19-positive people per day. The UK Health Security Agency will provide finger-prick tests to gain more insights into immunity against Covid-19 from vaccination and infection. Individuals aged above 18 years can opt-in to be part of the programme when booking a PCR test for Covid-19 via NHS Test and Trace service.

Diagnostic company LumiraDx has announced that the value of its business combination agreement with special purpose acquisition company (SPAC), CA Healthcare Acquisition, has decreased from $5bn to $3bn. The company cited general market drops in Covid-19 testing volumes and the recent market for publicly trading diagnostic firms as the primary reasons for the revision. Earlier this month, LumiraDx obtained Emergency Use Authorization from the US Food and Drug Administration for its SARS-CoV-2 Ab test.

Israel has rolled out antibody testing for children aged as young as three years to obtain data on the number of youths who did not receive a Covid-19 vaccine but developed protection against the disease through infection. Vaccination of children aged 12 years and older is currently underway in the country. The new serological survey targets about 1.5 million children aged three to 12 years who are currently ineligible for a vaccine. Children found to have adequate antibodies will not be required to quarantine on exposure to a Covid-19 patient, which is intended to limit schoolyear disruptions.

11:40 am

Coronavirus company news summary – Spartan Medical launches Covid support programme for universities – Simple saliva test as reliable as nasopharyngeal swab at detecting Covid-19, study finds

Spartan Medical has launched the COVID-19 Surge Augmentation Support (SAS) Program, a testing service for colleges and universities. The programme involves pop-up tests, licensed medical staff, contact tracers and technology to connect the Antigen Rapid test with confirmatory polymerase chain reaction (PCR) test results for the same person. In addition, the service will integrate daily reports to local and state health departments.

A real-world clinical trial by Beth Israel Deaconess Medical Center (BIDMC) researchers has found that results from Covid-19 tests using self-collected saliva are as reliable as nasopharyngeal swabs, which are the current gold standard for diagnostic testing of the disease. In an outpatient setting, saliva tests could identify 93% of Covid-19 cases. Researchers expect this data to aid in mitigating Covid-19 testing challenges due to shortages of the specialised nasopharyngeal swabs and the burden on the trained medical personnel required to conduct the tests.

Agilent Technologies has announced that researchers at the Indian Institute of Technology Bombay in India and the QIMR Berghofer Medical Research Institute in Australia have leveraged its Agilent Cary 630 FTIR Spectrometer to create a rapid screening approach that distinguishes between Covid-19-positive patients who are likely to develop severe symptoms and those who may develop only mild symptoms. The new method’s classification algorithm uses infrared spectra of blood plasma, acquired on Agilent’s Spectrometer.

10:31 am

Coronavirus company news summary – Turkish universities develop Covid-19 antibody test kit – India’s SCTIMST introduces RT-PCR test for Covid-19 detection

A team of scientists from Inönü and Adıyaman universities in Turkey has developed a Covid-19 antibody test kit. The enzyme-linked immunosorbent assay (ELISA)-based kit provides 95% accurate data on antibody levels after vaccination and will help in determining immunity levels in a community, Daily Sabah reports. The ELISA based kit has already qualified in the Health Ministry’s safety and accuracy tests and is ready for mass production.

The Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) in India has developed a reverse transcription polymerase chain reaction (RT-PCR) kit to facilitate detection of Covid-19. The kit is capable of providing results within two hours, reports The Hindu. The Indian Council of Medical Research (ICMR) validation shows that the kit has 97.3% sensitivity and 100% specificity in novel coronavirus detection. Huwel Lifesciences in Hyderabad has signed an agreement for the commercial supply of the kit.

DNANudge, which manufactures rapid Covid tests, has secured $60m funding in a round led by Ventura Capital. The funding will be used to scale up production and expand diagnostic applications, reports Bloomberg. The company will use the proceeds to produce cartridges for its portable devices that can detect Covid-19 in around an hour. DNANudge also makes cartridges for cancer testing and consumer skincare products.

10:09 am

Coronavirus company news summary – Uni of Birmingham validates new Covid-19 test – Covid viral load not a reliable indicator of transmission risk, study finds

A research team at the University of Birmingham has validated the speed, precision, sensitivity and simplicity of a new test to detect Covid-19 in a three-way comparison study. The test, referred to as reverse transcription-free Exponential Amplification Reaction (RTF-EXPAR), was observed to have similar sensitivity and more speed compared to polymerase chain reaction (PCR) and real-time loop-mediated amplification (LAMP) tests presently used in hospitals. The new test offers a sample-to-signal time of less than ten minutes, including for low viral levels where existing lateral flow tests are reported to be less effective.

A new study by researchers at Tulane University in New Orleans, Louisiana has found that monitoring viral load information among Covid-19 positive individuals is not a reliable indicator of disease transmission risk. The study assessed the reliability of cycle thresholds (Ct) from PCR tests as an indicator of the quantity of virus carried by an infected person. A study published in the Journal of Molecular Diagnostics shows that people with even low viral loads can transmit the virus. Testing and contact tracing in the latest study revealed that Ct value alone could not forecast transmissibility and all contacts of positive patients, including those with low virus levels, must be quarantined.

SpeeDx has launched a new product line of research reagents for Covid-19 variant analysis to add a mutation associated with the SARS-CoV-2 Delta variant of concern (VOC). The new PlexPrime SARS-CoV-2 Genotyping product line uses the company’s universal substrate method and multiplexing technology to detect vital VOCs in positive samples. Part of the new portfolio is PlexPrime SARS-CoV-2 P681R Delta, which is a single well mix to identify the SARS-CoV-2 virus’ P681R spike mutation present in B.1.617.2 (Delta) VOC, as well as an RdRp gene target of the virus.

10:10 am

Coronavirus company news summary – FDA grants EUA to two Thermo Fisher Covid-19 assays – CapeBio to provide domestic Covid-19 PCR test kit production in South Africa

Thermo Fisher Scientific has received Emergency Use Authorization (EUA) from the US Food and Drug Administration for its new TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the TaqPath COVID-19 RNase P Combo Kit 2.0. The assays are designed to offer higher target redundancy to address existing mutations and emerging variants of the SARS-CoV-2 virus, the company said. The PCR Combo and RNase P Combo tests, which target eight genes across three regions of SARS-CoV-2, deliver results in two and three hours, respectively.

South Africa-based biotechnology company CapeBio has received approval from the country’s regulatory authority to manufacture rapid Covid-19 PCR test kits locally. The test kits are jointly developed by the company and the Council for Scientific and Industrial Research (CSIR). Domestic manufacturing is expected to decrease the country’s dependence on imports and enable prompt access to Covid-19 testing. The initial batches of the test kits, being made at the company’s Centurion facilities, are set to reach the market before the end of August. At full capacity, CapeBio will reportedly be able to manufacture up to 5,000 kits per day, and each kit provides for 1,000 tests.

Researchers from the National Institutes of Health (NIH) have created a faster sample preparation technique for the identification of SARS-CoV-2. The new method does not require genetic RNA material extraction, simplifying sample purification and potentially lowering test time and cost. To preserve viral RNA in samples for detection by reverse transcription-quantitative real-time polymerase chain reaction (RT-qPCR), the researchers used a chelating agent developed by lab supply company Bio-Rad. The team assessed nasopharyngeal and saliva samples with different virion concentrations and observed that the specimens can be used to identify RNA directly.

9:43 am

Coronavirus company news summary – CRISPR-based tech could usher in new class of antibody-based diagnostics – UK study highlights ethnic inequalities in Covid-19 hospital admissions

Researchers from Schmidt Science Fellows have unveiled a CRISPR-based technology that could detect antibodies from blood samples, paving the way for medical diagnostics to identify various pathogens, including the SARS-CoV-2 virus. The researchers created a protein self-assembly technique, which can be leveraged to develop new biomaterials and biosensors. In a study, the technology was able to identify antibodies attaching to proteins obtained from pathogens.

A new study led by the University of Birmingham has highlighted the need for new clinical risk management tools to prevent intensive care admissions and deaths of black, Asian and minority ethnic (BAME) patients with Covid-19-related pneumonia. Involving 3,671 patients, the study showed that 81.5% of ethnic minority Covid-19 patients from regions of highest air pollution deprivation were at more risk of hospital admissions versus 46.9% of Caucasians. It was observed that current tools to forecast or measure risk and manage the care of Covid-19-related pneumonia patients are inadequate and may underscore ethnic minority patients.

Medi Lifestyle’s indirect wholly owned subsidiaries, HealthPro Marketing and HealthPro Pharma, have entered exclusive agreements to sell and distribute Lansion Biotechnology’s SARS-CoV-2 Neutralizing Antibodies Test Kit and its LS-4000 Dry Fluorescence Immunoassay Analyser in Malaysia and Singapore. The test kit requires a minimal blood sample that can be placed on a test strip. Subsequently, a lateral flow test delivers a Covid-19 antibody qualitative result in several minutes. The test strip can be run on the LS-4000 Dry Fluorescence Immunoassay Analyser for a detailed quantitative analysis.

9:33 am

Coronavirus company news summary – UK competition authority to investigate PCR tests’ pricing and reliability – DiaCarta wins CE/IVD marking for SARS-CoV-2 variant detection test

The UK’s Competition and Markets Authority (CMA) has started an investigation into the price of polymerase chain reaction (PCR) tests for Covid-19. The Secretary of State for Health and Social Care had raised concerns regarding the cost and reliability of PCR travel tests as well as the quality of the service offered by PCR test firms. The CMA will ask if there are any structural pricing and reliability issues in the PCR test market, whether PCR providers are breaching obligations under consumer law and what immediate actions the government could take.

DiaCarta has received CE/IVD marking for its QuantiVirus SARS-CoV-2 Variant Detection Test, allowing commercialisation in the European Union and other global markets. The multiplex qPCR-based test is designed to identify the SARS-CoV-2 virus and its variants. The company is also seeking US regulatory approval for the test’s emergency use.

A team of researchers led by QIMR Berghofer Medical Research Institute in Australia has created new infrared-based technology to identify patients who are at risk of severe Covid-19. The technology was developed in collaboration with the Indian Institute of Technology, using blood samples from Covid-19 patients in Mumbai, India. The levels of various chemical groups in a sample are measured by infrared spectra. QIMR leveraged artificial intelligence to create an algorithm that can detect chemical groups related to patients who went on to develop severe illness. A small pilot study in India showed the test had 85% accuracy in predicting severe disease in Covid-19 patients.

11:22 am

Coronavirus company news summary – Australia clears SpeeDx’s single-well SARS-CoV-2 test – Quest and eMed launch Covid-19 rapid antigen testing for US employers

SpeeDx has obtained clearance from the Australian Therapeutic Goods Administration for its two-gene PlexPCR SARS-CoV-2 test to identify all presently circulating variants of the virus. The single-well test is developed using a database of more than one million sequences. It combines automated software reporting and SpeeDx PlexPrep liquid handling robotics to enable throughputs of 480 to 1,920 patient samples in eight hours.

Quest Diagnostics has partnered with telehealth provider eMed to facilitate clinician-guided rapid antigen Covid-19 testing for employers to mitigate exposure risk at workplaces in the US. The partners will use the BinaxNOW COVID-19 Ag Card Home Test, a self-test that analyses nasal swabs and delivers results in 15 minutes. A certified guide from eMed will oversee the testing virtually. Employees travelling abroad can use the antigen test during their trip for returning to the US.

Biotech firm Aditxt has collaborated with Great Lakes Medical Laboratory (GLML) to launch AditxtScore for COVID-19, an immune response monitoring tool, in Michigan, US. The new solution is designed to detect a spectrum of biomarkers linked to the infection. It monitors several combinations of antibody and neutralising antibody responses to various antigens, thereby allowing analysis of a person’s immune response against SARS-CoV-2. GLML will offer AditxtScore at its six physical locations and mobile units in the state.

1:34 pm

Coronavirus company news summary – Qiagen and GT Molecular partner on new SARS-CoV-2 detection solution – PHASE Scientific’s antigen test gets FDA nod for emergency use

Qiagen and GT Molecular have partnered to provide a wastewater monitoring solution to lavs across the US and Canada, combining Qiagen’s sample-preparation capabilities and QIAcuity digital polymerase chain reaction (PCR) system with GT Molecular’s digital SARS-CoV-2 Wastewater Surveillance Assay. Launched this month, the solution offers results within two and a half hours.

Cardinal Health has collaborated with Abbott and Quidel to improve access to over-the-counter rapid tests for Covid-19. Through its supply network, Cardinal Health will offer Quidel’s QuickVue At-Home OTC COVID-19 Test and Abbott’s BinaxNOW COVID-19 Antigen Self-Test. These at-home tests expand Cardinal Health’s laboratory products portfolio, which enables personalised testing and surveillance programmes for workplaces, schools and hospitality venues.

PHASE Scientific International has obtained the US Food and Drug Administration’s Emergency Use Authorization for its INDICAID COVID-19 Rapid Antigen Test. Indicated for professional use, the test can qualitatively identify SARS-CoV-2 antigen using anterior nasal swab samples in point of care settings. It holds authorisation as a consumer self-test in certain regions outside of the US, including Hong Kong.

10:09 am

Coronavirus company news summary – New World Development and Prenetics introduce at-home test – Mylab and Hemex Health to create point of care diagnostics

Hong Kong-based New World Development and Prenetics have introduced a rapid at-home Covid-19 test, Circle HealthPod, which delivers results in 20 minutes. Also designed for point-of-care use, the CE-IVD marked device is reusable and comes with single-use capsules. Developed at the University of Oxford, the test requires a lower nasal swab and offers results to the user’s smartphone or directly on the device. Circle HealthPod is indicated for symptomatic and asymptomatic people aged two years and above.

ExThera Medical has secured interim order from the Canadian Health Authority for the use of its Seraph 100 Microbind Affinity Blood Filter to treat Covid-19. The blood purification device is able to lower viral and bacterial loads in the bloodstream. The device has held holds Emergency Use Authorization (EUA) in the US since April last year It was seen to significantly decrease mortality in severe Covid-19 cases in an early clinical study.

Mylab Discovery Solutions has partnered with Hemex Health to create point-of-care diagnostics for Covid-19 and other diseases. Mylab will work on developing fluorescence immunoassay (FIA) and electrophoresis-based test assays while Hemex will offer its Gazelle testing platform and expertise. The portable device and assays are expected to enable testing at any location across various environmental conditions, and with no requirement for sample transport, delivering fast results.

9:39 am

Coronavirus company news summary – Harvard and MIT researchers develop saliva-based test – Qiagen’s portable antigen test gets FDA EUA

BD and CerTest Biotec have received the European CE mark for a molecular test designed to identify Alpha (B.1.1.7), Beta (B.1.351) and Gamma (P.1) SARS-CoV-2 variants. The VIASURE SARS-CoV-2 Variant Real Time PCR Detection Kit can be used with VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit or as a reflex test for variant detection from a positive sample.

A team of researchers at the Wyss Institute for Biologically Inspired Engineering at Harvard University, the Massachusetts Institute of Technology (MIT) and multiple hospitals in the Boston region have developed a saliva-based self-test for the SARS-CoV-2 virus and its variants. The CRISPR-based test is said to be cost-effective and meant for at-home use. Named miSHERLOCK, the diagnostic device offers results that are read and validated using a related smartphone app in one hour.

Qiagen has obtained Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the use of its portable QIAreach SARS CoV-2 Antigen Test. QIAreach can identify SARS-CoV-2 antigens in two to 15 minutes in individuals with active infections. The test is capable of processing approximately 30 swab samples an hour and delivers digital results.

9:22 am

Coronavirus company news summary – CPAP lowers invasive ventilation need in large trial – US FDA grants EUA to two antibody tests

A large non-invasive respiratory support clinical trial, RECOVERY-RS, has found that continuous positive airway pressure (CPAP) lowers the requirement for invasive mechanical ventilation in hospitalised Covid-19 patients with acute respiratory failure. Led by the University of Warwick and Queen’s University Belfast, the National Institute for Health Research (NIHR) backed trial compared three common respiratory interventions in this patient population. While CPAP reduced the chances for invasive ventilation need, high flow nasal oxygenation (HFNO) demonstrated no benefit compared with standard oxygen therapy.

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to LumiraDx’s SARS-CoV-2 Ab test and Ortho Clinical Diagnostics’ qualitative COVID-19 Total N antibody test. LumiraDx test identifies antibodies to SARS-CoV-2 to aid in detecting people with an adaptive immune response to the virus. Meanwhile, Ortho Clinical test identifies immune response or total antibodies to the virus to provide information on a recent or previous Covid-19 infection in patients.

Researchers at the University of California, Berkeley are working on a new diagnostic test that can be quicker and easier to use versus quantitative reverse-transcriptase-polymerase chain reaction (qRT-PCR). The team integrated two different CRISPR enzymes to develop an assay for identifying minor amounts of viral RNA within one hour. The assay is also expected to facilitate fast and cost-effective tests to diagnose various other infectious diseases.

10:23 am

Coronavirus company news summary – Avacta Group begins shipping antigen lateral flow test – Bio-Techne to launch RNAscope technology to detect SARS-CoV-2 in tissues

Avacta Group has begun shipment of its AffiDX SARS-CoV-2 antigen lateral flow test, which uses nasal swabs to deliver results within 20 minutes. The CE marked test is intended for use by professionals in the UK and EU. Avacta selected Calibre Scientific as its first distributor for the test in these regions and is working to collaborate with several other distributors and end-users in Europe, the UK and Asia among other regions.

Bio-Techne, through its brand Advanced Cell Diagnostics, is set to launch RNAscope technology to detect SARS-CoV-2 in fixed tissues. The technology comes with one of the probes that were used as an Analyte Specific Reagent (ASR) in a study specific to the mRNA of Spike protein of the virus. The probe demonstrated efficacy in detecting viral targets in tissues. The ASR is expected to offer a beneficial tool for researchers and pathologists to identify SARS-CoV-2.

Biozek Medical has introduced its Covid-19 Antigen Saliva Rapid test for the detection of all known mutating SARS-CoV-2 variants. The non-invasive test can be administered by a healthcare expert or self-administered, with results obtained within 15 minutes. The test is designed to address “Nasal Swab Fatigue” by offering a saliva-based alternative to nasal and nasopharyngeal swab tests.

9:57 am

Coronavirus company news summary – Facedrive to supply rapid antigen tests in Canada – AMI Health collaborates with LifeSign to offer multiplexed test

Facedrive has commenced a supply, training and collection programme for the Government of Canada’s Covid-19 rapid antigen tests for small and medium-sized organizations. The tests will be distributed in the province of Ontario in a bid to mitigate the spread of the SARS-CoV-2 virus. The company will supply via its partner network, provide pick-up options and equipment for safe disposal of used tests and gather usage information.

BioVaxys Technology has reported that its CoviDTH disposable point-of-care diagnostic tool was demonstrated to be safe and effective for screening T cell-mediated immune response to SARS-CoV-2. CoviDTH is could  be used to help doctors to understand immunogenicity and T-cell immune responses for detection in exposed and vaccinated people.

US-based AMI Health has collaborated with LifeSign to provide a multiplexed Covid-19/Flu A&B test for the coming respiratory season. Available via AMI Expeditionary Healthcare, the LifeSign Status test can be used by testing centres, labs, hospitals, medical offices and clinics globally. The qualitative assay can identify SARS-CoV-2 antigen and influenza A&B antigen simultaneously using nasopharyngeal swabs and delivers results within 15 minutes.

10:26 am

Coronavirus company news summary – Todos Medical acquires Provista to expand Covid-19 testing – Hackensack Meridian researchers create model to predict death risk

Todos Medical has made the final payment for its $10m acquisition of Provista Diagnostics, which runs a diagnostic testing laboratory that currently enables Covid-19 PCR testing. It also has a breast cancer blood test known as Videssa. Todos is now boosting the marketing team of Provista to build on its automated expertise in Covid-19 PCR testing, variant detection and neutralising antibody testing. Furthermore, Todos expects its cPass neutralising antibody test to be useful as new viral variants challenge the vaccines’ efficacy.

Researchers at Hackensack Meridian University Medical Center and Berry Consultants have created a new model to predict the mortality risk within 40 days in hospitalised Covid-19 patients. The model works by considering a patient’s age, respiratory and oxygenation rates and preexisting conditions. It could help doctors make treatment decisions and inform therapeutic strategies.

Increasing Delta SARS-CoV-2 variant cases in the US have increased demand for Recuro Health’s at-home or onsite Covid-19 testing platform, the company said. The platform is designed to facilitate rapid antigen and PCR testing for Covid-19 with immediate results. Recuro has received multiple requests from employers across the US for its testing platform after the new directives were issued.

10:15 am

Coronavirus company news summary – G20 partners with PharmXGen for rapid antigen tests – Siemens raises 2021 financial outlook on Covid-19 test sales

UAE-based company G20 has partnered with US company PharmXGen to exclusively supply and distribute the latter’s Covid-19 rapid antigen tests in the Middle East and North Africa. The intranasal tests can deliver results in three to ten minutes with 100% efficiency. These tests have approvals in the US, UK and Germany, among other countries.

Health services provider Affinity Empowering is set to deploy Covid-19 testing programmes at zero cost in public congregate settings under Operation Expanded Testing (OET), which is an agreement with the US Department of Health and Human Services (HHS). Affinity is managing the OET programme on behalf of Eurofins’ unit Clinical Enterprise. The company noted that the latest move is intended to address the rising Delta SARS-CoV-2 variant cases across the US.

Siemens Healthineers has raised its full-year 2021 guidance based on estimations for sales of rapid Covid-19 antigen tests, which are expected to fetch nearly $1.1bn (€1bn). The company said that revenue from these tests peaked in the third quarter of the fiscal year 2021, reaching approximately $712m (€600m). In addition, free cash flow more than doubled in the quarter to $1bn (€852m), driven by sales of rapid Covid-19 antigen tests.

12:24 pm

Coronavirus company news summary – Menarini launches real-time Covid-19 PCR test kit – eMed partners with Delta to provide Covid-19 tests for returning US travellers

Menarini Diagnostics has introduced a new real-time polymerase chain reaction (PCR) kit, CoronaMelt VAR, an updated version of the CoronaMelt Kit, to detect SARS CoV-2 and screen for Alpha, Beta and Gamma variants. Designed for use on real-time PCR lab instruments, the new kit can concurrently detect any SARS CoV-2 variant and identify the three most common ones from oro/nasopharyngeal swabs. This decreases the unknown samples that have to be assessed using DNA sequencing or reflex real-time PCR genotyping assays, the company said.

Telehealth firm eMed has partnered with Delta Air Lines to facilitate Covid-19 testing for travellers who are planning to return to the US. Customers can buy the BinaxNOW COVID-19 Ag Card Home Test kits at the airline’s website, eMed website or specific Walgreens pharmacy stores. The rapid antigen home test kit does not need any other equipment and is portable for use abroad up to three days before boarding a flight to the US. It delivers results within 15 minutes.

A research team at King’s College London has conducted a large-scale, prospective, epidemiological surveillance study to investigate whether their model using self-reported data could allow early detection of Covid-19. The team analysed the data on 19 symptoms from participants in the UK over three days following the symptoms’ onset and Covid-19 PCR test results from the COVID-19 Symptom Study mobile phone app. According to study findings published in the Lancet, the new model demonstrated feasibility for early identification of Covid-19.

10:00 am

Coronavirus company news summary – 3a-diagnostics identifies biosensor candidates for oral screening – Leaf Space to launch satellite-driven telemedicine tool for monitoring

3a-diagnostics has identified biosensor candidates that can be used for affordable and easy oral screening and quick detection of Covid-19 in real-time. Activated by saliva, the candidates are based on the oral dissolvable delivery platform of XPhyto Therapeutics, which agreed earlier this month to acquire 3a-diagnostics. Apart from Covid-19, the biosensor candidates can be used to detect other infectious diseases in at-home and point-of-care settings.

Qorvo has reported that its Qorvo Omnia SARS-CoV-2 Antigen Test platform was validated in two independent studies performed by the Atlanta’s Center for Microsystems Engineered Point-of-Care Technologies (ACME-POCT) and funded by the National Institutes of Health (NIH). The adult and pediatric studies demonstrated the low SARS-CoV-2 limit of detection as well as high specificity and sensitivity of the test when compared with the Roche cobas 6800 and Hologic Panther RT-PCR systems.

Leaf Space is set to launch a new telemedicine solution via satellite for monitoring of Covid-19 patients at home. The solution is part of the company’s CARES project, which is funded by the European Space Agency. A suite of medical devices linked to a smartphone, CARES captures the vitals of a patient by leveraging medical software and remotely sends those vitals to a database that doctors can directly access from a web browser. The remote platform enables monitoring and care for Covid-19 patients, particularly those who are recovering from the disease.

9:00 am

Coronavirus company news summary – MeMed receives CE mark for test to predict disease severity – iXensor introduces data management platform for antigen test

MeMed has secured the European CE mark for its MeMed COVID-19 Severity test, which uses host response technology to check for various proteins in a serum sample. The test uses machine learning to then predict the risk of severe outcomes in patients with Covid-19. It reads the immune system in real-time to offer precise results within 15 minutes.

iXensor has launched the new PixoHealth Pass Admin App and Web Portal screening solution for Covid-19. The platform is designed for use with the PixoTest POCT COVID-19 Antigen Test, which identifies the main SARS-CoV-2 variants such as Delta, Gamma, Alpha and Beta. The new solution screens and validates the Covid-19 linked health conditions using a QR code scan shown by PixoHealth Pass App users. It simultaneously coordinates relevant health data and rapid test results from the app users and PixoTest POCT Analyzer.

Malaysian telemedicine firm DOC2US has launched the RTKis Rapid Test Kit Intelligent System for testing, recording, management and reporting of Covid-19 cases. The system comprises an RTK antigen test kit for self-testing at home. The test result is validated by artificial intelligence technology on the DOC2US RTKis platform. The system currently works with the Gmate Saliva Antigen Test Kit, which is imported by CityMedics.

10:04 am

Coronavirus company news summary – SpeeDx introduces new research agents for SARS-CoV-2 variants – CityHealth to offer RapidReturn test for travellers

SpeeDx has introduced a new line of research reagents for reflex variant analysis of circulating Covid-19 variants of concern. The PlexPrime SARS-CoV-2 Genotyping research reagents are intended to facilitate the identification and tracking of emerging and circulating variants by detecting specific viral mutations. These tests can be used with traditional quantitative polymerase chain reaction instrumentation.

CityHealth has launched the RapidReturn Kit for Covid-19 testing of US-bound travellers, who can obtain the rapid antigen test results within minutes from any place globally. The cost-effective pre-travel test comes with specialist support to guide travellers on the collection of samples, testing and delivery of results. Each kit consists of two tests, including sterile swabs, test strips and testing solution.

Avricore Health subsidiary HealthTab has added Abbott’s ID NOW molecular testing device to its supplier distribution agreement, which was initially signed in May this year. The device will now be used at HealthTab’s community pharmacy locations for on-site testing and reporting of the SARS-CoV-2 virus. ID NOW is also capable of detecting respiratory syncytial virus, influenza A and B, and Strep.

9:39 am

Coronavirus company news summary – FDA discontinues EUA review of SQI Diagnostics’ triage test – Abingdon Health agrees to produce BioSure’s lateral flow tests

The US Food and Drug Administration (FDA) has stopped its Emergency Use Authorization (EUA) review of SQI Diagnostics’ RALI-Dx IL-6 Severity Triage Test due to a high volume of EUA requests and its prioritisation of reviews. The regulator asked SQI to seek a non-EUA regulatory clearance for the test, which is designed to detect patients having severe inflammatory responses caused by Covid-19 or any other source of respiratory distress.

Abingdon Health has entered an exclusive agreement to produce BioSure‘s lateral flow tests (LFTs) for Covid-19. The terms of the deal involve Abingdon’s York and Doncaster plants’ lateral flow manufacturing facilities. These tests will be supplied to the UK and global markets. Financial details of the agreement were not disclosed.

BD has secured EUA from the FDA for its Vacutainer Plus Citrate Plasma Tubes (UK manufacturing site). This tube is indicated for use in emergency settings to obtain, transport and store blood samples for coagulation testing. The device is expected to facilitate the detection and treatment of coagulopathy in patients with known or suspected Covid-19 among other conditions.

9:35 am

Coronavirus company news summary – VolitionRx’s Nu.Q NETs assay shows promise in risk stratification – Japan allows BioIQ to conduct testing for Tokyo Olympics

Bacter Scientific has developed a hand-held Covid-19 and virus test unit, called Novi, for the detection of SARS-CoV-2 variants. The portable Novi unit uses loop-mediated isothermal amplification-based technology to quickly provide testing results within minutes. It involves disposable tubes to analyse saliva samples for various respiratory viruses and their variants, including Covid-19, Zika and Influenza.

VolitionRx has reported favourable results from two Covid-19 studies conducted in partnership with researchers at two NHS Foundation Trusts to assess the use of its blood test, Nu.Q. According to early-stage data, the assay results on admission can potentially forecast future Covid-19 severity while serial results are linked to disease progression. With a neutrophil extracellular traps (NETs) component, the assay could have broad applicability to track various diseases such as Covid-19, sepsis and cancer, the company said.

The Government of Japan has approved BioIQ to enable Covid-19 testing for athletes and staff visiting Japan for the Tokyo Olympics. The company is using saliva-based RT-PCR tests and molecular tests for on-site testing events at its headquarters and local personnel locations globally. BioIQ noted that thousands of personnel will be tested several times and must deliver negative Covid-19 results before travelling to Japan.

9:49 am

Coronavirus company news summary – PathogenDx obtains CE mark for microarray assay – IIT Bombay researchers develop test for disease severity

PathogenDx has obtained the CE-IVD mark allowing the sale and supply of its DetectX-Rv Microarray Assay for Covid-19 in Europe. The test is designed to identify SARS-CoV2 within three hours following RNA extraction using nasopharyngeal swabs and nasal aspirate or fluid. DetectX-Rv, which could analyse several samples simultaneously, has a 100% specificity. It also holds Emergency Use Authorization (EUA) in the US.

A research team led by the Indian Institute of Technology Bombay has developed a blood test to identify Covid-19 patients who can potentially develop serious symptoms. The test is expected to aid hospital triage by enabling healthcare workers to prioritise patients for hospital and intensive care admission. It leverages the attenuated total reflectance Fourier transform infrared spectroscopy (ATR-FTIR) method to measure changes that severe Covid-19 causes in blood biochemistry.

China-based Joysbio has reported that its rapid Covid-19 antigen test showed the ability to identify new SARS-CoV-2 variants, including the Delta (B.1.617.2), Alpha (B.1.1.7), Gamma (P.1) and Beta (B.1.351) variants. A clinical analysis of 492 samples in Italy demonstrated a 98.13% sensitivity and 99.22% specificity with the test, which delivers results in 30 minutes. More than 100 million kits of the test have been sold in Europe for personal and professional application.

10:12 am

Coronavirus company news summary – Enzo Biochem gets EUA for rapid extraction on Covid-19 test system – Quest Diagnostics and CLX Health partner on live event testing

Enzo Biochem has obtained US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a rapid extraction method on its AMPIPROBE test system to identify SARS-CoV-2, including genetic variants. The new extraction method will allow laboratories to cut the time by one hour or about 25%, in turn facilitating more tests on one instrument.

Chembio Diagnostics has secured a $28.3m purchase order from Bio-Manguinhos for its DPP SARS-CoV-2 Antigen test to be delivered this year for Covid-19 testing in Brazil. The test, which can potentially identify the SARS-CoV-2 antigen from a nasal swab and deliver results in 20 minutes, is expected to help control the spread of Covid-19 in the country.

Quest Diagnostics has partnered with CLX Health, which operates the TrustAssure Testing Platform, to offer Covid-19 molecular diagnostic tests for individuals attending live events in the US or travelling internationally. People can use TrustAssure to schedule appointments for testing at certain Quest Diagnostics patient service centres and more than 750 retail partner pharmacy sites across the country. Test results will be delivered in 48 hours.

9:22 am

Coronavirus company news summary – Cambridge University researchers to develop test for long Covid – Todos Medical partners with Fosun Pharma to launch cPass kit

Researchers at the University of Cambridge and Cambridge University Hospital NHS Foundation Trust have identified biological ‘fingerprints’ in the blood that can be used to potentially detect Covid-19, even several months after asymptomatic or mild infection. The findings can allow the development of a test to diagnose long Covid. This project, which is supported by the National Institute for Health Research funding, will use similar biological signatures to create another diagnostic test to complement current antibody tests for the disease.

Todos Medical has signed a distribution agreement with Fosun Pharma to launch its cPass SARS-CoV-2 Neutralizing Antibody Detection Kit, which is authorised by the US Food and Drug Administration under Emergency Use Authorization (EUA) to identify SARS-CoV-2 neutralising antibodies. Currently, the test is being automated to enable high-capacity testing and quick turnaround times. Todos will provide cPass as a testing service through its Provista Diagnostics laboratory as well as supply kits to client labs.

Quidel has collaborated with the state of Delaware, US, to deploy a full-service Covid-19 testing programme at schools via its new service provider, Quidel Services. The company will use its rapid antigen tests to screen students and faculty who opt-in to the initiative. Additionally, Quidel will staff test sites, manage sample collection, run the tests and report results to the Delaware Division of Public Health and the participating schools and school districts to facilitate screening for asymptomatic Covid-19 cases.

9:18 am

Coronavirus company news summary – UK launches research programme for long Covid diagnosis – Trinity Biotech advances development of SARS-CoV-2 antigen test

The UK government has launched a research programme focused on the diagnosis and treatment of long Covid. With the support of £19.6m, the programme will involve 15 new research studies to support the vulnerable population. As part of the project, University College London will conduct a long Covid trial to examine MRI scans as a diagnostic tool for potential organ damage. The trial will also test for improved rehabilitation via an app for symptom checking and to evaluate current drugs as potential treatments.

NG Biotech has unveiled its new Ninonasal COVID-19 antigen self-test to identify the Delta and Epsilon variants of Covid-19 using nasal samples. The test, which delivers results within minutes, can also detect Alpha, Beta and Gamma variants of SARS-CoV-2. Ninonasal has secured the European CE mark after showing the ability to clinically identify the critical variants of concerns in hospitals in the region.

Trinity Biotech is advancing the development of a Covid-19 rapid antigen test based on its lateral flow technology. Designed to run without any specific instruments, the test offers results in 12 minutes after analysing an anterior nasal swab sample. Trinity Biotech, which also provides an HIV detection test, anticipates the continued use of antigen testing as part of the overall public health response to the Covid-19 pandemic.

10:12 am

Coronavirus company news summary – IIT-Hyderabad researchers develop AI-based test kit – Accure Health’s saliva assay monitors response to vaccines

SQI Diagnostics has partnered with AZOVA for the sale and supply of its COVID-19 HOME Antibody Test to its customers in airlines, wholesale clubs, retail pharmacies, grocery chains, US state and international governments, school districts and universities. The agreement is contingent on US Food and Drug Administration (FDA) approval. In regions that authorised the distribution of SQI’s test, consumers will have access via AZOVA’s online digital health platform. The test can identify IgG, IgA and IgM immune responses to the SARS-CoV-2 virus.

Researchers at the Indian Institute of Technology, Hyderabad (IIT-H) have developed an artificial intelligence (AI)-based RNA test kit to detect Covid-19 at home. The electronic test, named Covihome, is pending approval. The researchers claim it can deliver results in under 30 minutes for symptomatic and asymptomatic individuals. In an independent analysis by the Centre for Cellular And Molecular Biology, the test had an efficiency of 94.2%, sensitivity of 91.3% and specificity of 98.2%. Mass manufacturing of the AI-based Covid-19 test is expected to decrease its price.

Accure Health has reported initial findings from a proof-of-concept study, which demonstrated that its new saliva assay can evaluate the immune response to each Covid-19 vaccine, track neutralising antibody levels and model immune protection against the virus variants. In the study of 111 subjects, the TiMES-Now assay showed better performance compared with standard blood tests in multiple important measures. The new assay was 100 times more sensitive than enzyme-linked immunosorbent assay, as well as quicker and cost-effective versus traditional blood-based tests.

11:01 am

Coronavirus company news summary – Intelligent Fingerprinting creates saliva-based test – Cue Health gets approval for point-of-care test in India

Intelligent Fingerprinting has created a saliva-based lateral flow test (LFT) to quickly identify Covid-19 antigens. Current tests for Covid-19 involve the invasive nose and throat swabs but the new test requires a swab of a saliva sample from inside the cheek, making testing easier for all ages, the company said. The test strip has a simple design with minimal plastic use. Meant to enable regular testing even in public spaces such as schools and airports, the new test provides results in 20 minutes.

Cue Health has obtained approval from India’s Central Drugs Standard Control Organisation (CDSCO) for professional use of its point-of-care Covid-19 test. The portable test is designed to deliver results to linked mobile smart devices in approximately 20 minutes. It can also detect emerging variants of the Covid-19 virus. Cue’s digital platform facilitates end-to-end integrated reporting of results. The test already received authorisation in the US, EU and Canada.

Hologic has secured the European CE mark to use saliva samples with its Aptima SARS-CoV-2 assay, a molecular diagnostic test to identify the genetic material from the Covid-19 virus. Run on the automated Panther system, the assay holds CE mark for nasopharyngeal and nasal swabs usage among other types of specimens. The company boosted production capacity to make Aptima tests in large volumes, with more than 100 million of these tests shipped globally since last year.

10:07 am

Coronavirus company news summary – UK opens first megalab to boost Covid-19 test and trace capacity – GT Molecular unveils PCR tests for Delta variant and Influenza A and B

The UK’s first testing megalab, the Rosalind Franklin Laboratory in Royal Leamington Spa, has opened. The lab will be processing and sequencing thousands of Covid-19 tests every week in an effort to respond to new variants and disease threats in the future. The opening is also expected to create 1,500 skilled jobs for the region. The laboratory is part of the UK’s NHS Test and Trace network, which will be using cutting-edge technology to process more tests and adopt the new genotype assay testing to quickly identify variants and new mutations.

GT Molecular has begun shipping its highly sensitive PCR tests to identify the Covid-19 Delta variant (B.1.617.2), which was first identified in India in December 2020. In addition to SARS-CoV-2 variants, GT molecular tests also detect influenza A and B, helping researchers and policymakers to accurately assess community pathogen levels and make precise data-driven decisions. The company is also offering additional RT-qPCR kits to screen the Gamma, Epsilon, Beta and Alpha variants.

Global WholeHealth Partners (GWHP) has confirmed that its antibody and antigen test kits are able to detect mutated Covid-19 strains.

10:09 am

Coronavirus company news summary – Abbott launches Panbio Covid-19 antigen self-test in India – FluroTest files pre-emergency use authorisation with FDA

Abbott has announced the launch of its Panbio Covid-19 antigen self-test in India. According to the current Indian Council of Medical Research (ICMR) advisory on self-use, these tests will be available to enhance testing of symptomatic and asymptomatic individuals and contacts of confirmed Covid-19 cases. The Panbio test has also received a CE Mark for over-the-counter use in adults and children, with or without symptoms. It is a minimally invasive nasal swab test that delivers results in just 15 minutes and correctly identifies 95.2% of the positive samples and 100% of negative samples.

Quidel Corporation has received the CE Mark for its Savanna multiplex molecular analyser and Savanna RVP4 assay. The CE Mark allows Quidel to commercialise its Savanna system across Europe, as well as other countries accepting the CE Mark. Savanna allows professionals to analyse up to 12 pathogens or targets, plus controls, from a single assay run in less than 30 minutes. Its initial Savanna RVP4 assay is a rapid, multiplexed nucleic acid test that helps in detecting and differentiating between influenza A, influenza B, respiratory syncytial virus (RSV) and SARS-CoV-2 RNA from nasal or nasopharyngeal swabs.

FluroTech and its wholly-owned subsidiary FluroTest Diagnostic Systems have filed a pre-Emergency Use Authorization (Pre-EUA) request with the US Food and Drug Administration (FDA). The Pre-EUA submission is the company’s latest step in seeking authorisation of its FluroTest pandemic response platform, which is designed to improve widespread access and scale to SARS-CoV-2 testing by leveraging robotics automation, fluorescence detection, biochemistry and cloud computing.