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

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.

9:54 am

Coronavirus company news summary – FDA to authorise Ortho Clinical Diagnostics’ Covid-19 IgG antibody test – QuantuMDx launches Q-POC rapid point of care diagnostic system

Ortho Clinical Diagnostics has announced that its VITROS anti-SARS-CoV-2 IgG quantitative test is the first quantitative Covid-19 IgG antibody test to receive Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). Ortho’s new quantitative test targets the S1 spike protein to identify individuals with an adaptive immune response to the SARS-CoV-2 virus. It provides 100% specificity and sensitivity.

QuantuMDx Group, a UK-based point-of-care diagnostics developer, has announced the launch of Q-POC, a rapid, PCR point-of-care diagnostic system. QuantuMDx’s Q-POC system and its SARS-CoV-2 detection assay are now CE-IVD marked under the In Vitro Diagnostics Directive (98/79/EC). The Q-POC SARS-CoV-2 assay has been examined at St George’s, University of London, to measure clinical performance against tests in current use. The Development and Assessment of Rapid Technology (DART) study has found 96.9% sensitivity, 98.3% specificity, and 0% cross-reactivity with common commensal or potentially interfering organisms.

Researchers at RMIT University have collaborated with partners, including the Australian biomedical start-up Soterius, to develop an instant biosensor that can detect the SARS-CoV-2 virus and its variants. The non-invasive Soterius Scout sensor delivers results in just a minute, thereby helping frontline workers and the wider community by alerting them to undertake a Covid-19 test and self-isolate if required. A prototype is being developed further by Soterius in partnership with RMIT, the Burnet Institute, MIP Diagnostics and D+I and Vestech, and is expected to be released in early 2022. The technology will be manufactured in Australia and will be delivered to hospitals first, with future applications in other settings including aged care, airports, quarantine hotels and schools.

9:28 am

Coronavirus company news summary – Pharmed and MyBio make Covid-19 rapid antigen self-test available in Ireland – LightDeck Diagnostics awarded $35.1m for Covid-19 tests

MyBio, Irish-based life sciences company, has partnered with Pharmed, a pharmacies supplier in the UK and Ireland, to bring an accurate and convenient Covid-19 rapid antigen self-test to their pharmacies nationwide. The MP Biomedicals Covid-19 Rapid Antigen self-test is the first European produced, an EU-certified rapid antigen self-test that delivers results in just 15 mins with 98.72% accuracy. The test is expected to curb the spread of the Delta variant in Ireland and will also enable them to issue EU digital travel certificates to customers.

Global WholeHealth Partners, a biotechnology company offering in vitro diagnostic point-of-care tests, says the antibody IgG/IgM tests it offers are capable of detecting all the SARS-CoV-2 variants. The Alpha, Beta and Gamma strains contain multiple mutations, most prevalent in the S gene, which encodes the spike protein. Global WholeHealth Partners also says its tests reveal quicker results and can be reviewed more quickly by frontline healthcare workers.

The US Department of Defence (DOD), on behalf and in coordination with the Department of Health and Human Services (HHS), has awarded a $35.1m contract to LightDeck Diagnostics, a biotechnology company offering low-cost diagnostic tests, to increase the manufacturing of its upcoming ultra-rapid Covid-19 Ultra-Rapid Antigen and Total Antibody tests. LightDeck will utilise the funds to increase its Colorado-based production capacity, from 50,000 tests per month to one million per month by September 2022.

10:05 am

Coronavirus company news summary – LFTs highly effective in detecting Delta and other variants – UK offers genomic sequencing support to Pakistan

Three studies into the real-world use of rapid tests, known as lateral flow tests (LFTs), have confirmed their effectiveness in a variety of conditions. The three research papers assessed the use of LFTs in a variety of situations: against variants of concern, testing patients with high viral loads, as part of mass testing campaigns, with inexperienced users and using different types of swabs. LFTs were found to be particularly effective in detecting the Delta variant. Accuracy of the tests remained high whether used by an experienced or inexperienced user.

The UK government has announced a new package of genomic sequencing support to help Pakistan fight new Covid-19 variants. With the help of the new variant assessment platform (NVAP) programme, Pakistan will now be able to access expertise and support from the UK in quickly detecting new Covid-19 variants. The UK is considered to be a world leader in genomic sequencing for Covid-19 variants and the second-largest contributor to the international database of variants. The agreement was reached between UK’s Public Health England (PHE) and Pakistan’s National Institute for Health (NIH) to offer reagents to increase genomic sequencing capacity in Pakistan.

The American Association for Clinical Chemistry (AACC) has issued new guidelines to the public advising against the use of cycle threshold (CT) values to guide Covid-19 treatment or public health efforts. According to the AACC, there are many limitations associated with reporting CT values, and may not be helpful in detecting disease severity or transmissibility. Even though CT values correlate with the amount of virus in specimens, they may not actually determine a patient’s overall viral load or infectiousness. AACC’s statement lists a number of factors that can impact the CT values, such as age and sampling instruments used.

10:24 am

Coronavirus company news summary – Psomagen offers direct-to-consumer saliva collection test kits – BiologyWorks to develop SARS-CoV-2 fast molecular reusable diagnostic test

Psomagen is expanding its SARS-CoV-2 diagnostic services to include at-home saliva collection kits. Apart from its GutBiome and Gene Trait testing, the company now offers direct-to-consumer saliva collection test kits for identifying Covid-19 in adults aged 18 and older. The test results arrive 24 hours after the saliva samples are evaluated in Psomagen’s laboratories.

The San Francisco International Airport is expected to launch a free Covid-19 testing programme for international travellers through a pilot programme with the California Department of Public Health. The voluntary programme is expected to offer free testing kits to passengers on their arrival, the first to be administered on the day of arrival and the second PCR test kit to be administered in three to five days. This is the first such initiative in the country, which aims to help the state’s department of public health to monitor Covid-19 variants and create mitigation strategies.

BiologyWorks has received (ISO) 13485:2016 certification to develop its fast molecular diagnostic test, the BiologyWorks k(now) test, which will enable the qualitative detection of pathogens and molecular biomarkers for SARS-CoV-2 and other viruses and infections. The ISO 13485:2016 certification is usually granted to companies that have quality management systems, which consistently meet customer and regulatory requirements.

10:40 am

Coronavirus company news summary – Free Covid-19 tests available in Taipei – Test kits provided to Taal evacuation sites

The Taipei government is offering free Covid-19 polymerase chain reaction (PCR) tests at seven hospitals through online appointments. The government is hoping to curb the spread of coronavirus by offering the tests for free, with the public asked to make online appointments to get the tests to control the flow of patients and ensure social distancing.

The Phuong Trang Group (FUTA Group) in Vietnam has donated more than 50,000 Covid-19 test kits to the Lam Dong Center for Disease Control to curb the spread of Covid-19. The tests were imported from Korea and will be allocated to isolation areas and other regions.

The government of the Philippines has supplied antigen test kits to people affected by the eruption of Taal Volcano. A total of 3,430 individuals are staying at 95 evacuation centres due to the eruption. The test kits will help in preventing infections among the evacuees.

10:26 am

Coronavirus company news summary – New Covid-19 vaccine testing facilities set up in Pune and Hyderabad – GG56 offers Covid-19 digital pass solution for free

Two new Covid-19 vaccine testing facilities have been set up in Pune and Hyderabad, India, financed by the PM-CARES Fund. The new facilities are expected to test vaccines for Covid-19 and other diseases, according to demand, and will test about 60 batches of vaccines per month. The Department of Biotechnology had set up these two vaccine testing facilities in the National Centre for Cell Science in Pune and the National Institute of Animal Biotechnology in Hyderabad, the Ministry of Science & Technology stated.

GG56, a South Korean blockchain company, has opened the source code and intellectual property rights of its mobile digital pass solution, Pass&Go. The blockchain based platform issues temporary digital passes for users based on Covid-19 vaccination, test or prior infection status.

Eurofins, a testing laboratories company, has rapidly developed a broad network of approximately 500 Covid-19 testing centres across Europe and is also looking to establish about 1,000 testing centres by early July. The Covid-19 testing centres cover major travel hubs and provide testing access across many locations including business parks, supermarkets and residential areas, thereby improving people’s proximity to easy and quick testing.

10:04 am

Coronavirus company news summary – FDA grants EUA to BioGX’s Covid-19 RT-PCR test – Alaska Airlines and AZOVA partner to offer Covid-19 home tests

BioGX has sought Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its Xfree Covid-19 test. The test is lyophilised in a single tube for extraction-free, direct sample addition real-time RT-PCR testing. It thereby removes all sample processing steps and enables clinical laboratories to generate high-throughput sample-to-answer results using real-time PCR platforms.

LumiraDx has achieved a CE mark for its RNA STAR Complete SARS-CoV-2 test. The test was initially granted EUA by the US FDA in October 2020 and re-issued the same in March 2021. The LumiraDx RNA STAR Complete SARS-CoV-2 test enables laboratories to quickly adopt and support their testing programmes inside and outside, such as mobile lab units that offer easy access to testing wherever required.

AZOVA, a digital health technology system, and Ellume, a medical technology manufacturer, have entered into a partnership with Alaska Airlines to offer a convenient, at-home rapid testing solution for its travellers. The Ellume Covid-19 home test and AZOVA video observation service allow Alaska Airlines travellers to test themselves and receive accurate results, while at the same time sharing the test results and vaccination status via their smartphone.

10:05 am

Coronavirus company news summary – Vivera, Areum and Access Bio partner to expand Covid-19 rapid tests – XPhyto to supply Covid-19 PCR test to ten Berlin centres

Vivera Pharmaceuticals and diagnostic testing distributor Areum Bio have announced their channel partnership to expand the distribution of Access Bio’s CareStart Covid-19 rapid antigen test and other products granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA). Areum already distributes the CareStart test, and will seek to strengthen its supply chain efforts for rapid tests expansion and accessibility with Vivera’s extensive network.

XPhyto Therapeutics has entered into a master supply agreement with Beovita GmbH & Co. KG and Tackleberries GmbH, two German diagnostics, testing, and medical logistics companies that operate ten Covid-19 test centres in Berlin, Germany. The test will be offered to consumers as a rapid PCR test with sample collection and processing on site. Commercial operations are scheduled to begin once the test kits are delivered.

SpeeDx, a molecular diagnostic solutions company, and MolGen, an industrial automation firm, have agreed to collaborate on the supply and distribution of clinical diagnostics products and instrumentation across the Asia Pacific and Europe. The partnership aims to combine MolGen liquid handling and purpose-built automation with SpeeDx Covid-19 diagnostic solutions to extend a full workflow offering to pathology laboratories.

10:17 am

Coronavirus company news summary – Novacyt launches two new lateral flow tests – BGI and Advaite partner on Covid-19 diagnostic solutions

Novacyt is scheduled to launch two PathFlow Covid-19 antigen lateral flow tests (LFTs), strengthening the company’s Covid-19 testing portfolio and expanding its footing in point-of-care solutions. The company is expected to initially target private market opportunities for these LFTs through its own distribution network. The new PathFlow Covid-19 antigen tests are small, instrument-free and enable safe sample collection, testing, reading and disposal by healthcare professionals or patients at their homes.

Avacta Group, a diagnostics and innovative cancer therapies developer, announced that a study found its AffiDX® antigen lateral flow test can successfully detect the Delta variant in clinical Covid-19 samples. This test also seemed to beat two other lateral flow antigen tests that are commercially available in Europe. Clinical data for Avacta’s test found it to have 100% sensitivity in detecting infectious individuals with viral loads of Ct<27 via a PCR test, where patients are considered to be contagious.

BGI Americas, a diagnostic testing solutions provider, has entered into a partnership with Advaite, a biotech company, and announced the launch of, a hub for diagnostics companies looking for partnerships based on licensing, distribution agreements and original equipment manufacturers. The partnership is expected to add Advaite’s RapCov rapid Covid-19 test to BGI’s portfolio of diagnostic testing solutions and combine Advaite’s handheld test with its real-time fluorescent RT-PCR kit for detecting SARS-CoV-2.

10:18 am

Coronavirus company news summary – Abbott’s Panbio rapid antigen self-test receives CE mark – Meridian resubmits EUA application for Revogene SARS-CoV-2 molecular assay

Abbott has received a CE Mark for its Panbio Covid-19 antigen self-test, which allows the company to directly sell the product to consumers throughout Europe. The is designed to detect the SARS-CoV-2 virus in adults and children suffering with or without symptoms. The over-the-counter approval is expected to speed access to safe and reliable Covid-19 self-testing.

Avellino Lab USA, a molecular diagnostics company, announced that more than two million of its AvellinoCoV2 tests have now been performed in the US. It was one of the first tests to receive an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) March 2020. The test offered much-needed capacity during the early days of the pandemic in the country, particularly in nursing facilities, government municipalities, schools, and colleges. The AvellinoCoV2 test targets the N-gene region of the SARS-CoV-2 virus, which is less prone to mutations seen in Covid-19 variants, thereby helping to prevent false negatives.

Meridian Bioscience, a global diagnostic testing solutions provider, announced that it has re-submitted an Emergency Use Authorisation (EUA) application to the US FDA for its SARS-CoV-2 molecular diagnostic test on the Revogene platform. On 22 February 2021, Meridian had voluntarily withdrawn its EUA application to conduct additional research based on FDA guidance. Meridian completed its additional studies and re-applied for EUA on 25 June 2021.

9:59 am

Coronavirus company news summary – IIT Delhi develops a new rapid Covid-19 antigen test kit – Duke University unveils multiple Covid-19 antibodies test

Indian Minister of State for Education Shri Sanjay Dhotre unveiled a new rapid Covid-19 antigen test kit developed by the Indian Institute of Technology Delhi on 25 June 2021. The test kit has been created by a team led by Dr Harpal Singh, professor at the Institute’s Centre for Biomedical Engineering. Available for just Rs 50, the test is expected to produce results in five minutes via an in vitro detection of the virus through nasal and throat swabs and deep sputum samples. The test kit has been approved by the Indian Council of Medical Research.

Biomedical engineers from Duke University have demonstrated that a tablet-sized device can detect multiple Covid-19 antibodies and biomarkers simultaneously. Initial results showed that the test can differentiate between antibodies against the SARS-CoV-2 virus and four other coronaviruses with 100% accuracy. The researchers are now working on determining whether the easy-to-use, point-of-care device can predict the severity of Covid-19 infection, as well as an individual’s immunity against its variants.

Residents of certain blocks in the Bukit Merah and Redhill areas of Singapore are expected to collect antigen rapid test kits at their nearest Residents’ Committee Centre, as part of Ministry of Health efforts to curb community transmission in these areas. The MOH stated that apart from conducting special testing operations in the area, it is also investigating multiple Covid-19 cases, as well as visitors in the vicinity, along with deploying wastewater testing in the area.

9:46 am

Coronavirus company news summary – LumiraDx high sensitivity test detects variants of concern – Mexico authorises Sorrento’s COVI-STIX test and product import license

LumiraDx, a next-generation point of care diagnostics testing company, announced that the LumiraDx SARS-CoV-2 Ag test has the capability of detecting major SARS-CoV-2 variants of concern, including the Alpha, Beta, Gamma, Delta and Epsilon variants. Unlike the routine RT-PCR tests, the LumiraDx test uses antibodies, not nucleic acid based-primers, to detect the SARS-CoV-2 nucleocapsid antigen, rather than the spike protein.

Sorrento Therapeutics, a clinical-stage biopharmaceutical company, has received Emergency Use Authorisation (EUA) and a and product import licence from Mexico’s COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios). The firm is now setting up its Sorrento Mexico Ltd subsidiary in Mexico. It will manage the commercial operations of its COVI-STIX test and other Covid-19 related products in Mexico. The company also plans to ship the first batch of test orders in July 2021. The COVI-STIX test is a rapid, sensitive, 15-minute test that detects the SARS-CoV-2 virus nucleocapsid antigen in nasal or nasopharyngeal samples of infected patients.

Haven Testing, an at-home medical testing services provider, is making the BTNX Rapid Response Covid-19 antigen rapid tests kit available for home use in the Ontario region. The test kit has been authorised by Health Canada and can detect the SARS-CoV-2 virus in just 15 minutes.

9:55 am

Coronavirus company news summary – 221b Foundation helps scale global access to Covid-19 diagnostics – CO2 monitors to prevent Covid-19 transmissions indoors

The 221b Foundation, a non-profit organisation established by biotechnology company Sherlock Biosciences, is entering into multiple partnerships to increase Covid-19 diagnostic manufacturing capacity to ten million tests per month by the end of 2021. The organisation has entered into agreements with ALBOT Technologies, LogicInk, Cooper International, United PPE, Rokline and binx health to develop and distribute diagnostic solutions in India, the UAE, Singapore and the US.

NHS Test and Trace is working along the local authority in Wakefield, England, to bring additional testing and genomic sequencing to the area. Surge testing is expected to begin on 24 June in Wakefield North, Wakefield East, Wakefield South, Pontefract North and Pontefract South, after a small number of confirmed Delta variant (B.1.617.2) cases were identified. All the positive cases have been instructed to self-isolate and their close contacts have been traced. All individuals aged 18 and above live or work in these areas have been requested to get tested whether showing symptoms or not.

Chilean researchers have repurposed a carbon dioxide detector model to warn of the risk of contracting Covid-19 in enclosed areas, reports Reuters. The prototype measures air pollution which, in a room filled with people, would include SARS-CoV-2 if anyone was infected since it is known to circulate via exhaled vapor. The device is not yet commercially available for sale but is expected to upload data to the cloud and thereby issue an audio alert in case of insufficient ventilation that could result in Covid-19 transmissions. Developed by the University of Chile’s Centre for Mathematical Modelling and Centre of Excellence in Astrophysics and Technologies Related, the monitor is currently being tested on university campuses.

9:35 am

Coronavirus company news summary – LetsGetChecked and Illumina collaborate to track Covid-19 variants – J Mitra and Company unveils the Elisa antigen test kit in India

LetsGetChecked has collaborated with biotechnology company Illumina and the California Department of Public Health’s SARS-CoV-2 Whole Genome Sequencing Initiative COVIDNet to identify and trace Covid-19 variants within the US. LetsGetChecked is expected to use its laboratory in Monrovia, California and the Illumina NovaSeq 6000 System, a next-generation sequencing (NGS) platform, to help surveillance projects detect the SARS-CoV-2 virus and its variants.

BioReference Laboratories has announced a Covid-19 testing programme for US-based crew members and guests who travel with the Royal Caribbean Group. Unvaccinated guests will undergo rapid, point-of-care PCR Covid-19 testing prior to boarding their cruise ships. These guests will also be tested on arrival or at the end of their voyage before leaving the ship. Testing procedures can also happen onboard if the voyages are lengthy. All crew members are expected to be routinely tested at regular intervals.

J Mitra and Company, an in-vitro diagnostics kits manufacturer, announced the launch of the Covid-19 Ag Microlisa Elisa test kit in India. The kit is expected to bring down the overall cost of testing and has been approved by the Indian Council of Medical Research (ICMR) and the Drugs Controller General of India (DCGI). It is also expected to provide better efficiencies, thereby reducing the turn-around time between testing and results to just two hours.

10:07 am

Coronavirus company news summary – Avacta signs distribution agreement for SARS-CoV-2 antigen lateral flow test – Bio-Rad unveils new kit for Covid-19 wastewater testing

Avacta Group, a biotechnology company dealing in diagnostics and cancer therapies, has entered into a non-exclusive distribution agreement with Calibre Scientific, a global provider of life science products, to distribute and sell Avacta’s AffiDX SARS-CoV-2 antigen lateral flow test in the UK and European Economic Area (EEA). The test will be available on Calibre’s website and can be purchased by professional users only.

Bio-Rad Laboratories has announced the launch of its PREvalence ddPCR SARS-CoV-2 wastewater quantification kit, an accurate, sensitive and cost-effective tool for the detection of the SARS-CoV-2 infection in community wastewater. The assay helps a community to determine if the virus has been present days to weeks ahead before it is detected among individuals.

GenScript Biotech Corporation and Duke-NUS Medical School have announced that a notice of allowance for the patent application for a novel Surrogate Virus Neutralisation Technology (sVNT) has been issued by the US Patent and Trade Office. Neutralising antibodies have been scientifically proven to prevent the SARS-CoV-2 infection by blocking the virus from infecting human cells, and the test can be used to assess immunity to multiple coronaviruses including SARS-CoV-2.

9:42 am

Coronavirus company news summary – CSIR and Tata group partner to enhance Covid-19 testing in India – Co-Diagnostics’ direct saliva Covid-19 test obtains CE mark

The Indian Council of Scientific and Industrial Research (CSIR) and Tata MD have collaborated to enhance access to Covid-19 testing in tier II and III towns as well as rural areas across India. The move aims to manage any future Covid-19 surge and testing requirements. As per the agreement, CSIR’s network of labs will be used to increase capacity to remote areas, while the RT-PCR CRISPR test will be conducted using the Tata MD CHECK SARS-CoV-2 test kits.

Co-Diagnostics has announced that its Logix Smart SARS-CoV-2 DS (direct saliva) test has sought regulatory authorisation to be sold as an in vitro diagnostic (IVD) for Covid-19 diagnosis in countries that accept the CE mark. The company also announced that the test is being sold from its Utah-based certified facility. The test eliminates RNA extraction of the samples, which the company believes increases the throughput and lowers Covid-19 testing costs, as well as the cost of other pathogen tests.

Roche has announced that its cobas SARS-CoV-2 Nucleic acid test was granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA). This is the first test Covid-19 RT-PCR test that can detect SARS-CoV-2 infection among symptomatic and asymptomatic individuals in just 20 minutes. It runs on the cobas Liat System, and will also be available in countries that accept the CE mark.

9:34 am

Coronavirus company news summary – University of Edinburgh scientists trial non-invasive Covid-19 saliva test – UK government passes new laws for private Covid-19 tests

Researchers from the University of Edinburgh have launched a Covid-19 test called the TestEd to detect the SARS-CoV-2 infection from a saliva sample deposited in a tube. The researchers have applied an innovative approach called hypercube sample pooling where a large number of samples can be processed at once. The Medical Research Council (MRC) recently awarded TestEd a $2.50m grant to scale up its testing of students and staff to reaffirm its efficacy.

According to new draft legislation from the UK government, all Covid-19 molecular and antigen tests available for purchase will have to be validated before being marketed in tthe country from 1 September 2021. The law is expected to bring all private Covid-19 tests in line with the standards of the NHS Test and Trace device. The government already ensures safety measures for all PCR and LFD tests provided through NHS Test and Trace and for all tests used for international travel.

Therma Bright has provided an update on the performance of its AcuVid Covid-19 rapid antigen saliva test in a Brazilian clinical study, which enrolled 63 subjects into a nasal swab RT-PCR test and a saliva-based AcuVid test. The test showed 100% specificity for the 28 RT-PCR negative samples and 100% sensitivity for the 28 positive RT-PCR results.

9:53 am

Coronavirus company news summary – University of Strathclyde unveils cost-effective, saliva-based Covid-19 test – University of Arkansas and NOWDiagnostics collaborate for Covid-19 antibody test

UK researchers from the University of Strathclyde are developing a rapid, low-cost saliva-based biosensor test for Covid-19 that can be mass-manufactured for as little as 20 pence per test. Inspired by glucose test strips used for monitoring blood sugar levels among diabetics, the test is designed for rapid in-field use to allow people in community settings to determine their Covid-19 status.

The North Carolina Department of Health and Human Services (NCDHHS) announced that the state is expanding the availability of at-home Covid-19 test collection for all eligible North Carolinians. Any resident can receive a Pixel by Labcorp Covid-19 PCR test home collection kit after placing an order online or through any partner organisations, which is shipped overnight free of cost. The tests can be used for individuals aged two years and older.

The University of Arkansas and NOWDiagnostics have announced an active partnership for a Covid-19 antibody test and prevalence study that would determine the occurrence of SARS-CoV-2 virus antibodies among its students, faculty, and staff. The ADEXUSDx Covid-19 test is a rapid serology, self-contained assay that assesses the presence of SARS-CoV-2 antibodies and delivers results in just 15 minutes. The study aims to test one enrolee three times over four months, the recruitment for which began in March 2021.

10:21 am

Coronavirus company news summary – Actim’s SARS-CoV-2 rapid test receives CE mark approval – ALBOT to develop and distribute CRISPR Covid-19 diagnostic kits in India

Biodesix, a diagnostic solutions company, has announced the commercial launch of a SARS CoV-2 neutralisation antibody test, the cPass neutralisation test kit. The test uses ELISA technology to detect circulating neutralising antibodies produced in response to a Covid-19 vaccine and infection. It is the first and only surrogate neutralising antibody test to have received Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA).

Actim, a Finnish-based diagnostics company, recently received a CE mark for its new easy-to-use rapid antigen test for detecting acute Covid-19 infection in minutes. Intended for healthcare professionals only, the test identifies the infection in nasopharyngeal swab samples without the need for laboratory equipment. It has proven high reliability in diagnosing different Covid-19 variants.

The 221b Foundation, a non-profit organisation established by biotechnology company Sherlock Biosciences, has granted a license to ALBOT USA and ALBOT Technologies Private Limited India to develop, manufacture and distribute Covid-19 diagnostic tests utilising Sherlock’s CRISPR technology. ALBOT can produce approximately 30,000 test kits per day, which will be distributed across government laboratories and facilities to meet the diagnostic testing needs of all regions.

10:01 am

Coronavirus company news summary – Aventus launches a Covid-19 variant test – Rhode Island announces Covid-19 test site consolidation plan

The US Food and Drug Administration (FDA) has reviewed a Pre_IND request from BioVaxys Technology for a type B review of its CoviDTH programme. The FDA has stated that a written response is sufficient to carry out a phase III study of BioVaxys’ T-cell immune response diagnostic for SARS-CoV-2. It has stated that the response for bioproduction and clinical development will be available by 23 July 2021.

Aventus Health has announced the launch of its Covid-19 variant test, developed to identify known SARS-CoV-2 virus variants and to discover novel ones. Aventus’ Covid-19 variant test was created through a next-generation sequencing technology and a laboratory-developed assay, which together break down the sequence of base pairs that comprise the genetic makeup of the various strains. The test could have a role to play in the tracking and understanding of emerging Covid-19 variants and their impact on public health.

Governor Dan McKee and the Rhode Island Department of Health have announced plans to consolidate state-run Covid-19 test sites. About a dozen or more of the high-volume Covid-19 testing sites in Rhode Island are expected to close by the end of the month, with state officials instead looking to focus on the most vulnerable populations. Mobile and pop-up testing sites are now being organised in areas that need it the most, such as low-vaccinated regions, travel destinations, schools and others which have experienced severe outbreaks.

9:44 am

Coronavirus company news summary – BD to provide Covid-19 screening for Olympic trials and other events – Quidel’s new Sofia Q rapid antigen test receives amended EUA

BD has entered into a partnership USA Swimming, the national governing body for swimming in the US, to conduct Covid-19 screening tests for US Olympic team trials and other USA Swimming events. Rapid antigen tests using the BD Veritor Plus System will be carried out as an additional safety measure beyond the PCR testing at all Olympic trials, as well as at all 2021-2022 USA Swimming events where testing is required.

Quidel Corporation has received an amended Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) to market its Sofia Q, the latest addition to the Sofia and Sofia 2 line of fluorescent immunoassay analysers. Sofia Q is a smaller test device using fluorescent technology to provide accurate and automated results in just 15 minutes. The sale of the device will initially be limited to use with the Sofia SARS Antigen FIA in the clinical laboratory improvement amendments (CLIA) and CLIA-waived professional setups.

Avacta Group, a biotechnology company developing diagnostics and cancer therapies, announced that the company’s AffiDX SARS-CoV-2 antigen lateral flow test has been registered in the EU. The notification of registration allows the company to market its products across all 27 EU member countries for professional use. Clinical data of Avacta’s lateral flow test showed 100% sensitivity in identifying individuals with viral loads measured by PCR of Ct less than 27.

9:35 am

Coronavirus company news summary – Trivitron unveils mobile laboratory for Covid-19 testing – Promega receives CE mark for Covid-19 antibody test

Trivitron Healthcare has announced the launch of a mobile laboratory to facilitate Covid-19 diagnosis in rural, urban and remote locations. The lab is expected to be deployed in rural and inaccessible areas of India and is capable of processing approximately 2,500 samples every day, including RT-PCR tests, rapid antigen tests, CLIA/Elisa antibodies tests IgG and IgM and CLIA/Elisa tests for inflammatory markers like D-Dimer, CRP and IL-6.

Promega has received a CE mark for its Covid-19 antibody test, the Lumit Dx SARS-CoV-2 Immunoassay, which will now be available in Europe. The new bioluminescent immunoassay is a qualitative in vitro diagnostic test, which detects antibodies against the SARS-CoV-2 virus in serum. It is being regarded as a simple, scalable, and reliable method for detection.

Safeguard DNA Diagnostics, a Philippines-based molecular microbiology diagnostic laboratory, has launched the Rhinostics dry nasal and nasopharyngeal collection swabs for Covid-19 testing. The swabs are being introduced at its facilities in Davao, Metro Manila and Negros Occidental. The company will also be the exclusive supplier of Rhinostics in the Philippines. The swabs have received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA), and allow for easy sample collection, dry shipment, as well as transport without viral transport media.

10:16 am

Coronavirus company news summary – Weavr Health files EUA request for Silk Covid-19 antibody test – Roche’s SARS-CoV-2 Antigen Self Test Nasal receives CE mark approval

Weavr Health has submitted an Emergency Use Authorization (EUA) request to the US Food and Drug Administration (FDA) for its Silk Covid-19 Rapid Antibody Test. When authorised, the company’s test could be the first Covid-19 antibody test delivering testing results for IgG and IgM antibodies within ten minutes. The Silk is a lateral flow test, which requires a fingerstick blood draw, offering easy administration for home use. The EUA request will allow the distribution and use of the test at non-healthcare and point of care settings for individuals 18 years and older.

Roche has received a CE mark for its SARS-CoV-2 Antigen Self Test Nasal. The test is expected to be available in packs of five at all pharmacies and other locations in countries accepting the CE mark. An earlier version of the test is already available for home tests in European countries since February 2021. The test is integrated with NAVIFY Pass, Roche’s digital solution that displays all information related to Covid-19 result and vaccine status through a unique QR code.

LivFul and Global Access Diagnostics (GAD) have entered into a new partnership to provide a number of Covid-19 test kits, starting with rapid antigen tests, to low and middle incomes countries. GAD’s Covid-19 rapid antigen tests have a reported sensitivity of 90.6% and a specificity of 100%. The WHO recommends a minimum of 80% sensitivity and >97% specificity to minimize false positives.

10:09 am

Coronavirus company news summary – Thermo Fisher launches assay for Covid-19 surveillance – FDA grants EUA to OraSure’s Covid-19 rapid antigen tests

Thermo Fisher Scientific has launched the Ion AmpliSeq SARS-CoV-2 Insight Research Assay. The assay is designed to help identify new and known Covid-19 variants from samples with lower viral loads. It sequences more than 99% of the SARS-CoV-2 genome, covering all potential serotypes. The assay enables workflow automation and reduces the turn-around time for insights and data.

Biotechnology company Avacta Group announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA), has registered its AffiDX SARS-CoV-2 antigen lateral flow test. Clinical data for the antigen lateral flow test showed 100% sensitivity in identifying infectious individuals with viral loads measured by PCR of Ct<27.

OraSure Technologies has announced that the US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the company’s Covid-19 rapid antigen tests, the InteliSwab. The InteliSwab Covid-19 Rapid Test is now available for over-the-counter (OTC) non-prescription use, the InteliSwab Covid-19 Rapid Test Pro is available for professional use and the InteliSwab Covid-19 Rapid Test Rx is available for home use.

10:25 am

Coronavirus company news summary – MyBio launches Covid-19 antigen self-test in Ireland – Reliance to launch new Covid-19 drug and RT-PCR test kits

MyBio, an Irish life sciences company, has launched a new Covid-19 antigen self-test in Ireland, which is available for purchase in Applegreen and Circle K stores across the country. The company has partnered with MP Biomedicals, a German company, to deliver an affordable and accurate product for testing. The developers say the test has undergone a rigorous validation process and demonstrates an accuracy of 97.83%.

Reliance Industries is working to combat ventilator shortages across India, using continuous positive airway pressure (CPAP) machines with a 3D-printed charlotte valve and special snorkelling mask. It has also sought regulatory permission to repurpose niclosamide, a generic drug used to treat tapeworm infestations, for potential covid-19 treatment.

9:11 am

Coronavirus company news summary – ICMR approves Abbott’s home-based rapid antigen test kit – iXensor launches a fully digitised PixoTest Covid-19 rapid test

The Indian Council of Medical Research (ICMR) has approved Abbott‘s PanBio Covid19 Antigen Test Device, the second Covid-19 test kit designed for home use to be approved by ICMR. The device received provisional approval till the 5 of July this year, after which the business will announce the price of the kit.

Eurofins Technologies has announced the unveiling of its GSD NovaType III SARS-CoV-2 RT-PCR test, which is designed for the rapid detection of Covid-19 variants of concern. The test identifies relevant mutations E484Q, E484K, and L452R in a combined reaction to the simultaneous discrimination of E484 variant of the S gene. These mutations have been found to reduce the efficacy of some vaccines and have reported increased transmissibility of the virus.

iXensor, a medical device company and a mobile health pioneer, has announced that its PixoTest POCT Covid-19 antigen test has received the European CE-IVD mark. The fully digitised screening solution can deliver results in just 15 minutes, and consists of a rapid antigen test, a website, and a digital health and admin app.

10:02 am

Coronavirus microblog – Mexico approves Sorrento’s COVI-STIX for emergency use – Eurobio Scientific commercialises its antigenic Covid-19 self-test

Biopharmaceutical company Sorrento Therapeutics has has its Covid-19 rapid antigen test COVI-STIX placed on the official list of point-of-care rapid antigen tests approved for emergency use in Mexico. According to InDRE, an independent government testing laboratory in Mexico, COVI-STIX outperformed among the tests for both sensitivity and specificity. Sorrento has begun all import and commercial roll-out activities and is expecting the test to be available for customers within weeks.

Applied DNA Clinical Labs has secured a safeCircle pooled Covid-19 surveillance testing contract with Camp Chateaugay, a summer camp programme for teenagers and kids in New York’s Adirondack Mountain region. The acquisition is indicative of the re-opening of places for opportunities in which Covid-19 pooled surveillance testing aims at lowering the risk of virus spread.

Eurobio Scientific, a French group specialising in in-vitro medical diagnostics, announced that the company will begin marketing its new proprietary test EBS 1005, a self-administered Covid-19 antigen test. The test has also received a waiver to be marketed until it receives a CE marking, and is expected to be sold in sets of five across pharmacies or under government contracts.

9:23 am

Coronavirus company news summary – Genetic Technologies and Infinity BiologiX partner for Covid-19 risk test – University of Bath develops world’s first handheld Covid-19 test device

Genetic Technologies has announced the launch of its Covid-19 Serious Disease Risk Test in the US through a collaboration with the biotechnology company Infinity BiologiX. As per the agreement, IBX will manufacture, sell, and distribute GENE’s test across its recognised network. The Covid-19 risk test is available to all individuals aged 18 years and older.

A Montana State University (MSU) team has illustrated how ancient strategies used by bacteria to battle viruses can be repurposed to fight Covid-19. Using CRISPR, a bacterial immune system technology, MSU researchers have developed a new diagnostic tool to accurately detect even small amounts of the SARS-CoV-2 virus in patient samples in under 30 minutes. Researchers claim that the test can also be used to identify other viruses such as Ebola and Zika.

The University of Bath has been working on a world-first handheld Covid-19 test device, which is expected to deliver accurate results in just 10 minutes. Developed by Bath’s Centre for Biosensors, Bioelectronics and Biodevices (C3Bio) members, the LoCKamp test conducts a genetic-based diagnosis, offering high accuracy levels in detecting the SARS-Cov-2 virus. It is about the size of a mobile phone and is able to take samples, identify DNA sequences and reveal results in within ten minutes.

10:16 am

Coronavirus company news summary – France to offer additional medical supplies to India – Montenegro and NATO collaborate on procuring medical equipment

France announced that it will be sending additional medical supplies to India, as the country fights its second wave of infections. The medical supplies will include 16 large oxygen generation plants, and is expected to be France’s largest solidarity operation carried out during the pandemic. A special cargo plane carrying ten oxygen generation plants is expected to arrive in India in mid-June, with a second expected to follow. Each of these high-capacity plants can produce 24,000 litres of oxygen per hour.

Montenegro and the North Atlantic Treaty Organisation (NATO) have entered into a procurement agreement for medical supplies. Montenegro will arrange for the purchase and delivery of the medical equipment, an MRI scanner and an x-ray machine, to beneficiaries in Montenegro’s health sector, while NATO will contribute €430,000 to the projects, as part of its Pandemic Response Trust Fund. The medical equipment will be used in a hospital in Berane, to reduce the pressure on the clinical centre in Podgorica, the only city using such equipment.

The Institute for Human Services, a Hawaiian agency focused on ending or preventing homelessness, is working to provide Covid-19 diagnostics for the homeless population in Hawaii. Capture Diagnostics and Visby Medical will be donating PCR testing devices to the facility. Visby’s Covid-19 diagnostic has helped Capture secure test results in just 30 minutes, thereby improving the speed of care extended towards the homeless population.

9:08 am

Coronavirus company news summary – Eurofins awarded agreement for Covid-19 testing expansion – TaqPath Covid-19 test kit available for incoming travellers in the UK

Clinical Enterprise has been awarded a US government agreement to expand the scope of Covid-19 testing nationally. The agreement with the US Department of Health and Human Services (HHS), along with the US Department of Defence (DOD), will see expanded testing across K-8 schools, underprivileged communities and homeless shelters. As per the agreement, Eurofins is expected to test approximately 24.6 million citizens in the Northeast and South regions.

Thermo Fisher announced that its TaqPath Covid-19 CE-IVD approved RT PCR kit has been authorised and meets the performance criteria for Covid-19 quarantine protocol testing for international travellers arriving in the UK on their second and eighth day. The UK has introduced quarantine rules for international travellers, under which a ten-day quarantine and PCR test is mandatory on arrival.

PerkinElmer announced that its contract to run the UK NHS Test and Trace Newport Lighthouse laboratory has been extended until March 2022. The collaboration plays a key role in the UK government’s efforts to fight the Covid-19 pandemic. The laboratory has been able to process more than two million samples since October 2020. The extension will see the facility scale its testing capacity to tens of thousands of tests daily.

9:58 am

Coronavirus company news summary – BioFlyte unveils airborne Covid-19 detection system – Macedonia receives PPE and diagnostic instruments from WHO

Applied DNA Sciences has competed technical validation of its seven research-use only mutation detection assays. Contained within its Linea Covid-19 Selective Genomic Surveillance (SGS) Mutation Panel across 125 Covid-19 variant clinical samples, the results found 100% concordance when compared to Whole Genome Sequencing (WGS) results of the same samples. The SGS Panel can run for hours and can use the same viral RNA used to obtain the original Covid-19 diagnosis. The company is planning on seeking emergency use authorisation for the panel once the validation is deemed successful.

Biodetection company BioFlyte announced that the company has introduced the Sentinel Airborne Covid-19 Detection System for real-world scrutiny and identification of airborne coronavirus, as well as other respiratory pathogens. Expected to be the first airborne detection solution of this nature, the Sentinel delivers results within an hour, thus preventing the spread of the infection in schools, factories, and other workplaces. The system is quick, cost-effective and helps prevent prolonged exposure to infected individuals.

The World Health Organisation has delivered personal protective equipment (PPE) and diagnostic tools to the North Macedonia Ministry of Health/Institute of Public Health to support the country’s fight against Covid-19. The supplies include face shields, biohazard bags, protective goggles, medical gowns and technologies for Covid-19 diagnosis. The support aims at safeguarding frontline workers, bolstering testing capacities and preventing further spread of the disease.

9:37 am

Coronavirus company news summary – PhysIQ and institutions collaborate to develop Covid-19 digital biomarker – Innova to produce millions of Covid-19 tests in the UK

PhysIQ, a digital health company, announced that Intermountain Healthcare Utah, Rush University Medical Centre, and The University of Texas Health Science Centre at Houston have joined its National Institutes of Health (NIH)-funded DeCODe study to develop an artificial intelligence (AI)-based Covid-19 digital biomarker. These institutions will recruit and act as key partners in the phase II validation study. The biomarker is expected to help scale the early detection of rapid clinical decompensation in high-risk Covid-19 patients.

Biotechnology company ProMIS Neurosciences has begun commercialising its Covid-19 serology assay and has appointed executive and entrepreneur Owen Dempsey to lead the commercialisation. The programme will target the need for a highly accurate test to identify, quantify and analyse antibodies against the SARS-CoV-2 virus, either due to contracting the infection or in response to vaccination. The new serology test will measure serum antibodies against Covid-19, and also its protective action against the infection.

Innova has reportedly made a large investment in the UK to start creating millions of Covid-19 tests every day at a Wales plant this summer. The Covid-19 tests are expected to be developed for domestic use and export. Owned by private-equity fund Pasaka Capital, Innova has provided the UK with over one billion tests developed as part of a more than $4.24bn contract in Fujian, China.

9:24 am

Coronavirus company news summary – India’s Mylab producing 100 million Covid-19 test kits per week – Megna requests EUA extension for its rapid Covid-19 antibody test

Mylab Discovery Solutions, a molecular biology company developing and commercialising human diagnostic tests, has announced that it can produce 100 million units of its at-home Covid-19 test kits every week over the next few months, depending on demand. While the use of at-home tests is not prevalent in India, the Mylab test kit is the first to have received such approval as the country struggles to battle the third wave of infections.

US-based rapid Covid-19 tests developer Megna Health announced that it has filed an application for the extension of its Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the prescription home use of its rapid Covid-19 IgG/IgM antibody test. The easy-to-use product can give a result within 15 minutes using a drop of fingerstick sample.

Quidel Corporation has announced that Health Canada has approved its Sofia SARS Antigen FIA test. It is the first rapid antigen test to receive authorisation in the country for serial testing that will help detect SARS-CoV-2 infection in both symptomatic and asymptomatic individuals.

9:14 am

Coronavirus company news summary – Therma and K-One MediTech partner for Covid-19 rapid antigen saliva test – First at-home test kit receives EUA for younger children

Therma Bright has secured a development and manufacturing deal with the medical device manufacturer K-One MediTech to market the Acuvid Covid-19 rapid antigen saliva test kit to the public. K-One will produce the test kits in Asia and the two-year agreement period will commence from the first batch of produced test kits for the commercial market.

Online at-home health testing provider empowerDX announced that its Covid-19 testing kit has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for children aged three years and older. It is the first test to receive such authorisation for at-home PCR nasal test for younger children. The company introduced its at-home Covid-19 test kit for consumers aged 18 years and older in the fall of 2020. The test kits are now available without a prescription on the company’s website, Amazon, via Uber’s on-demand deliver, and RiteAid.

Simon Fraser University researchers from Canada have approved a faster, and more cost-effective Covid-19 rapid test kit that is expected to scale the access and speed of rapid testing. The researchers have suggested that the test can be used in remote locations, airports, clinics, as it’s easy to administer and transport. The microchip test has the ability to provide accurate results within 30 minutes and requires ten times fewer reagents than in other approved RT-PCR tests.

9:10 am

Coronavirus company news summary – Cipla and Ubio Technologies launch the ViraGen test kit – Achiko transports first Covid-19 diagnostic test kits to Indonesia

Pharmaceutical company Cipla has collaborated with Ubio Technologies Biotechnology Systems, a diagnostics devices manufacturer, to launch a polymerase chain reaction (RT-PCR) Covid-19 test kit called the ViraGen in India. The test kit is expected to be commercially available to consumers on 15 May 2021. This is Cipla’s third Covid-19 testing kit, while the company has already struck deals for antibody detection kit and antigen test kits.

XPhyto Therapeutics has announced that its logistics, distribution, and storage partner, Max Pharma will make the company’s 25-minute rapid point-of-care Covid-19 RT-PCR test system (Covid-ID Lab) available for purchase in Germany on 25 May. The test is registered under the European Union (EU) as a commercial in vitro diagnostic (CE-IVD) test.

Achiko’s biotechnology division announced that it has completed the production of its first batch of 1,000 AptameX Covid-19 diagnostic test kits and has already begun shipping the kits to Indonesia. The company claims AptameX delivers a sensitivity of 77% at a high industry CT score of 28.3, is still highly sensitive at low viral loads. The company is moving to complete product registration in Indonesia and is focused at securing a CE Mark in Europe.

9:33 am

Coronavirus company news summary – DoorDash and Vault Health team up for Covid-19 test deliveries – FDA rules out antibody testing for testing immunity after vaccination

PathShodh Healthcare has developed a breakthrough semi-quantitative electrochemical ELISA test for Covid-19 IgM and IgG antibodies. The Indian Central Drugs Standard Control Organisation (CDSCO) has granted the start-up a licence to manufacture the test for commercial use, after validation at the Translational Health Science and Technology Institute (THSTI), and according to Indian Council of Medical Research (ICMR) requirements.

Online food ordering and delivery platform DoorDash has collaborated with Vault Health to deliver same-day Covid-19 tests in Cleveland. The at-home test kits have to be ordered before 1 p.m., while patients will receive an email to track the delivery. A Vault staff is also expected to remotely supervise the use of the test, confirm the identity of the individual, guide users in collecting the right amount of saliva, and to answer their queries. The test results can be expected within a day at the partner lab.

The US Food and Drug Administration (FDA) issued a safety statement warning the public not to rely on the results from SARS-CoV-2 antibody tests to determine their immunity or protection against Covid-19. The FDA will be continuously evaluating authorised SARS-CoV-2 antibody tests for other purposes.

9:56 am

Coronavirus company news summary – Seegene strikes $4.8m diagnostic kits deal with Kuwait – Health Canada authorises Ortho’s first high-volume Covid-19 test

South Korean molecular diagnostics firm Seegene subsidiary Seegene MIDDLE EAST has entered into an exclusive supply agreement with Kuwait’s Ministry of Health. As part of the agreement, Seegene will be providing Covid-19 diagnostic kits worth more than $4.8m to Kuwait. It is expected to be the largest volume of consignment to be procured by the country since a year. Seegene is looking to further expand its global footprint by securing procurement deals with countries such as Italy, Germany, the Middle East, and Scotland.

Ortho Clinical Diagnostics has announced that its VITROS SARS-CoV-2 Antigen Test, has been approved by Health Canada. The test can deliver results on the same day and can run up to 130 tests each hour. It is run on the company’s high-volume VITROS Systems, which are installed across more than 5,600 laboratories globally.

Health technology company binx health announced that it has submitted an Emergency Use Authorization (EUA) request to the US Food and Drug Administration (FDA) for the first Clinical Laboratory Improvement Amendments (CLIA)-waived CRISPR-based point-of-care Covid-19 test. Developed in collaboration with biotechnology company Sherlock Biosciences, the binx io platform is capable of detecting both bacterial and viral infections. If authorised, it is expected to increase access to rapid Covid-19 testing and treatment.

9:23 am

Coronavirus company news summary – Eurofins develops new tests to detect emerging Covid-19 variants of concern – MyHealthChecked and Boots sign Covid-19 test contract

Eurofins Technologies has launched two new tests: the GSD NovaPrime Plus SARS-CoV-2, a PCR test to detect key mutations of variants of concern in one reaction, and the GSD NovaType Select L452R SARS-CoV-2 (RUO), to detect critical variants such as the ones found in California, India and the US. Eurofins is expected to invest further in the development of reliable and high-quality Covid-19 and variant testing solutions.

ZEUS Scientific, a medical equipment manufacturer, announced that the US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to its in vitro ELISA diagnostic test to detect total (IgG/IgM/IgA) antibodies against the SARS-CoV-2 virus in human serum and plasma. This test is expected to be readily available to all clinical laboratories in the country.

MyHealthChecked announced that it has signed a second contract with UK pharmaceutical retailer Boots for its at-home Covid-19 nasal swab test kit. The agreement extends its offering to include tests for international arrivals to the UK, on the second and eighth day of their arrival. The test is expected to be available on the Boots website.

9:39 am

Coronavirus company news summary – QuickVue at-home Covid-19 Test now available to US consumers – Anderson Diagnostics and TataMD partner for Covid-19 test kit production

Quidel announced today that its QuickVue at-home over-the-counter Covid-19 test is now available to US consumers through Amazon. The test does not require a prior prescription from the doctor and delivers results in just 10 minutes from nasal swab samples.

Anderson Diagnostics has partnered with Tata MD to support the production of the TataMD Check, an India-manufactured Covid-19 test kit. The collaboration is expected to scale the production of test kits, thereby optimising testing in the country. Based on the Feluda CRISPR technology, the test kit has already been used to conduct more than 10,000 tests.

10:00 am

Coronavirus company news summary – Applied DNA’s LineaTM Covid-19 Assay Kit receives EUA – US FDA grants EUA to QIAGEN’s Covid-19 antibody test

Applied DNA Sciences has announced that its Linea Covid-19 Assay Kit has been re-issued Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) to include asymptomatic screening of individuals via serial testing. The expanded intended use allows for screening individuals with or without symptoms, reduces prescription time, and returns results directly to individuals. The test is now available for immediate purchase by Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories across the country.

Qiagen has been granted EUA by the US FDA for its digital QIAreach Anti-SARS-CoV-2 Total Test. The authorisation allows the company to provide its portable antibody testing device to all healthcare professionals in the US. One antibody test takes about 10 minutes to identify the presence of antibodies in individuals against the SARS-CoV-2 virus as a result of a prior infection. The test results are read on a digital eHub device capable of processing up to 32 tests every hour., an online platform that supports Covid-19 mitigation strategies, announced that it has collaborated with the Arizona State University (ASU) and Project N95 to enable organisations to remain open or resume operations, by facilitating the provision of Covid-19 diagnostic tests in small or large numbers from approved suppliers.

10:03 am

Coronavirus company news summary – Oxford Immunotec’s T-SPOT.COVID Test to be used in COV-AD clinical study – Rokline Health receives licence to manufacture Covid-19 diagnostic kits

Oxford Immunotec has announced that its T-SPOT.COVID test will be utilised for T cell testing in a clinical study called the Covid infection in patients with antibody deficiency (COV-AD), to assess the clinical course of the SARS-CoV-2 infection and the immunological response of patients to vaccines. The study is being carried out in collaboration with the University of Birmingham and aims to collect samples from 13 sites across the UK. The study will establish whether individuals with antibody deficiency mount durable immune responses, and if not, the impact it has on the virus.

221b Foundation, a non-profit organisation started by biotechnology company Sherlock Biosciences, has offered a licence to Rokline Health Concepts for developing and manufacturing Covid-19 diagnostic test kits using Sherlock’s CRISPR technology. The agreement aims to increase testing capacity across the US and offers a path for the development and delivery of high-throughput, accurate and automatable solutions like the SHERLOCK to directly benefit Covid-19 patients.

Applied DNA Clinical Labs, a subsidiary of biotechnology company Applied DNA Sciences, has received a Clinical Laboratory Improvement Amendments (CLIA) certification from the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) for high throughput diagnostic Covid-19 testing, using methods and devices authorised for emer use, including the company’s Linea Covid-19 Assay Kit.

9:57 am

Coronavirus company news summary – FDA approves QUANTA Flash SARS-CoV-2 IgG in the US – Hong Kong approves INDICAID Covid-19 rapid antigen test

Inova Diagnostics has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its QUANTA Flash SARS-CoV-2 IgG to be used on BIO-FLASH random access chemiluminescent analyser. The QUANTA Flash has demonstrated high accuracy in the detection of IgG antibodies to the nucleocapsid and spike proteins of the SARS-CoV-2 virus, with 100% specificity in patients with confounding conditions and 100% sensitivity in patients after 15 days from being tested positive.

Seegene‘s German subsidiary is participating in the government’s Back-to-School programme, the Lolli-Test, in an effort to return to normalcy. The company is expected to deliver Covid-19 diagnostic tests to laboratories in a weekly basis for nine weeks, starting in May until the beginning of the summer break, for about $23.4m. The diagnostic tests will then be delivered to about 400 laboratories in the North Rhine-Westphalia region to test more than 734,000 pupils at 3,764 special and elementary schools.

The Hong Kong government has approved the Covid-19 rapid antigen test INDICAID, developed by biotechnology company PHASE Scientific International, as one of the designated rapid tests after care homes resume visitation from 10 May 2021. The INDICAID Covid-19 rapid antigen test is a CE-marked lateral flow immunoassay that helps detect SARS-CoV-2 antigens in direct nasal swab samples, delivering results in just 20 minutes.

9:35 am

Coronavirus company news summary – Nicoya develops saliva-based rapid Covid-19 test – XPhyto begins pilot project to optimise rapid Covid-19 PCR test in Germany

Nicoya Lifesciences is expected to complete the prototype of an affordable, single-use, self-administered Covid-19 test named Atlas, to detect active infection, mutant strains, and other viruses. The Atlas test uses a simple saliva collection kit and provides result in 20 minutes. Funded by the National Research Council of Canada (NRC), the company is developing the test together with the Public Health Agency of Canada (PHAC) as part of a joint challenge issued through the government’s Innovative Solutions Canada (ISC) programme.

XPhyto Therapeutics has initiated a pilot project with its rapid 25-minute Covid-19 PCR test, Covid-ID Lab, in a point-of-care setting in Germany. The pilot project includes mobile collection and PCR processing of the patient’s samples as well as testing of workflow logistics for further optimisation. The project is being undertaken in collaboration with Spitzweg Apotheke, a well-known German pharmacy.

At-home Covid-19 test kits have been made available over the counter in the St. Louis area. The different testing options include the Abbott BinaxNOW test, which is now available in CVS, Walgreens, and Walmart pharmacies, and Quidel QuickVue and Ellume, which will hit the stores in the coming weeks.

10:03 am

Coronavirus company news summary – Therma Bright to distribute new rapid Covid-19 antibody test – PerkinElmer to donate one million rapid Covid-19 antigen tests to India

Therma Bright has agreed to distribute its new AcuVid™ Covid-19 rapid antibody test to detect antibodies against the SARS-CoV-2 virus. The 15 minute rapid antibody test uses blood samples to detect antibodies with 96.6% sensitivity in individuals currently infected or previously infected but undiagnosed Covid-19 patients or vaccinated individuals.

Season Biomaterials, has launched its 4S molecular diagnostic system at the Seoul National University (SNU) campus in South Korea as the first on-site rapid Covid-19 diagnostic centre. The 4S features negative pressure rooms and molecular diagnostics equipment for sample collection and molecular examination of infectious diseases such as Covid-19.

PerkinElmer will donate one million of its PerkinElmer® Covid-19 antigen tests to India to increase the pace of testing across the country amid the surging Covid caseloads. The test kits will be distributed to government hospitals and testing centres across ten states of the country, with the assistance of the US-India Strategic Partnership Forum (USISPF). The test is a lateral flow immunoassay capable of delivering results in 15 minutes and is suitable for point-of-care and non-clinical settings.

9:46 am

Coronavirus company news summary – Ortho Clinical Diagnostics’ Covid-19 antibody test receives CE Mark – Department of Homeland Security contracts MRIGlobal for Covid-19 testing solutions

Ortho Clinical Diagnostics’ VITROS® Anti-SARS-CoV-2 IgG quantitative antibody test has received the European CE Mark for the evaluation of immune response after infection or vaccination. The test allows physicians to determine the level of immune response of an individual to SARS-CoV-2 after infection or vaccination. This could help track virus transmission, as well as an individual’s antibody levels.

The US Department of Homeland Security (DHS) has awarded four contracts to MRIGlobal. The contract research organisation, has a base period of one year and four one-year option periods to provide Covid-19 testing solutions to ensure workplace safety and reduce exposure risk to the virus. The contracts will include the provision of managed testing services and the molecular diagnostic test kits and testing services and have a shared ceiling value of up to $2bn.

AXIM Biotechnologies’ manufacturing partner Empowered Diagnostics has applied for the emergency approval of ImmunoPass™, a semi-quantitative rapid Covid-19 test, at point-of-care settings across Canada and the European Union (EU). The test enables the detection of Covid-19 neutralising antibodies in whole blood and is also being reviewed by Health Canada for use in the country.

9:59 am

Coronavirus company news summary – Sentinel Diagnostics introduces two new Covid-19 serological tests – RxBIO distributes Covid-19 saliva collection kit in Canada

Sentinel Diagnostics has launched two new serological tests, COVID-19 Anti-S1 Total Ab and COVID-19 Anti-NC Total Ab. The tests are able to detect antibodies (IgA, IgG and IgM) developed following a Covid-19 infection. The in vitro diagnostic assays can provide initial results in about ten minutes and assist in distinguishing vaccinated people from those infected naturally.

RxBIO is distributing Spectrum Solutions‘ SDNA saliva collection kit for Covid-19 for the first time in Canada. The collection kit is a saliva-based test system that offers a comfortable alternative to the painful nasal swab method. The three-component kit is the first saliva-based system to be approved by the US Food and Drug Administration (FDA) under Emergency Use Authorization (EUA) and has also been approved by Health Canada.

The Hamilton County Health Department is offering free, rapid Covid-19 test kits to households within Chattanooga and Hamilton County under the Say Yes! COVID Test At-Home Testing Challenge. The programme will encourage the residents to administer the test thrice a week, irrespective of the symptoms.

10:13 am

Coronavirus company news summary – 221b Foundation and LogicInk to develop non-invasive Covid-19 diagnostic – AXIM Biotechnologies develops new ELISA test for emerging Covid-19 variants

221b Foundation and LogicInk have partnered to develop an instrument-free, non-invasive, saliva-based Covid-19 diagnostic biosensor. The diagnostic device will integrate Sherlock Biosciences’ CRISPR diagnostic technology with LogicInk’s DNA nanotechnology proprietary platform. It is expected to enable people to self-administer and detect the presence of SARS-CoV-2 RNA.

FluroTest Diagnostics Systems has collaborated with Total Testing Solutions to launch a first-of-its-kind pilot programme to introduce a high-volume Covid-19 testing system in California. The companies intend to move the test from the LA-based screening facilities, which are utilising it for research only purposes to commercial scale use, subject to receiving approval from the US Food and Drug Administration (FDA).

AXIM Biotechnologies has introduced a new ELISA test that measures levels of immune protection against six common variants of the SARS-CoV-2 virus in less than two hours. The test may also provide insights about the efficiency of vaccines against SARS-CoV-2 variants to vaccine developers.

10:18 am

Coronavirus company news summary: LUCIRA™ CHECK IT Covid-19 home test receives FDA authorisation for over-the-counter sale – Oxford Immunotec’s T-SPOT Discovery SARS-CoV-2 test to be used in DIRECT study

Converge Technology Solutions and Lucira Health have received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the over-the-counter sale of the LUCIRA™ CHECK IT test kit for Covid-19. The test can be self-administered by an individual at home and get results in 30 minutes. The developers claim the test has PCR-level molecular accuracy.

The University of Utah, ARUP Laboratories and Techcyte have partnered to develop NanoSpot.AI, a rapid Covid-19 antibody test. The test is performed on a blood sample obtained through a finger prick and can provide results in less than five minutes. Currently under clinical studies for validation, the test could be utilised to determine the priority for vaccination or quick testing for travel and immigration purposes.

Oxford Immunotec will utilise its T-SPOT® Discovery SARS-CoV-2 kit for T-cell testing in the DIRECT clinical study, which is being conducted to determine the immune response of ethnic minority healthcare workers to Covid-19 infection or vaccination. The company is conducting the study in collaboration with researchers at the University of Leicester and is funded through the National Core Studies group.

9:52 am

Coronavirus company news summary: Alercell to begin distribution of Clip Covid Rapid Antigen Test in the US – Therma Bright collaborates with Afero to develop smart AcuVid™ Covid-19 rapid test

Alercell, a US-based biotechnology company, will begin to distribute the Luminostics’ Clip Covid Rapid Antigen Test together with its antigen Covid-19 test collection kits across the US. It can rapidly test the presence of infection in the patient by looking for the antigens in the sample taken from nose or throat. The test has already received emergency use authorisation from the US Food and Drug Administration (FDA) for point-of-care use in CLIA laboratories.

Therma Bright has collaborated with Afero, an IoT platform, under a memorandum of understanding (MOU) to integrate the latter’s security and tracking technology into the 15 minute AcuVid™ Covid-19 test. The Afero-powered AcuVid™ Covid-19 test can be tracked and reported for quality assurance, shipping, logistics, and point-of-care test results and may further be approved for at-home testing. The technology developed by Afero will allow millions of test results to be shared with government bodies, workplaces, places of recreation and more.

Xtrava Health has received a $6.2m contract from the US National Institutes of Health (NIH) under the Rapid Acceleration of Diagnostics (RADxSM) initiative to accelerate the launch of its SPERA™ Covid-19 antigen test. The analytical and clinical trials expenses as well as programme management and marketing plans for the test are being supported by the RADx initiative. The Covid-19 test has been validated by Emory University, which also evaluated its clinical performance.

9:51 am

Coronavirus company news summary: Oxford Immunotec Covid-19 test used in UK Com-COV Clinical Trial – Beroni Group’s SARS-CoV-2 antigen test kit secures export authorisation

Oxford Immunotec has announced that its T-SPOT® Discovery SARS-CoV-2 kit will be utilised in the UK Com-COV clinical trial to evaluate T-cell immune response in people administered with two different approved Covid-19 vaccines as the first and second doses during vaccination. The clinical trial is being conducted in collaboration with the Oxford Vaccine Group and funded by the UK Vaccine Task Force and the National Institute for Health Research (NIHR).

Mobilus Health, a US-based mobile rapid molecular testing solutions provider, has developed the Mobilus DX Laboratory, a turnkey mobile testing solution, to support rapid Covid-19 molecular testing in medically underserved communities, schools, municipalities, and private companies. The first Mobilus DX Laboratory was procured by a CLIA lab based in Georgia. The laboratory utilises patented real-time multiplex technology to reduce the turnaround time for testing as it runs an RNA extraction free testing platform.

Beroni Group, an Australia-based diversified biopharmaceutical enterprise, has received export authorisation for its SARS-CoV-2 Antigen Test Kit (Colloidal Gold Method). The test kit provides Covid-19 test results within ten minutes. The test kit has previously secured the CE mark for distribution in the European Union markets.

9:54 am

Coronavirus company news summary: SpeeDx gets CE-IVD mark for two gene test – Health Canada approves first home-based self-test for Covid-19

Australia-based molecular diagnostic solutions company SpeeDx received CE-IVD mark for its PlexPCR SARS-CoV-2 assay, a two-gene test performed to detect Covid-19 infection. The test is compatible with 96 or 384-well qPCR systems and liquid handling robotics to enable efficient laboratory workflow.

Canadian health regulator Health Canada authorised the use of Lucira Health’s CHECK IT Covid-19 test kit for self-testing at home for both symptomatic and asymptomatic patients. The company claims that the test gives PCR quality molecular accuracy within 30 minutes or less. It will available across Canada by June.

PathogenDx has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its DetectX-Rv diagnostic assay. DetectX-Rv uses reverse transcription polymerase chain reaction and DNA microarray hybridisation to detect SARS-CoV-2 gene in nasal swabs and bronchoalveolar lavage specimens.

9:28 am

Coronavirus company news summary: US dispatches Covid-19 test kits and therapeutics to India – NIH awards $21m to Minute Molecular Diagnostics for Covid-19 testing kit

The Biden administration is set to dispatch therapeutics, rapid diagnostic test kits, protective gear and ventilators to India following the recent surge in Covid-19 infections. White House sources further revealed that the country will be pursuing ways to provide oxygen generation as well as related supplies immediately. According to Anthony Stephen Fauci, the director of the US National Institute of Allergy and Infectious Diseases, the government will also be considering sending AstraZeneca vaccine doses.

The US National Institutes of Health (NIH) has awarded Minute Molecular Diagnostics’ Covid-19 testing kit $21.3m million to fast-track the development and manufacturing of its cartridges and readers. The test can deliver results for two different nasal swab samples in 15 minutes. The funding from the NIH’s Rapid Acceleration of Diagnostics (RADx) competition.

eMed has announced that its at-home Covid-19 rapid testing platform is now available in Spanish to certified guides who direct users virtually on how to use the BinaxNOW rapid antigen test.

9:47 am

Coronavirus company news summary – XPhyto signs agreement with German company for Covid-19 PCR test – FDA authorises Enzo’s AMPICOLLECT sample collection kit in the US

XPhyto Therapeutics has signed a distribution, storage and logistics agreement with a German pharmaceutical wholesaler and service provider for the distribution of its diagnostic products. The agreement seals a full-service deal with the company to distribute its 25-minute Covid-19 RT-PCR test called the Covid-ID Lab. The test is registered within the EU as a commercial in vitro diagnostic CE-IVD test.

Enzo Biochem has announced that the US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to its AMPICOLLECT sample collection kit. The test can be used with Enzo’s proprietary GENFLEX molecular diagnostic platform, along with other PCR-based molecular diagnostic platforms or antigen-based testing platforms.

Ceres Nanosciences has been awarded a contract of $8.2m by the US National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Initiative to support the development and execution of wastewater-based surveillance systems for the detection of the SArs-CoV-2 virus. The systems will be powered by the Nanotrap particle technology in various sites with a focus on vulnerable populations.