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

9:50 am

Coronavirus company news summary – AnteoTech gets CE Mark for Covid-19 test – FidaLab and Ginkgo Bioworks partner for pooled testing in US schools

AnteoTech has received CE Mark registration for its EuGeni Resear rapid test platform and Covid-19 test, Covid-19 ART. The EuGeni Covid-19 antigen rapid test uses nasopharyngeal specimens to detect the disease. It has an overall sensitivity of 97.3% and specificity of 99.6%.

FidaLab has announced a partnership with Concentric by Ginkgo Bioworks, a biotech company, to provide pooled testing services to K-12 schools in the US. More than 800 schools across the US have signed up to pooled classroom testing with Concentric.

Allabout Innovations, an incubator in India’s Kerala Startup Mission, has developed an electronic device to contain the spread of the SARS-CoV-2 virus through air. The Wolf Airmask performs real-time air sterilisation, rupturing the SARS-CoV-2 virus. A first-of-its-kind in the country, the device can reportedly reduce 99% of the virus in the air within 15 minutes.

9:57 am

Coronavirus company news summary – Collection Sites makes Covid-19 at-home testing available across US – Helix and Ginkgo Bioworks partner to support back to school Covid-19 testing in US

Collection Sites, a wholly owned subsidiary of Medivolve, has expanded its Covid-19 testing services by launching a US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) approved at-home PCR Covid-19 testing kit across the US. The at-home test kits are available without prescription by individuals through retail partners as well as through the Collection Sites website.

Helix, a population genomics company, has announced a partnership with Ginkgo Bioworks to provide simple, easy, scalable, affordable, and pooled Covid-19 testing services to K-12 schools across the western US. The partnership will enable schools to reopen, a critical part of the Biden-Harris administration’s national strategy.

Researchers from the Vellore Institute of Technology (VIT), India, are developing an aptamer-based point-of-care (POC) diagnostic kit to detect Covid-19, reports BioSpectrum India. The project is being funded by the Indian Science and Engineering Research Board (SERB) of the Department of Science and Technology (DST).

9:45 am

Coronavirus company news summary – Applied DNA and Northwell Health develop SARS-CoV-2 mutation and variant tracking programme – BreathTech and Cleveland Clinic collaborate for breath analysis study

Applied DNA and Northwell Health, New York State’s largest healthcare provider, have entered into a pro bono material transfer agreement to establish a real-time surveillance programme to track and identify SARS-CoV-2 mutations and variants of concern (VoCs). The programme currently has over 2,000 samples underway, with early results from about 360 showing 80% of the specimens containing one or more mutations.

Premier Medical Corporation is planning to apply for Emergency Use Authorization (EUA) with US Food and Drug Administration (FDA) for its Covid-19 rapid antigen test. The company is submitting the Sure Status Covid-19 Antigen Card Test for distribution and use of the test in the US. This comes after the test was included by the World Health Organization (WHO) in its emergency use list.

Astrotech subsidiary BreathTech Corporation has signed an investigator-initiated study agreement with the Cleveland Clinic Foundation, a non-profit academic medical centre. As per the terms of the agreement, BreathTest-1000 will be used to compare breaths of infected people against those tested negative. The test is expected to analyse different volatile organic compounds (VOCs) from breaths to determine the correlation with different disease states.

9:40 am

Coronavirus company news summary – FDA authorises Symbiotica Covid-19 self-collected antibody test system – MicroGenDX announces SARS-CoV-2 whole genome variant identification

The US Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the Symbiotica Covid-19 self-collected antibody test system, the first approved antibody test with home collected dried blood spot samples. Samples collected at home are then sent to Symbiotica, an artistic research laboratory for review. It is a prescription use test, which is authorised for self-collection for individuals aged 18 years and older, can be collected by adults for children aged five years and older.

MicroGenDX has announced the launch of Covid-19 Variant ID, a whole genome sequencing service to detect known variants of the SARS-CoV-2 virus described as epidemiologically significant by the US Centres for Disease Control and Prevention (CDC). It is expected that whole genome testing and research of SARS-CoV-2 will help discover new approaches to tackle the emerging variants. Researchers have already revealed that variants carrying the E484K mutation may escape immune response in some vaccinated individuals.

QIAGEN has announced the addition of QIAseq DIRECT SARS-CoV-2 Kit to its Covid-19 portfolio. The viral genome enrichment and library preparation solution reduces library turnaround times and plastics use. The kit analyses over 6,000 samples simultaneously on highest-throughput sequencers, and integrates with QIAGEN’s cloud solutions for variant detection and reporting.

9:45 am

Coronavirus company news summary – BrainChip and Biotome enter into a research collaboration for SARS-CoV-2 antibody detection – Phillippines procures 500,000 antigen kits

Eurofins Viracor has announced the launch of the cPass Coronavirus SARS-CoV-2 neutralising antibody test, which is designed to detect a recent or prior infection to the virus. The ELISA-based method detects neutralising antibodies to the receptor binding domain of the viral spike protein. The test has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for use by laboratories certified under clinical laboratory improvement amendments (CLIA) to perform highly complex tests.

BrainChip Holdings has announced that the Brainchip Research Institute in Perth and Biotome have entered into a research collaboration to develop highly accurate antibody tests for detecting infections. BrainChip’s Akida neuromorphic processor chip will be used to interpret sensor responses and to assess which responses are most representative for protective antibodies.

The Philippines Office of the Civil Defence (OCD) has been authorised to procure an initial 500,000 rapid antigen kits under its Inter-Agency Task Force for the Management of Emerging Infectious Diseases (IATF-EID) Resolution No. 108. As per the resolution, the OCD can use quick response funds to buy rapid antigen kits to ensure quick detection and tracing of infected individuals. The kits are approved by the FDA.

10:35 am

Coronavirus company news summary – Oxford BioDynamics and Agilent sign agreement and launch EpiSwitch Explorer Array Kit – Abbott receives FDA approval for rapid antigen self-test

Oxford BioDynamics and Agilent Technologies have signed a supply and resale agreement to manufacture and sell the new EpiSwitch Explorer Array Kit. The kit is available for high-resolution 3D genome profiling and biomarker discovery. The EpiSwitch platform has already been used to develop the recently launched Covid-19 Severity Test, EpiSwitch CST.

Abbott has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the over-the-counter, non-prescription, asymptomatic use of its BinaxNOW COVID-19 Ag Self-Test. The test will be available to individuals with or without symptoms and without a prescription. Abbott is expected to start shipping to major food and drug retailers in the coming weeks.

BioVaxys Technology has applied for pre-IND (Investigational New Drug) meeting request and submitted a briefing package with the FDA for Covid-T, its T-cell immune response diagnostic for SARS-CoV-2. BioVaxys expects a written response to its pre-IND briefing package later this month. Covid-T uses delayed-type hypersensitivity (DTH), a measure of T-cell immunity used for other infectious diseases such as fungal diseases, tuberculosis, and mumps.

2:51 pm

Coronavirus company news summary – OraSure seeks FDA approval for Covid-19 rapid antigen test – BD gets FDA approval for combination Covid-19, flu rapid antigen test

OraSure Technologies has submitted an application to the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its Covid-19 rapid antigen test. The EUA would allow for the test to be used as an at-home prescription test, as well as for professional use in point-of-care (POC) settings. OraSure has started manufacturing the assay test alongside the EUA submission.

BD has received EUA from the FDA for its new, rapid antigen test that can detect SARS-CoV-2, influenza A and B in one sample. The BD Veritor System delivers results within 15 minutes and is expected to launch the test in the summer of 2021-2022.

Olive Labs and Concentric by Ginkgo are working together to provide a simple and accessible testing modality for Covid-19-pooled testing, targeting US schools operating hybrid or in-person learning. Concentric runs testing across 15 states, with more than 800 schools signed up for its affordable testing programme.

9:18 am

Coronavirus company news summary – QIAGEN gets US FDA authorisation for NeuMoDx™ Vantage Assay test – UK BioBank COVID-19 Antibody Study to use AbC-19™ Rapid Test

QIAGEN has received US Food and Drug Administration (FDA) authorisation for the NeuMoDx™ Flu A-B/RSV/SARS-CoV-2 Vantage Assay. The test will help to identify suspected individuals for respiratory viral infection consistent with Covid-19. The test is one more addition to the company’s PCR testing solutions portfolio.

The UK Rapid Test Consortium (UK-RTC) is using the AbC-19™ rapid neutralising antibody test for phase two of the UK Biobank Coronavirus self-test antibody study. The finger-prick home-testing kit gives results in 20 minutes and can detect neutralising IgG antibodies to the full trimeric spike protein of the Covid-19 virus.

Escher Biomedical Diagnostics, a joint venture of Biotrack and Echo Testing Group, has developed a test kit to detect Covid-19 virus in saliva samples. The test is called BT-MED® COV19 Test and used in CLIA-high-complexity laboratories. The testing device includes a fluorescent molecular probe, which is used along with automated intelligent digital image processing to evaluate the presence or absence of the virus.

Ryvex, a clinical diagnostics company, and SD Biosensor, a bio-diagnostic company, have donated over 20,000 rapid antigen test kits to the Organization of Eastern Caribbean States (OECS) countries and to Barbados. The donated kits have been approved by the World Health Organization (WHO) and are expected to be delivered this week.

9:51 am

Coronavirus company news summary – US FDA approves Amazon’s at-home Covid-19 test – UK to offer free rapid Covid-19 testing to businesses under workplace testing programme

The US Food and Drug Administration (FDA) has approved Amazon’s Covid-19 test kit, developed through its subsidiary STS Lab Holdco. The test kit will be used by Amazon to test its workforce under the Covid-19 preparedness and response programme, according to an FDA filing. The nasal-type test can also be used as an at-home test.

Researchers in Brazil have developed a new diagnostic tool for Covid-19 patients that uses artificial intelligence (AI) to detect Covid-19 in the via chest X-rays with a reported 95.6% to 98.5% accuracy. The diagnostic tool is planned to be tested with larger datasets, with the aim of developing an online platform for medical image classification. They published their results in IEEE/CAA Journal of Automatica Sinica, a joint publication of the Institute of Electrical and Electronics Engineers and the Chinese Association of Automation.

The UK government has made rapid Covid-19 testing available for all businesses with over ten employees in case they cannot afford on-site testing, as part of its workplace testing programme. More than 60,000 businesses have enrolled for at-home testing of workers under the programme, which employs lateral flow tests to diagnose the a case of Covid-19 within 30 minutes.

9:59 am

Coronavirus company news summary – Therma Bright moves to Health Canada approval for Covid-19 antigen kit – Thermo Fisher completes FDA listing and launches the qPCR platform for Covid-19 testing

Therma Bright has submitted an application to Health Canada seeking approval to conduct a clinical study for its AcuVid Covid-19 Rapid Antigen Saliva Test. The company already received institutional review board (IRB) approval from the US Food and Drug Administration (FDA).

1health, a testing as a service (TaaS) company, and The Vitamin Shoppe have announced that they have collaborated to make available a simple, self-administered test for US consumers nationwide. Under the agreement, the tests will now commercially available for sale on The Vitamin Shoppe’s site.

Thermo Fisher Scientific has completed FDA listing for the Applied Biosystems QuantStudio 5 Dx Real-Time PCR system. The system allows clinical laboratories and assay developer to meet testing demands more efficiently and enhance their molecular diagnostics workflows. The system’s simplified, efficient workflow minimizes steps to deliver quality results in as little as 30 minutes. The system has high sensitivity and specificity and offers up to six channels for multiplexing.

9:34 am

Coronavirus company news summary – US FDA authorises LetsGetChecked’s home collection Covid-19 test – Xlear submits Covid-19 pre-emergency use authorisation to FDA for nasal spray

LetsGetChecked has announced that the US Food and Drug Administration (FDA) has authorised the use of its home collection Covid-19 test, which is now available without a prescription. The test will be available for those who do not suffer Covid-19 symptoms or suspected exposure to the virus.

Aurora Biomed has announced that the company will start distributing the FaStep Covid-19 antigen rapid test device in the Canada this week. The 15-minute test is based on a lateral-flow immunochromatographic assay, and detects antigens specific to SARS-CoV-2 in nasopharyngeal samples of infected or exposed individuals.

Xlear, a xylitol-based products manufacturer, has filed for a pre-emergency use authorisation (Pre-EUA) approval with the US FDA for the use of its nasal spray in preventing SARS-CoV-2 transmission and infection. Earlier, the company had sought approval for nasal spray as a medical device to fight Covid-19. However, the FDA determined that it worked against the virus, and should therefore be considered as a drug or combination product EUA.

9:36 am

Coronavirus company news summary – Thermo Fisher and Artificial collaborate on Covid-19 diagnostic testing solution – FDA authorises Beckman Coulter’s SARS-CoV-2 IgG II antibody test

Thermo Fisher and Artificial, a developer of automation software, have entered into a strategic technology agreement to develop a software automation platform for Thermo Fisher’s standardised Covid-19 testing platform. The agreement is expected to scale Covid-19 testing volumes with improved software and robotics platforms. Artificial will allow its aLab Suite software to integrate with Thermo Scientific Momentum Workflow software and robotics hardware, while Thermo will utilise its experience to provide feedback to aLab Suite functionalities and capabilities.

Oxford BioDynamics has announced the launch of its EpiSwitch Covid-19 Severity Test (CST) in the US. The test is regarded as highly accurate in predicting severe illness caused by the SARS-CoV-2 virus. It requires a routine blood sample to identify high-risk individuals who may require hospitalisation and intensive care unit support. The test also enables care for individuals who cannot be vaccinated because they may be immunocompromised or due to other medical conditions.

The first antibody assay from Beckman Coulter, the Access SARS-CoV-2 IgG II, has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). The semi-quantitative assay measures the level of antibodies present in response to a previous SARS-CoV-2 infection. It also provides a qualitative and quantitative result of the antibodies in arbitrary units.

9:45 am

Coronavirus company news summary – DoorDash, Vault Health and Everlywell collaborate for on-demand delivery of Covid-19 PCR test collection kits – TataMD and Anderson Diagnostic Labs partner to detect Covid-19 variants

DoorDash has collaborated with Vault Health and Everlywell to deliver same-day Covid-19 PCR test collection kits to consumers across the US. The collaboration facilitates consumers’ access to two FDA- approved Covid-19 home collection kits through on-demand delivery from DoorDash’s DashMart locations.

Tata Medical and Diagnostics (TataMD) and Anderson Diagnostic Labs have partnered to detect Covid-19 variants from the UK, Brazil, and South Africa with the TataMD CHECK diagnostic kit. The test kit has been approved by the Indian Council of Medical Research (ICMR), and has already conducted more than 10,000 tests. It is being looked at an alternative to RT-PCR tests.

Monoclonal antibodies have been making headlines since Eli Lilly‘s Bamlanivimab and Regeneron‘s Casirivimab/Imdevimab received EUA to treat mild-moderate COVID-19 in November 2020. The DripAssist Supplemental Infusion Rate Monitor, a test developed by Hometa, provides a middle ground between the simplicity of gravity infusion, and the certainty of a pump to deliver these treatments. The device secures to the drip chamber of an IV set and counts drops with 99% accuracy using an infrared sensor. It operates continuously for 270 hours on a single AA battery, viable for emergency use such as a power outage or pump shortage, and in austere/pop-up medical clinics.

8:42 am

Coronavirus company news summary – FDA authorises first ML-based Covid-19 non-diagnostic screening device – UK to develop fast test for Covid-19 variants

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to the first machine learning-based Covid-19 non-diagnostic screening device. The Tiger Tech COVID Plus Monitor is an armband with embedded light sensors and a small computer processor which identifies biomarkers that are typical to conditions like hypercoagulation or blood clotting. It will be used by trained personnel to prevent exposure and spread of the virus. The device identifies the SARS-CoV-2 virus, along with other conditions and allergies in asymptomatic individuals over the age of 5.

Stimdia Medical, a company that specialises in the development of lung pacing devices, has received FDA’s approval for its pdSTIM system. The Breakthrough Device designation allows the device to be used to treat difficult conditions and gain regular access and priority to the FDA. The system can be used in treat high risk Covid patient, to recondition the diaphragm and strengthen the primary muscle used in respiration. The device is expected to reduce weaning time for patients on mechanical ventilation.

The UK government is currently developing a test genotype assay test, which will be able to detect Covid-19 variants of concerns from coronavirus test samples. According to the UK government’s health ministry, the test is expected to halve the time required to detect Covid-19 variants and will be used alongside standard testing to identify cases more rapidly, thereby curbing the virus spread and easing restrictions.

9:49 am

Coronavirus company news summary – Macrogen’s gets CE-IVD certification for Covid-19 antibody fast-test kit – XPhyto announces European approval for Covid-19 PCR test

Macrogen has received a European community in-vitro diagnostic device (CE-IVD) certification for its fast-test kit for Covid-19, the Axen™ COVID-19 IgM/IgG RAPID. The kit can detect the presence of antibodies within 15 minutes using a small blood sample. It demonstrated 97% accuracy in the Seoul National University Hospital clinical trial. Macrogen secured the overseas business rights for the ImmuneMed kit in February and will export the kits as its own brand.

Aptamer Group, a biotechnology company, has entered into a partnership with Mologic, a lateral flow and rapid diagnostic tests developer, to work towards acquiring the CE mark for Aptamer’s AptaDx SARS-CoV-2 lateral flow rapid antigen test for professional use. The test detects the viral spike protein antigen in anterior nasal swabs. Initial test results have shown high sensitivity to detect the virus and other dominant emerging variants.

Pharmaceutical company XPhyto, and its exclusive Germany diagnostics development partner 3a-diagnostics, have received European approval for its point-of-care Covid-19 RT-PCR test systems called the Covid-ID Lab. The test has demonstrated high sensitivity, specificity, and robustness and can deliver results in 25 minutes. The Covid-ID Lab is now registered within European Union (EU) as a commercial in vitro diagnostic (CE-IVD) test and is expected to be launched for sale by April 2021.

9:33 am

Coronavirus company news summary – BioAcumen Global to make freeze-dried Covid-19 PCR test – Uganda unveils home-made coronavirus testing kits

BioAcumen Global has developed a freeze-dried Covid-19 PCR test kits technique called lyophilisation, which eliminates the current need to refrigerate the test kits. With the help of lyophilisation, the kits can be stored and transported with ease, and can be preserved at room temperature without any degradation. BioAcumen has now opened a new lyophilisation facility, with a capacity to freeze-dry 2,400 PCR tests in a single day.

Uganda has locally developed rapid test kits for Covid-19 screening. Lead developer Dr Misaki Wayengera, alongside staff and students at the Makerere University, will be the first to receive the rapid antibody test kits. Dr. Wayengera, who also developed the Ebola testing kits, stated that the new Covd-19 testing kits are approved by the National Drug Authority. The testing kit is expected to cost approximately $1 per kit and delivers results in just five minutes.

Teräcero Pharma, along with its German partner nal von Minden, has announced that Health Canada has issued an authorisation for the import and commercialisation of Minden’s NADAL Rapid Test. Teräcero has the exclusive rights to distribute the test in Canada. The test has a sensitivity of 95% after 15 days of symptom appearance, which increases to 98% after 21 days and to 99.5% at 25 days or more.

9:14 am

Coronavirus company news summary – Breathonix develops one-minute Covid-19 breath test – Roche launches SARS-CoV-2 variant test

Breathonix, a spin-off company from the National University of Singapore (NUS), has developed a rapid breath test that can detect the SARS-CoV-2 virus within a minute. A joint trial between Mohammed Bin Rashid University of Medicine and Health Sciences (MBRU), Dubai Health Authority (DHA), and Breathonix, is taking place in Dubai. The company’s initial pilot study in 180 patients achieved a sensitivity of 93% and specificity of 95% with the machine learning algorithm.

University of Rhode researchers have developed a new Covid-19 saliva test that will be used across its campuses for screening and surveillance of the SARS-CoV-2 virus. The test is less invasive than other nasal swab tests, is both specific and sensitive, and can deliver results at lower costs.

Roche has announced the launch of the cobas SARS-CoV-2 Variant Set 1 test which detects and differentiates mutations that were found in Covid variants across the UK, Brazil, and South Africa. The research use laboratory test is expected to help scientists in tracking mutations and analysing the impact on vaccines, diagnostics, and therapeutics.

10:07 am

Coronavirus company news summary – BCMA to supply 10 million Covid-19 RTK Antigen kits to Thailand – Fujifilm receives CE certificate for Covid-19 antigen kit

BCM Alliance Bhd (BCMA), a Malaysia-based company, has received a supply order of RM320 million ($77.8m) for Covid-19 test kits via its wholly owned subsidiary BC Medical Sdn Bhd (BMSB). BMSB has entered an agreement with MTPS Innotech (MTPS) to supply 10 million Covid-19 RTK Antigen kits to Thailand. The kits are expected to be shipped in batches over the course of a year.

Fujifilm has acquired the CE certificate and can thereby apply for the CE mark to launch its SARS-CoV-2antigen test kit. The test uses Fujifilm’s silver amplification immunochromatography method, which is based on silver amplification technology used to develop photographs, and can deliver results in 10-13 minutes.

Pelican Diagnostics has received a CE mark for its 25-second digital Covid-19 saliva test, which delivers real time results with 98% sensitivity and 100% specificity. The Pelican COVID-19 Ultra-Rapid Mobile Test is now available for sale and distribution in the EU. The US Food and Drug Administration (FDA) is currently reviewing the test for over-the-counter (OTC), self-test, and non-prescription use.

9:52 am

Coronavirus company news summary – Altimmune expands AdCOVID manufacturing collaboration with Lonza – Pathologists urge caution on at-home Covid test kits

RESPILON, a nanotechnology company, has launched the RespiPro VK Mask, an eco-friendly mask capable of blocking 99.9% of the bacteria, viruses, and other dangerous particles in the air, offering 30 hours of protection. It is able to physically block these particles because it is made of 0.01 micrometre-wide filter pores and copper oxide technology. The nano-fibre two-way filter masks are reusable and are certified respirators.

Altimmune, a clinical-stage biopharmaceutical company, has expanded its partnership with Lonza, a chemicals and biotechnology company, for the manufacture of AdCOVID, the former’s single-dose Covid-19 intranasal vaccine candidate. Under the expanded agreement, Lonza will provide a dedicated manufacturing suite for clinical and commercial production of AdCOVID at its facility near Houston, Texas.

Experts from the College of American Pathologists have warned about the downside of using at-home Covid-19 test kits that can produce inaccurate results due to mishandling of kits and tests producing adequate sample material. It is also being speculated whether some at-home test kits can detect viral antigens at all, and that a real-time PCR test is most accurate and sensitive for detecting Covid-19.

9:47 am

Coronavirus company news summary – FDA clears Zymo’s Covid-19 collection and transport device – Covid Apollo invests in Rhinostics to accelerate Covid-19 test volumes

Zymo Research been granted 501(k) clearance by the US Food and Drug Administration (FDA) for DNA/RNA Shield Collection Tube as a Class II medical device. The 510(k) clearance allows the product to be used as an in-vitro diagnostic (IVD) device for detecting the SARS-CoV-2 virus.

Covid Apollo, a project bringing together capital and expertise to scale potential Covid-19 diagnostic capabilities, has announced a Series A investment in Rhinostics. The Harvard University spinout has developed a novel nasal collection swab that can increase sample throughput more than 10-fold while removing labour and errors from the laboratory workflow. The swab is integrated onto a cap that can be automated for removal from the tube while 96 samples are simultaneously accessioned through scanning a 2D barcode on the bottom of the tubes.

Applied DNA Sciences has received a purchase order for its Linea Covid-19 Assay Kit and consumables to carry out 10,000 tests under a Master Services Agreement with an existing customer. The company expects to deliver most of these Assay Kits by the end of 31 March 2021, with the remaining kits to be delivered in the following quarter. This is the company’s third such blanket purchase order from the customer to be used for pooled Covid-19 surveillance testing.

9:50 am

Coronavirus company news summary – LivePerson and Innova Medical Group collaborate on AI-powered, at-home Covid-19 rapid testing – GetMyDNA’s Covid-19 test home collection kit gets emergency use authorisation

LivePerson, a global technology company that develops conversational commerce and artificial intelligence (AI) software, has collaborated with Innova Medical Group to launch BELLA Health, a first-of-its-kind Covid-19 rapid testing solution with AI-enabled instructions to ensure accuracy. The new test is currently being tested in the first, large-scale at-home rapid testing study in the US.

The US Food and Drug Administration (FDA) issued Emergency Use Authorization (EUA) to GetMyDNA’s Covid-19 Test Home Collection Kit DTC, which is directly available to consumers for both symptomatic and asymptomatic cases without a doctor’s prescription. While negative results of the test will be sent directly to the individual via email, positive results will be delivered through a healthcare provider.

Relay Medical and Fio Corporation, together with its joint venture company Fionet Rapid Response Group, announced that they have executed an agreement to oversee the deployment of the Fionet Pandemic Management Platform for on-site Covid-19 rapid testing at the Toronto Pearson International Airport. The Canadian government has funded this multi-million-dollar programme, restores flights departing from Toronto Pearson by testing staff and passengers.

9:43 am

Coronavirus company news summary – Empatica receives CE mark for early detection of Covid-19 using wearables – BD and ImageMover announce collaboration for rapid antigen test reporting

Empatica has received a CE certification for its wearable artificial intelligence (AI) enabled Aura system for the early detection of respiratory infections, including Covid-19, before the visible appearance of symptoms. Empatica received the CE mark for a class lla medical device, which means that Aura has met the safety and performance standards for marketability and distribution in Europe, making it the first product to receive the certification for detecting respiratory infections with intelligent wearable technology.

BD has collaborated with ImageMover, a software platform, to offer a companion mobile app that will streamline reporting of SARS-CoV-2 antigen testing based on the BD Veritor Plus System. This will be conducted across testing locations such as schools and businesses. The ImageMover app is currently available for BD Veritor Plus System customers.

Applied DNA Sciences has launched its Linea Covid-19 Selective Genomic Surveillance (SGS) Mutation Panel (the SGS Panel) to better track SARS-CoV-2 Variants of Concern. The newly developed SGS Panel detects specific mutations to focus limited next generation sequencing (NGS) capacity on the most impactful Covid-19 variants.

9:52 am

Coronavirus company news summary – Ortho’s new Covid-19 total and IgG antibody tests receive CE mark – Avacta’s rapid antigen test to detect SARS-CoV-2 new variants

Ortho Clinical Diagnostics has announced that its new VITROS Anti-SARS-CoV-2 Total 2 antibody assay and VITROS Anti-SARS-CoV-2 IgG 2 antibody assay have received the CE Mark for qualitative and semi-quantitative detection of Covid-19 antibodies. The antibodies can be acquired manually or through vaccination.

Talis Biomedical Corporation has withdrawn its current application for emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Talis One Covid-19 test in a clinical laboratory improvement amendments (CLIA) moderate setting. The company looks to focus on its planned EUA application in the CLIA waived setting.

Avacta Group, a developer of cancer therapies and diagnostics, has announced that its AffiDX SARS-CoV-2 rapid antigen lateral flow test is capable of detecting the dominant new Covid-19 variants, also known as the B117, or Kent variant, and the D614G variant, along with the original strain. The D614G variant, which appeared earlier on during the pandemic became a dominant strain globally.

9:51 am

Coronavirus company news summary – Abbott receives FDA EUA for laboratory PCR assay – Purdue Research Foundation and IdentifySensors partner on Covid-19 technology

Oxford Immunotec has released the T-SPOT.COVID test, a CE marked ELISPOT based test to detect a cell mediated (T cell) immune response to the SARS-CoV-2 virus in human whole blood. The company has also submitted an Emergency Use Authorization (EUA) request to the US Food and Drug Administration (FDA) for the test. The test can also be used alongside serology tests to support clinical assessment of individuals who present with suspected Covid-19 but may be PCR negative.

Abbott has announced that its Alinity m Resp-4-Plex molecular assay has been authorised by the FDA for EUA. The test is designed to detect the SARS-CoV-2 virus, influenza A, influenza B and respiratory syncytial virus (RSV) all at once. These viruses have similar symptoms but require different treatments. The test has received the CE mark and is approved in countries outside the US.

IdentifySensors Biologics, a Purdue University-affiliated technology company,  has entered into a new collaboration with the Purdue Research Foundation (PRF). IdentifySensors is currently developing a diagnostic platform for the detection of the SARS-CoV-2 virus. The company is expected to open an office in Purdue’s Discovery Park District, with the foundation expected to invest $50,000 in IdentifySensors. The company had approached Purdue earlier to help in the development of a nanosensor to detect spoilage and specific pathogens in the food supply chain.

9:42 am

Coronavirus company news summary – Seegene’s latest Covid-19 test can target four SARS-CoV-2 genes and multiple virus variants – Eazy Testing becomes AditxtScore channel partner for Covid-19 immunity status monitoring

Seegene announced that it has developed the world’s first variant diagnostic test, which that can simultaneously detect Covid-19 and screen for multiple virus variants. The Allplex SARS-CoV-2 Master Assay can detect ten different targets via primary real-time PCR testing in approximately two hours. The company will also be researching additional versions of variant diagnostic tests.

Aditx Therapeutics has announced that Eazy Testing, a Covid-19 testing and wellness centre, will be offering its AditxtScore for Covid-19 across locations in California. Eazy Testing currently offers Covid-19 testing services including rapid tests across nine locations across the state. It also provides at-location services for pre-tests passengers, individuals, and groups.

Genetic Technologies has announced a co-exclusive production and distribution rights and license agreement with US-based Infinity BiologiX, a next-generation central laboratory. The two companies will produce, distribute and sell the Genetic’s Covid-19 serious disease risk (SDR) test in the US. The test uses a combination of genetic and clinical information to predict the risk of an individual developing a serious disease should they contract the COVID-19 virus.

10:07 am

Coronavirus company news summary – BARDA and LightDeck partner to develop rapid SARS-CoV-2 antigen test – FDA approves UI’s coronavirus test

The Biomedical Advanced Research and Development Authority (BARDA) and LightDeck Diagnostics have partnered to create a six-minute SARS-CoV-2 antigen test, which can be used without a diagnostic laboratory. The point-of-care test can be used for on-site screening of Covid-19 at non-clinical settings, nursing homes, community testing sites, and essential workplaces.

University of Illinois researchers have obtained Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a saliva-based Covid-19 test.  The 99% accurate saliva-based test is expanded to all nine other public university campuses and to 48 community colleges. Approximately $20m in federal funds is expected to enable one million Covid-19 tests for Illinois colleges.

9:44 am

Coronavirus company news summary – Aegea and Biocept announce supply agreement for new Covid-19 test – Co-Diagnostics to develop new Covid-19 diagnostic testing platform

Aegea Biotechnologies, a life science company, and Biocept, a molecular diagnostic assays provider, have announced a supply agreement for a new PCR-based Covid-19 assay test kit co-developed by the companies. Aegea will supply the COVID-19 assay kit to Biocept for validation in its CLIA-certified, CAP-accredited high-complexity molecular lab and subsequent commercialization of a laboratory developed test (LDT).

Enzo Biochem has announced that its proprietary GENFLEX molecular diagnostic platform successfully detects the presence of Covid-19 variants. While its PCR testing does not differentiate between different variants, positive samples can be analysed further for variants. Current rapid antigen tests in the marketplace do not have this ability.

Co-Diagnostics is developing a new point-of-care, at-home PCR diagnostic testing, screening, and surveillance platform, capable of detecting Covid-19 and other diseases using its CoPrimer technology. The test can be performed at businesses, homes, schools, hotels, airports, airplanes, cruise ships, and in other locations.

9:47 am

Coronavirus company news summary – Eurofins announced launch of at-home PCR test kit for Covid-19 – FDA grants emergency use authorisation for home collection kit

Eurofins Clinical Enterprise has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for an updated version of its direct-to-consumer (DTC) empowerDX home Covid-19 collection kit. Eurofins’ Covid-19 home nasal PCR kit is directly available to US customers, without prescription, both online and at drug stores in the US.

Fluidigm Corporation has been granted EUA by the FDA for the AZOVA Covid-19 test collection kit, for use with the Fluidigm Advanta Dx SARS-CoV-2 RT-PCR assay on the company’s Biomark HD platform. The kit is authorised for at-home self-collection through prescription only, for individuals suspected to be suffering with Covid-19 symptoms.

Mobidiag has been granted CE-IVD marking for its Amplidiag RESP-4 molecular diagnostic test for the rapid and combined detection of prevalent respiratory viruses such as SARS-CoV-2 virus, Influenza A, Influenza B and respiratory syncytial virus (RSV).

9:49 am

Coronavirus company news summary – MatMaCorp’s Covid-19 2SF RNA test effective in detecting variants – Therma Bright signs agreement for Covid-19 saliva-based antigen test

MatMaCorp has announced efficacy data of its Covid-19 2SF RNA test when detecting SARS-CoV-2 variants. Preliminary evaluation of the data indicates that the test is capable of detecting more than 99.5% of the 3,801 coronavirus variants reported across the world till date.

Roche has been granted special approval by the German Federal Institute for Drugs and Medical Devices (BfArM) for its SARS-CoV-2 rapid antigen test. The test is expected to be widely available in Germany and enables at-home self-testing by patients with the help of a simple nasal swab.

Therma Bright has entered into an agreement with a Covid-19 testing site in the Greater Toronto Area to conduct a clinical trial of its AcuVid rapid antigen test, a saliva-based Covid-19 test. The testing site is expected to have one of the highest positivity rates in Ontario.

9:44 am

Coronavirus company news summary – Co-Diagnostics to offer at-home saliva collection kits for Covid-19 PCR test – NIH awards UC San Diego $33m for five Covid-19 diagnostic projects

Co-Diagnostics has announced that its laboratory partner Clinical Reference Laboratory’s (CRL) FDA-authorised saliva-based Covid-19 PCR test, which uses the company’s CoPrimer technology, is now available through Walgreens Find Care. The test gives consumers access to a convenient and non-invasive option for PCR-based Covid-19 testing from their homes.

The University of California San Diego has been awarded $33m by the National Institutes of Health (NIH) for five rapid acceleration of diagnostics (RADx) projects. The purpose of the RADx effort is to accelerate innovation in the development, implementation, and commercialisation of the technologies needed for Covid-19 testing.

The ongoing International Defence Exhibition (Idex) in Abu Dhabi has displayed the world’s first artificial intelligence (AI)-driven rapid Covid-19 antigen test system that delivers real-time coronavirus test results in just five minutes. The LooK SPOT AI Covid-19 antigen rapid test has been developed by Laipac Technology, alongside YAS Pharmaceuticals and Pure Health.

CityHealth has announced the launch of a new in-home Covid-19 test kit that allows infected patients to conduct medically supervised Covid-19 tests on their own in their homes. The test kit costs $39 for US residents, one of the most affordable remote testing kit available in the market.

10:35 am

Coronavirus company news summary – Quest Diagnostics introduces new Covid-19 semi-quantitative serology test service – BioIQ and Assurance Scientific Laboratories collaborate on new Covid-19 OTC at-home test kits

Quest Diagnostics has introduced a new Covid-19 testing service that will provide insights into an individual’s immune response due to a recent or prior infection or vaccination. The US Food and Drug Administration (FDA) maintains that serology tests help in identifying antibodies that can prevent infection as well as identify those still at risk.

BioIQ has partnered with Assurance Scientific Laboratories to bring over-the-counter (OTC), gold standard RT-PCR Covid-19 testing to market. The direct-to-consumer format approved by the US Food and Drug Administration (FDA) under Emergency Use Authorization (EUA), gives asymptomatic individuals access to Covid-19 testing solutions without a prescription.

XPhyto Therapeutics has placed the first order for its rapid point-of-care SARS-CoV-2 RT-PCR test system from 3a-diagnostics, its exclusive diagnostic development partner. The first order is for 9,600 individual tests which are packaged in 200 kits including 48 tests each. The delivery of the first order is expected in mid-March 2021.

MJ Biotech has announced that its sterile, FDA-approved nasal specimen collection swabs for the RT-PCR Covid test have been Covid-19 product offerings. This Covid-19 test is in addition to the Covid-19 IgG/IgM antibody rapid test kits already being offered by MJ Biotech.

10:09 am

Coronavirus company news summary – Cue Covid-19 test receives CE mark – QMC HealthID and Tried & Tested partner to support Covid-19 diagnostic testing in the UK

Adaptive Biotechnologies has launched the T-Detect COVID, the first clinical T-cell based test that can confirm either a recent or prior Covid-19 infection. In real-world studies, the first-in-class test outperformed other leading antibody tests. T-Detect is currently being reviewed by the US Food and Drug Administration (FDA) for emergency use authorisation (EUA).

Cue Health has announced that its molecular point-of-care Covid-19 test has received the CE mark, thereby allowing the company to sell and distribute the test across the EU. The Cue Covid-19 test is an extremely sensitive and specific nucleic acid amplification test (NAAT), which runs on the Cue Health monitoring system, delivering results in about 20 minutes via the Cue Health app.

QMC HealthID has announced a collaboration with Tried & Tested Covid-19 testing services to add new capabilities for coronavirus diagnostic testing in the UK. The QMC HealthID will allow individuals and companies to see and choose a particular Covid-19 test kit and record the test results.

9:43 am

Coronavirus company news summary – BD announces collaboration for Covid-19 home tCOPAN ships millions of Covid-19 test kits with Apple’s fund

BD and Scanwell Health, a smartphone-enabled at-home medical tests developer, have announced a partnership to develop an at-home rapid test for detecting the SARS-CoV-2 virus. The rapid test will utilise BD’s lateral flow antigen test and pair it with Scanwell’s mobile app to collect and transfer nasal swab samples and analyse the results.

COPAN Diagnostics has shipped more than 15 million Covid-19 sample collection kits across the US, after receiving $10m from Apple’s Advanced Manufacturing Fund. Apple, COPAN, and other US companies have collaborated to create and develop new machinery for COPAN’s Southern California facilities, which will have ultimately led to an increase in test-kit production by around 4,000% since April.

BioReference Laboratories is participating in the NY Forward Rapid Testing Programme by opening eight locations for Covid-19 rapid testing in New York. The programme is designed to offer New Yorkers, and those visiting, inexpensive rapid Covid-19 testing.

LightDeck Diagnostics has been awarded a $5.65m contract from the US Biomedical Advanced Research and Development Authority (BARDA) to develop a portable, rapid antigen test that can detect the SARS-CoV-2 virus. The funds will help LightDeck to developing a point-of-care antigen test that can deliver results in less than six minutes.

10:07 am

Coronavirus company news summary – LooK SPOT Covid-19 antigen rapid test receives CE IVD clearance for Europe – Virginia launches app-less technology to notify exposure to Covid-19

Laipac, an internet of medical things (IoMT) developer, has has received CE IVD clearance for its LooK SPOT Covid-19 antigen rapid test. The test, which delivers real time results in five to eight minutes, is a smartphone-based diagnostic device with a lateral flow immunoassay. It detects the nucleocapsid protein from SARS-CoV-2 in nasal swabs from suspected Covid-19 patients in the first eight days of the symptom onset.

The Virginia Department of Health has extended its existing COVIDWISE technology by announcing the launch of COVIDWISE Express, an app-less technology that notifies users if they may have been exposed to the SARS-CoV-2 virus. COVIDWISE Express was launched last week and is similar to the COVIDWISE app launched in August, but does not require downloading. It is only available to iPhone users.

Eone Diagnomics Genome Center, a bio-healthcare company, announced that it has received official approval from the Ministry of Food and Drug Safety to export its Covid-19 rapid test kit. The EDGC COVID-19 Ag test detects proteins that contain viruses from nasal and phlegm swabs.

10:58 am

Coronavirus company news summary – IISc and Oslo University’s AnamNet to assess severe lung infections in Covid-19 patients – New AI-enabled Quanto identifies most promising drugs for Covid-19

Researchers at the Indian Institute of Science have collaborated with colleauges at Oslo University Hospital and the University of Agder to develop a new software tool called the AnamNet, which detects the severity of lung infections in Covid-19 patients. The tool analyses chest CT scans to identify abnormalities in the lungs using deep learning techniques.

WorldQuant Predictive, an artificial intelligence (AI) company, and CAS, a division of the American Chemical Society, have entered into a partnership to develop an AI-powered virtual screening tool that will help researchers to quickly prioritise the most promising drugs for treating Covid-19 and other critical illnesses. The project aims to cut critical time to find cures of diseases to one week rather than the typical six to eight weeks.

Universal PropTech has completed an investment in data analytics company ISBRG for a minority interest and secured defined agency rights to the company’s SpotLight-19 technology. SpotLight-19 is designed to detect SARS-CoV-2 infection in less than 60 seconds using a non-invasive scan of a person’s finger with a harmless beam of light. As per the agreement, PropTech will have the exclusive rights to sell the technology and other future platform offerings to education and government sectors in Canada.

Sense Biodetection, a molecular diagnostics company, has announced the appointment of senior executives to lead the commercialisation of its products to provide patient-focused decentralised healthcare. The company has established a new distribution centre in Boston, Massachusetts as it prepares to launch its Veros Covid-19 test in the US and globally.

9:55 am

Coronavirus company news summary – Health Canada approves Roche’s SARS-CoV-2 rapid antigen test – Labcorp adds high sensitivity antigen test to screen active Covid-19 infection

A SARS-CoV-2 rapid antigen test developed by Roche has been approved under an interim order by Health Canada. The test enables quicker decision making and rapid isolation by healthcare professionals, thereby reducing further spread of the virus and delivering results within just 15 minutes.

Labcorp has launched a new laboratory-based antigen test that will help doctors identify only active Covid-19 infections. The test is developed by DiaSorin, an Italian biotechnology company, and is available to patients via doctors’ order. Traditional PCR tests can sometimes signal positive in the weeks following Covid-19 infection when they detect inactive viral remnants in a person’s swab, meaning they could end up isolating unnecessarily. Labcorp’s test is designed to help determine whether individuals are actively infectious, to give a better idea of whether it is safe or not for them to resume work-life activities.

Everlywell, a digital health company, has announced that its COVID-19 Test Home Collection Kit DTC is now authorised by the US Food and Drug Administration (FDA) for emergency use and without a prescription. The test kit is available for asymptomatic individuals and those with no suspected exposure to the virus, both online and on the shelves of retailers, pharmacies, and organisations.

Molecular Designs has developed a new PCR test that it says can differentiate the Covid-19 UK variant without the need for viral genome sequencing. Assurance Scientific Laboratories is now validating the test for clinical use in the US with results expected to be available by the end of the month.

10:06 am

Coronavirus company news summary – Kroger Health and Gauss partner for smartphone-enabled Covid-19 rapid antigen home tests – XPhyto completes European CE-IVD application for Covid-19 RT-PCR test

Kroger Health has announced a collaboration with Gauss, to offer the latter’s smartphone-enabled Covid-19 at-home rapid antigen test kit to patients across the US. The move expands the company’s existing portfolio of employer-focused and in-clinic Covid-19 testing solutions.

XPhyto Therapeutics, a bioscience accelerator, and its exclusive German diagnostics development partner, 3a-diagnostics, have completed all the procedures required for a European regulatory application for the Covid-ID Lab test system. 3a expects to receive device manufacturing and CE-IVD approvals by late February and early March, respectively.

Avricore Health has signed a Letter of Intent with Avrok Laboratories, a CLIA certified laboratory in California, to offer real-time Covid-19 screening to travellers in Canada, USA, Mexico, and the Caribbean. The move was initiated by significant interest expressed by consumers, airlines, and the government alike, who felt the need for a reliable programme to test travellers and resume international travel. LifeLabs and 

LifeLabs and Multiplex Genomics have announced a strategic partnership to expand testing capacity and Covid-19 variants in Canada. The companies are estimating that together they will be able to evaluate 20,000 Covid-19 samples every day, with plans to achieve testing 50,000 samples per day by mid-2021. In addition, every positive sample is expected to be sequenced and characterised to assign it to a variant.

9:52 am

Coronavirus company news summary – Bolsonaro seeks Israeli anti-Covid nasal spray for Brazil – Neogen launches wastewater detection screening for Covid-19

AptarGroup, a drug delivery, consumer product dispensing and active packaging solutions company, announced that its Activ-Film™ technology has been selected to protect against a new SARS rapid antigen test for Covid-19 diagnosis. The test  was recently granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA).

Brazilian President Jair Bolsonaro has announced that the country will be seeking emergency use authorisation for an Israeli-developed nasal spray to fight Covid-19. Israel describes the EXO-CD24, developed by the Ichilov Medical Centre in Israel, as a miracle treatment.

NEOGEN Corporation, an international food safety company, has announced the launch of Early Warning Covid-19 testing for wastewater. The solution is a piloted, accurate, and consistent test that monitors the presence of the SARS-CoV-2 virus in sludge from wastewater facilities. NEOGEN’s test aims to deliver precise results that quickly detect new disease outbreaks and provide early signs of infections and spread within facilities.

9:59 am

Coronavirus company news summary – FDA authorises Becton Dickinson’s Covid-19 combination test – GenScript receives FDA EUA to use cPass test in convalescent plasma screening

Becton Dickinson has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for a molecular test that can identify Covid-19 and influenza. The BD SARS-CoV-2/Flu test can deliver results within two to three hours and can detect both the UK and South Africa variants.

GenScript has been granted EUA for its cPass SARS-CoV-2 neutralisation antibody detection kit in convalescent plasma screening. The cPass test kit is the first FDA authorised test that detects Covid-19 neutralising antibodies without using the live virus.

Indonesia is now using rapid antigen tests as an first step when screening for Covid-19, to try and accelerate the rate of detection and reduce disease transmission. The Indonesian government is now distributing two million rapid antigen tests throughout the country. While PCR testing has better sensitivity and specificity, Indonesia’s laboratories are few in number and located primarily in big cities, meaning rural regions have been facing waiting times on PCR test of more than a week.

9:55 am

Coronavirus company news summary – ProterixBio announces commercial availability of quantitative Covid-19 serology test – Cue Health’s connected point-of-care Covid-19 test demonstrates 97.8% concordance

Eurofins has launched a new CE marked serological assay, the GSD NovaLisa SARS-CoV-2 (Covid-19) quantitative IgG, for identifying and measuring the level of antibodies to the SARS-CoV-2 virus. This ELISA kit detects antibodies raised by an infection or vaccination. The launch is expected to support vaccination campaigns by confirming the immune response to the virus and vaccines over time.

Proterixbio has sought commercial availability of a quantitative Covid-19 serology assay validated for dried blood spots (DBS) from a finger stick. An update from the SARS-CoV-2 (RBD) IgG antibody test, the assay is a testing service being offered through the company’s high-complexity Clinical Laboratory Improvement Amendments of 1988 (CLIA) testing laboratory.

Cue Health, a medical diagnostic products manufacturer, announced results from a Mayo Clinic Laboratories’ clinical validation study, which evaluated the accuracy of Cue’s Covid-19 test in point-of-care settings against the centralised lab PCR testing model. The study included 292 patient samples at a Mayo Clinic collection site. The study found that the overall agreement between the Cue point-of-care test and the reference laboratory tests was 97.8%.

BioIQ, a healthcare engagement and quality care gap closure company, and Biomeme, a real-time PCR testing solutions provider, have collaborated to bring Biomeme’s mobile RT-PCR Covid-19 test to BioIQ’s Covid testing platform and on-site testing events. The move aims to eliminate latency associated with sending samples away and false negatives/false positives associated with less sensitive, lower accuracy molecular and antigen tests.

9:45 am

Coronavirus company news summary – Visby Medical’s Covid-19 PCR point-of-care test authorised for use – Alveo announces CE mark for its be.well Covid-19 Flex Test

Visby Medical has announced that the US Food and Drug Administration (FDA) has authorised its rapid PCR Covid-19 test for use at CLIA waived point-of-care settings. Based on an earlier FDA approved Emergency Use Authorization (EUA), the company’s rapid PCR Covid-19 test can now be used by any organisation with a CLIA certification.

Kantaro Biosciences, a joint venture between the Mount Sinai Health System and RenalytixAI, and manufacturing partner Bio-Techne Corporation, announced that the FDA has added Covid-SeroKlir test to its revised EUA for convalescent plasma for treating hospitalised Covid-19 patients. The test can detect the presence and level of SARS-CoV-2 IgG antibodies with 98.8% sensitivity and 99.6% specificity.

Alevo Technologies, a pre-clinical stage medical diagnostics company, has received a CE mark for its be.well Covid-19 Flex Test that will help accelerate testing, treatment and surveillance of the disease. This is the company’s first regulatory approval, while it looks to submit an EUA to the FDA for the same test.

9:44 am

Coronavirus company news summary – Grapheal raises $2.30m to advance embedded biosensing technology for Covid-19 testing – ProPhase begins advanced, saliva-based viral PCR multiplex-testing for Covid-19 and other viruses

Grapheal, a developer of graphene-based embedded biosensors, announced that it has raised a total of $2.30m in equity and non-dilutive sources. The funds will be utilised to advance the development of Grapheal’s flexible graphene-based biosensor technology. The sensing technology will serve as a new generation digital Covid-19 test, TestNPass, for rapid screening at airports, as well as a wound care digital assistant, WoundLAB, will improve the monitoring of hard-to-heal wounds.

ProPhase Labs, a medical science and technology company, has started a new saliva-based, viral RT-PCR multiplex-testing as a laboratory developed test (LDT) classification. The company has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for its two new testing solutions. The company has integrated Spectrum Solutions SDNA-1000 Saliva Collection Systems along with an advanced multiplex qPCR platform for the simultaneous detection of the SARS-CoV-2 virus, influenza A & B, and other viral mutations.

Nanomix, a point-of-care diagnostics developer, announced that the company has submitted an EUA to the FDA for the eLab Covid-19 rapid antigen test. The assay runs on the mobile Nanomix eLab analyser, which delivers results within 15 minutes and can be used across hospitals, assisted living facilities, nursing homes, urgent care centres, and emergency medical care.

9:47 am

Coronavirus company news summary – Roche files FDA EUA for SARS-CoV-2 rapid antigen test – Avacta and Mologic sign a deal to accelerate its Covid-19 antigen test

Roche has submitted an Emergency Use Authorization (EUA) application to the US Food and Drug Administration (FDA) for its SARS-CoV-2 rapid antigen test. The test allows healthcare professionals to take informed decisions based on quick, reliable results within 15 minutes at point-of-care settings among patients experiencing Covid-19 symptoms.

Avacta has entered into a commercial partnership with Mologic, a rapid diagnostics company, to accelerate its lateral flow Covid-19 antigen test to market. Avacta is one of the first companies to be working on lateral flow tests for Covid-19 using its Affirmer reagents. The antigen tests deliver results within minutes without any laboratory intervention.

Kantaro Biosciences, a joint venture between the Mount Sinai Health System and RenalytixAI and Bio-Techne Corporation, has entered into a marketing and distribution agreement with Atrys Health to expand its global footprint of Covid-19 antibody tests. As per the partnership, Atrys Health will provide Kantaro’s quantitative SARS-CoV-2 IgG antibody test kits, Covid-SeroKlir and Covid-SeroIndex, in Europe and South America, including Brazil, Chile, Colombia, Peru, Portugal, and Spain.

Oxford Immunotec has entered into a memorandum of understanding (MOU) with Green Cross Medical Science (GC MS) and MESDIA, to market the T-SPOT Discovery SARS-CoV-2 kit in South Korea for research use. Under the terms of the agreement, GC MS will market and sell, MESDIA will import, and Oxford Immunotec Korea will offer the overall backing for the kit that measures the T Cell immune response to the SARS-CoV-2 infection.

9:31 am

Coronavirus company news summary – SureScreen Diagnostics to supply 20 million rapid lateral flow tests to the UK – USC AI tool can predcoronavirus mutations

Derby-based test manufacturer SureScreen Diagnostics will supply 20 million validated Covid-19 lateral flow antigen tests to the UK government. The tests will help meet the government’s efforts to deliver rapid testing asymptomatic individuals, to break transmission chains. The tests produce results in less than 30 minutes and are the first British tests to be validated in the Public Health England (PHE) laboratory.

University of California (USC) researchers have launched a new artificial intelligence (AI) tool to counter Covid-19 mutations and hasten vaccine development. The research team has developed a machine-learning model to speed up vaccine analysis that once took months or years, and now takes only minutes or seconds to find the best preventive medical therapy.

Ottawa researchers have discovered a test that can identify Covid-19 variants in wastewater. This was based on the recently detected variant in a sample of wastewater from Barrie, Ontario. Canadian researchers have already been testing wastewater for the SARS-CoV-2 virus. Research indicates that infected individuals can shed the virus through their faeces.

10:21 am

Coronavirus company news summary – EmitBio’s light tech effective at deactivating coronaviruses – Health Canada approves Precision Biomonitoring’s SARS-CoV-2 test

Laboratory testing of EmitBio’s proprietary light technology has shown the system to be effective in deactivating multiple coronaviruses, beyond the SARS-CoV-2 virus that causes Covid-19. This includes the highly fatal Middle East Respiratory Syndrome coronavirus (MERS-CoV). The findings also indicate that the technology is likely to be effective against SARS-CoV-2 variants.

Canadian biotechnology company Precision Biomonitoring has announced that it has received approval from Health Canada for its TRIPLELOCK SARS-CoV-2 test in the 96-Well Plate format. The approval makes the ready-to-use, stable, and scalable kit for the detection of the SARS-CoV-2 virus available for immediate use in laboratories across Canada.

UK-headquartered diagnostics firm Oxford Immunotec has announced an update to the configuration of the T-SPOT Discovery SARS-CoV-2 kit. The kit is currently in its research stages and has been updated using the company’s expertise in T cell response to the SARS-CoV-2 virus.

11:31 am

Coronavirus company news summary – New Covid-19 tests approved in US and Europe – Meridian wins grant to expand SARS-CoV-2 test production

The US Food and Drug Administration (FDA) has granted emergency use authorisation to a new Covid-19 antibody test developed by Vibrant Sciences. The test, which was evaluated by scientists at the University of Denver and clinicians from the Resilience Code clinic in Denver, can predict if a patient will suffer mild or severe symptoms of the virus.

BD, a multinational medical technology company, has launched a new, approved Covid-19 blood test in Europe. The test will help hospitals identify whether infected patients will need intensive care along and ventilation, and therefore are at a higher risk of death. The diagnostic test analyses a patient’s immune system based on the levels of particular white blood cells.

CellDrop Biosciences, a University of Wyoming (UW) spinout, has received a $354,000 grant from the UW Wyoming Health and Bioscience Innovation Hub’s COVID Innovations Fund. The grant will advance the development of a sensitive and rapid antigen test for Covid-19 that can deliver results in less than three minutes. The collaboration is led by the Oakey biomedical engineering laboratory at UW and involves CellDrop Biosciences, Metrohm Raman, and the lab of Hadley Sikes, a Massachusetts Institute of Technology associate professor of chemical engineering.

Meridian Bioscience, an Ohio-headquartered diagnostic testing solutions provider, has announced that it has received a $5.5m award from the National Institute of Health (NIH) Rapid Acceleration of Diagnostics (RADxSM) initiative and an additional grant from JobsOhio, to increase the production capacity of its SARS-CoV-2 molecular diagnostic test on the Revogene platform. The funding will help expand the production of the test kits at the company’s Quebec City facility, as well as support the building of a production facility in Cincinnati, Ohio.

10:11 am

Coronavirus company news summary – Novacyt launches PCR genotyping assay portfolio to detect Covid-19 variants – Omega launches Covid-19 PCR testing for all variants

Novacyt, a biotechnology group focused on clinical diagnostics, announced the launch of a portfolio of assays under the name SNPsig to help in the diagnosis of the new SARS-CoV-2 variants. The new SNPsig portfolio complements and supports the need for PCR genotyping of variants, which emerged across the world in the latter part of 2020.

eMed, a digital health company, has announced a collaboration with the State of Colorado to administer approximately two million virtually guided BinaxNOW at-home Covid-19 rapid tests per month. The tests reveal results within minutes and are expected to aid in the safe re-opening of schools.

Omega Laboratories has launched a new suite of Covid-19 laboratory testing services, and now offers PCR testing for the disease. Omega’s Research & Development team is also hard at work validating COVID-19 oral fluid testing and laboratory-based antibody testing in the coming months.

9:39 am

Coronavirus company news summary – Roche launches new SARS-CoV-2 Rapid Antigen Test Nasal – Ellume announces $230m agreement with the US government to scale up production of Covid-19 home tests

Roche has received a CE mark for its new SARS-CoV-2 Rapid Antigen Test Nasal. The test is expected to be made available to countries that accept the CE mark products standards by mid-February 2021. The new test allows patients to self-collect samples from their nose, a simpler and quicker procedure than its previous test.

Australia-based medical technology manufacturer Ellume has struck a deal with the US Biden administration to scale up the production of its rapid Covid-19 home tests. The deal was worth $230m and will see the making and distribution of the home tests in the US. The deal also includes the purchase of 8.5 million Covid-19 tests that will be distributed across the country.

Diagnostic maker Cellex has collaborated with HealthDatix and Spartan Medical to make available its qSARS-CoV-2 Antigen Rapid Test to local, state, and federal governments. The test can be used to detect and address the B.1.1.7 and other variant strains found in the UK, US, Brazil, and South Africa.

9:47 am

Coronavirus company news summary – Arizona researchers develop smartphone-based Covid-19 test – Seegene develops Covid-19 variant test

University of Arizona researchers are currently working on a Covid-19 testing method that will utilise a smartphone microscope to analyse saliva samples and deliver results in approximately 10 minutes. Led by Jeong-Yeol Yoon, a biomedical engineering professor, the research will combine the speed of existing nasal swab antigen tests with the high accuracy of nasal swab PCR, or polymerase chain reaction tests.

OraSure Technologies has announced that its OMNIgene ORAL saliva collection kit, a product of its subsidiary DNA Genotek, was included in a US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) granted to Ambry Genetics. The healthcare company will use the saliva collection kit in its Ambry Covid-19 RT-PCR saliva test to detect and identify the SARS CoV-2 RNA.

Seegene has developed the world’s first Covid-19 diagnostic test that can screen the SARS-CoV-2 virus to identify multiple mutant variations in a single reaction. The Allplex SARS-CoV-2 Variants I Assay test integrates at least ten of its proprietary technologies, including multiplex real-time PCR method of mTOCE™. This innovative technology allows the test to detect a target specific spot where mutation occurs, enabling precise detection and differentiation of the coronavirus as well as its mutated versions with a single tube of reagent.

9:54 am

Coronavirus company news summary – Health Canada approves OMNIgene ORAL saliva collection device for Covid-19 testing – Avacta to collaborate with Bruker to assess Covid-19 test assay

OraSure Technologies, a point-of-care diagnostic tests provider, announced that its OMNIgene ORAL (OME-505) saliva collection device, a product of its subsidiary DNA Genotek, has been authorised by Health Canada for use in molecular diagnostic tests for detecting the SARS-CoV-2 virus. The move will facilitate the expansion of Covid-19 testing programmes in the country.

Mammoth Biosciences, a company that uses gene-editing technology Crispr for disease testing, announced that it has signed a co-marketing agreement with Agilent Technologies, an analytical instrumentation development and manufacturing company, to launch a CRISPR-based SARS-CoV-2 diagnostic solution. As per the partnership, the Agilent will offer its Bravo automation workstation and Mammoth its DETECTR BOOSTTM assay.

Eurofins Technologies and Eurofins Genomics have announced the launch of two validated assays for detecting B.1.1.7 (UK) and B.1.351 (South Africa) variants of the SARS-CoV-2 virus within a short turn-around time. The GSD NovaType SARS-CoV-2 Detect & ID is a real-time RT-PCR test that detects the SARS-CoV-2 virus, along with the UK and South Africa variants.

Avacta, a biotherapeutics company, has collaborated with Bruker Corporation, an analytical instrumentation manufacturer, to evaluate the Affimer-based, bead-assisted mass spectrometry SARS-CoV-2 assay that it developed with Adeptrix, an analytical reagents and assays developer. The collaboration will assess the suitability of the test as an in-vitro diagnostic product for SARS-CoV-2 infection that is expected to be run on Bruker’s MALDI-TOF instruments.

9:54 am

Coronavirus company news summary – Australia grants approval for RESOLUTE 2.0 Covid-19 test kit – Reliance signs $15m deal with BOH to distribute Covid-19 breath test kit

Advanced MedTech Holdings has announced that its RESOLUTE 2.0 direct RT-PCR test kit has been approved by Australia’s Therapeutic Goods Administration (TGA). The test kit is now authorised for use in laboratories and medical institutions across the country.

Clear Labs, a private genomics testing company, has announced the launch of Clear Dx™ Whole Genome Sequencing (WGS), the first automated WGS solution which determines the complete RNA sequence of the SARS-CoV-2 genome within 24 hours. The solution will help hospitals, public health institutions, and laboratories in identifying and tracing all SARS-CoV-2 strains more easily and quickly.

The Reliance Group has signed a $15m deal with Breath of Health (BOH), an Israeli company, to distribute the latter’s Covid-19 breath testing kits across India. As per the agreement, Reliance will be procuring hundreds of these kits systems from BOH to conduct millions of tests at the cost of $10 million per month. Reliance is also expected to lead research of the test kit in India.

9:26 am

Coronavirus company news summary – Abbott’s rapid antigen test receives CE Mark for asymptomatic screening and self-administration – Innova Medical Group starts Covid rapid test kit production in California

Abbott has received a CE Mark for its Panbio Covid-19 Ag rapid test device, which allows self-administration collection through a nasal swab. The test enables mass testing among individuals who do not show symptoms of the disease.

Fluidigm Corporation has announced that Helix Specialty Diagnostics and Genomic LTC DX have collaborated to provide Covid-19 testing with the help of the Advanta™ Dx SARS-CoV-2 RT-PCR Assay on Fluidigm’s Biomark HD system. Helix will enable sample collection, while Genomic will process and analyse the saliva samples with the Advanta Dx Assay on Biomark HD.

Innova Medical Group has officially initiated the production of its INNOVA SARS-CoV-2 Antigen Rapid Qualitative Test kit in Southern California. The company intends to expand its capacity from five million test kits per day by February to 50 million rapid test kits per day at its expanded facilities across Orange County, California.

OraSure Technologies has announced that Chronomics Limited, a biotechnology company, has selected its OMNIgene ORAL (OME-505) saliva collection device for its SARS CoV-2 PCR test. Chronomics will provide the test for UK’s Test to Release for International Travel programme.

10:01 am

Coronavirus company news summary – AnteoTech awarded up to $1.4m Queensland Government Grant to commercialise Covid-19 antigen rapid test – eMed partners with the State of Ohio to provide millions of BinaxNOW™ at-home Covid-19 rapid tests

COVAXX, a subsidiary of United Biomedical, has received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) approval for UBI SARS-CoV-2 ELISA, its Covid-19 antibody test. The test will evaluate individuals’ adaptive immune response to the SARS-CoV-2 virus, indicating either a recent or prior infection, as well as the presence of antibody levels after being vaccinated.

LumiraDx, a point-of-care diagnostic testing company, has sought approvals for the use of its SARS-CoV-2 antigen test in Japan and Brazil. The test will now be available to infected individuals in more than 30 nations globally. In addition to these authorisations, Italy has also recommended the expansion of its next-generation microfluidic technology for Covid-19 testing.

Anteotech, a medical diagnostic tools developer, has been awarded a $1.4m contract to advance the development and commercialisation of its Covid-19 antigen rapid test (RAT). The Queensland Government Grant will fund the finalisation and marketing of its proposed 15-minute point-of-care Covid-19 RAT, which harnesses Anteotech’s nanoparticle surface management technology, AnteoBind™, and a Europium particle in the detection of the SARS-CoV-2 antigen.

eMed, a digital point-of-care solutions company, has announced a partnership with the State of Ohio to supply, as well as administer approximately two million virtually guided, BinaxNOW™ at-home Covid-19 rapid tests, which can deliver results within minutes. The eMed rapid tests will enhance the reach and accessibility of home testing across organisations, states, and individuals.

10:02 am

Coronavirus company news summary – Relay Medical and Fio Corporation announce the launch of high-throughput Covid-19 mobile testing toolkit – ERBA Mannheim launches second generation SARS-CoV-2 RT-PCR assay

Relay Medical, a healthtech innovation company, and Fio Corporation, a medical equipment supplier, have announced the launch of Fionet’s mobile, high-throughput Covid-19 rapid testing solution. The modular configuration is capable of processing up to 100 Covid-19 rapid antigen tests per hour with only two Fionet devices and two personnel. The mobile testing toolkit can be deployed on-site and for real-time tracking in high-volume settings such as airports, organisations, schools, and at sports and entertainment events.

ERBA Mannheim, a healthcare solutions provider, announced the launch of the ErbaMDx SARS-CoV-2 RT-PCR kit for detecting the SARS-CoV-2 virus. Its UK-based development team has carefully designed a new assay that will help improve the detection of the virus with ease and make possible its storage and transportation at room temperature.

Two natural healthcare providers, Virocule and Dr Ho Now Health Products, have signed an exclusive consumer and retail distribution agreement for the supply of Virocule’s ANOSMIC COVID-19 Smell Tester across major retail stores in Canada in the next few weeks. Authorised for sale by Health Canada, the rapid, early detection, screening device is currently available on Virocule’s website.

11:01 am

Coronavirus company news summary – LooK SPOT antigen test receives CE-IVD clearance for Europe – Cue’s molecular, point-of-care Covid-19 tests now available in ten US states

Applied DNA Sciences has announced that its Linea™ Covid-19 Assay Kit is able to detect multiple Covid-19 variants. The variants were identified as part of the safeCircleTM pooled surveillance testing service provided by the company through its Assay Kit.

Laipac Technology, an IoMT (Internet of Medical Things) developer, has recieved CE IVD clearance for its LooK SPOT Covid-19 antigen rapid test. The LooK test is a smartphone-based diagnostic device with a lateral flow immunoassay that detects nucleocapsid protein from SARS-CoV-2 nasal swab samples.

Cue Health, a medical diagnostic products manufacturer, has announced that its molecular, point-of-care Covid-19 tests will be distributed across five additional states, including Colorado, Rhode Island, Pennsylvania, Minnesota, and Utah, as part of the joint $481m programme initiated by the US Department of Health and Human Services (HHS) and the Department of Defence (DOD). The tests are already distributed across AlaskaFloridaLouisianaNew Jersey and Texas.

9:53 am

Coronavirus company news summary – Eurobio Scientific expands its range of Covid-19 tests – Quest Diagnostics granted CDC contract to sequence Covid-19 gene variants

Eurobio Scientific has announced the expansion of its entire range of Covid-19 tests. This included its new proprietary antigenic test called the EBS 10-20 Ag Test, which can detect the SARS-Cov-2 antigen with the help of a nasopharyngeal ergonomic swab. The test also helps yield results within just 10 minutes.

Quest Diagnostics has announced an agreement with the Centres for Disease Control and Prevention (CDC) to offer genomic sequencing to identify new SARS-CoV-2 mutations, thereby providing insights into the prevalence and transmission patterns of the virus in the US. The goal of the collaboration is to conduct a large-scale longitudinal genomic survey of the SARS-CoV-2 virus using random collected samples.

Neuberg Diagnostics has received approval from the Indian Council of Medical Research (ICMR) to conduct Covid-19 tests across Andhra Pradesh, New Delhi, Kerala, and Tamil Nadu. The laboratories will be established in Noida, Visakhapatnam, Salem and Kozhikode, with capacities to process approximately 7,000 reverse transcription polymerase chain reaction test samples each day.

9:26 am

Coronavirus company news summary – Rapid blood test identifies Covid-19 patients at high risk of severe disease – Israeli company develops ‘breathalyser’ Covid-19 test with 98% accuracy

Scientists at the Washington University School of Medicine in St Louis have revealed a rapid blood test that can predict severe complications and even deaths in hospitalised Covid-19 patients. The study involved approximately 100 infected patients that were newly admitted to the hospital. The test measures levels of mitochondrial DNA, a unique type of DNA molecule that normally resides inside the energy factories of cells. Mitochondrial DNA spilling out of cells and into the bloodstream is a sign that a particular type of violent cell death is taking place in the body.

Scentech Medical, an Israeli-based breath test diagnostics company, has developed a new and more accurate test that can screen for Covid-19 in just a few minutes and with 98% accuracy, reports Times of Israel. The test operates like a breathalyser test used by police. It is not yet authorised for use or approved by the Food and Drug Administration (FDA).

Eurofins, an international group of laboratories providing testing and support services, has announced a number of new initiatives aimed at increasing testing capacity of the SARS-Cov-2 virus. As part of this, it will launch NovaType, a SARS-CoV-2 RT-PCR assay, for identifying B.1.1.7 and B.1.351 variants. NovaType is already available in Germany and will be made available in many European countries for trial.

Global WholeHealth Partners Corp has encouraged the increase in research and development into Covid-19 SARS 2 testing. FDA authorised Covid-19 point of care serology tests can get results within minutes. Global WholeHealth Partners expects to distribute these tests to urgent care centres, hospitals, and others to help curb the spread of the SARS-CoV-2 virus

9:45 am

Coronavirus company news summary – Cepheid receives Health Canada license for SARS-CoV-2, Flu A, Flu B and RSV combination test – SML Genetree receives FDA EUA for Ezplex SARS-CoV-2 G real-time PCR Kit

Chembio Diagnostics has received CE certification for its DPP SARS-CoV-2 Antigen and IgM/IgG test systems. The company has also entered into a distribution agreement with Luas Diagnostics, to start selling the products immediately in the UK and Ireland.

Cepheid, a molecular diagnostics company, has been granted a Health Canada license for its Xpress SARS-CoV-2/Flu/RSV, a rapid molecular combination diagnostic test that can detect SARS-CoV-2, Flu A, Flu B, and RSV infections from a single sample. The test can deliver results in approximately 36 minutes and is now made available in Canada and can also be used in laboratories and at point of care facilities.

SML Genetree announced that it has been granted emergency use authorisation (EUA) by the US Food and Drug Administration (FDA) for its Ezplex SARS-CoV-2 G Kit, a real-time molecular diagnostic test that helps in detecting RNA from the SARS-CoV-2 virus from nasal and oral swabs, sputum specimens, as well as for use in pooled samples.

9:59 am

Coronavirus company news summary – Biomerica’s 15-minute Covid-19 Rapid Antigen Test receives CE Mark – Abbott fulfils US government purchase of 150 million BinaxNOW Covid-19 Rapid Tests

The US Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) to ADVAITE’s RapCov Rapid COVID-19 Test. The biotech company is among the handful of manufacturers to be granted EUA for a point-of-care serology test.

Biomerica, a global biomedical company that manufactures diagnostic products, has received CE mark certification for its new Covid-19 Rapid Antigen Test that helps in detecting the SARS-Cov-2 virus. The company has already received its first orders and plans to ship the tests in the weeks ahead and will now market its product across the Europe and outside the US.

Abbott has fulfilled the US government’s purchase order of 150 million BinaxNOW Covid-19 Ag tests. These tests were distributed across the Department of Health and Human Services (HHS) to states, territories, nursing homes, historically black colleges and universities (HBCUs), assisted living facilities, home health and hospice agencies, and the Indian Health Service. The company will supply 30 million additional tests through March under a new government order.

9:48 am

Coronavirus company news summary – Quanterix receives FDA emergency use authorisation for SARS-CoV-2 N Protein Antigen Test – SourceBio signs deal to process high street Covid tests

T2 Biosystems, an in vitro diagnostics company,  has announced that its T2SARS-CoV-2™ Panel is capable of identifying multiple variants of the SARS-CoV-2 virus. This includes the new virus strain that recently showed up in the UK, US, and South Africa.

Victory Square Health has announced that the Brazilian Health Regulatory Agency (ANVISA) has permitted the company to begin sales, marketing, and distribution of its Safetest 15 Minute Covid-19™ Rapid Test assay in Brazil, which helps in detecting IgG and IgM antibodies against the SARS-CoV-2 virus.

Quanterix has announced that the US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to its Simoa® SARS-CoV-2 N Protein Antigen Test to be run on the Simoa HD-X Analyzer®, an automated high-throughput immunoassay instrument.

SourceBio International, a clinical laboratory company, has struck a deal with an unnamed high street retail and pharmacy group to offer laboratory-based testing services to support increased testing across UK stores. Under the terms of the initial year’s agreement, SourceBio will provide Covid-19 PCR Testing services from its laboratory facility at Nottingham.

9:14 am

Coronavirus company news summary – Everlywell and Gingko Bioworks sign agreement to distribute rapid antigen tests – UK orders first tests for asymptomatic Covid-19 testing

Everlywell, a digital health company, and Ginkgo Bioworks, a life sciences company, have entered into an agreement to distribute Access Bio’s CareStart™ Covid-19 antigen test, which has been approved by the US Food and Drug Administration (FDA), to government offices, workplaces, schools, clinics and health plans. The CareStart™ Covid-19 antigen test includes a disposable rapid antigen testing lateral flow device that can detect the SARS-CoV-2 infection just 15 minutes.

The FDA is monitoring the potential impact of Covid-19 viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorised SARS-CoV-2 molecular tests. It believes the risk that Covid-19 mutations will impact overall testing accuracy is low. The agency has reminded clinical laboratory staff and health care providers about the risk of false negative results with all laboratory tests, including molecular tests. Laboratories should expect some false results to occur even when very accurate tests are used.

Matt Hancock, the Health and Social Care Secretary of the UK, has announced that the government has ordered for two million of the first British-manufactured rapid lateral flow antigen tests for use in asymptomatic testing, which will be validated by Public Health England. SureScreen Diagnostics, a bespoke diagnostic solutions manufacturer, will provide the two million lateral flow tests, which yields results in less than 30 minutes.

9:54 am

Coronavirus company news summary – ForaCare Suisse releases rapid Covid-19 antigen test – Spectrum Solutions partners with Steribottle for saliva-based Covid-19 testing in the UK

ForaCare Suisse has developed the FORA COVID-19 Antigen Rapid Test, which it says provides accurate and easy-to-interpret test results for detecting an acute infection of the virus within 15 minutes. The test does not require laboratory testing and can be administered by trained experts. Clinical results indicate that the test has a 95.8% sensitivity and a 98.6% specificity, however tests have only been carried out on a small number of samples thus far.

Spectrum Solutions has partnered with Steribottle, a disposable sterile baby bottles manufacturer and distributor, to offer its SDNA-1000 saliva collection device to comply with Covid-19 testing directives in the UK. The Spectrum Solutions SDNA-1000 Saliva Collection Device was the first saliva-based solution to receive the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for COVID-19 testing.

Twist Bioscience will supply the US Centers for Disease Control and Prevention (CDC) with a customised version of the Twist SARS-CoV-2 Synthetic RNA Controls for use in the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay tests. The tests are designed to detect influenza A, B and SARS-CoV-2 from one sample.

Clear Labs has broadened the scope of its partnership with Integrated DNA Technologies (IDT), a supplier of custom nucleic acids, to automate and improve the accuracy of Covid-19 testing. Clear Labs’ sequencing platform for diagnosing the SARS-CoV-2 virus employs IDT primers as part of its solution.

9:54 am

Coronavirus company news summary – JOYSBIO’s Covid-19 antigen test kit detects new strain – Europe approves Seegene’s saliva-based Covid-19 test kit

JOYSBIO Biotechnology has developed the SARS-CoV-2 Antigen Rapid Test Kit, which is capable of detecting the new Covid-19 strain found in the UK and US. Referred to as SARS-CoV-2 VUI 202012/01, Variant of Concern 202012/01, VOC-202012/01, or lineage B.1.1.7, was identified first in England during the autumn of 2020, and later in France and the US as well.

A Prince of Songkhla University team in Thailand have developed a new Covid-19 test kit that shows 99% accuracy in detecting antibodies in the blood within 15 minutes. The kit has been approved by Thailand’s Food and Drug Administration (FDA) and will be produced at a rapid pace of 100,000 kits per day.

Sensus Healthcare has announced that Holy Name Medical Centre in Teaneck, New Jersey has acquired a Sensus low-dose radiation therapy system for treating pneumonia in Covid-19 patients. The SRT-100+™ and SRT-100 Vision™ systems are portable and can allow immediate treatment in an intensive care unit rather than having to transport patients to cancer treatment centres that increase the chances of exposure to the SARS-CoV-2 virus.

Seegene has been granted CE-IVD permits in Europe for its two in-vitro diagnostic saliva-based test kits that help in detecting the Covid-19 disease. The two test kits, Allplex SARS-CoV-2 Assay and Allplex SARS-CoV-2/FluA/FluB/RSV Assay, can detect four target genes for Covid-19 and simultaneously identify the new coronavirus and flu respectively.

10:01 am

Coronavirus company news summary – New Covid-19 RNA test from the UK gives accurate results within minutes – Shuwen obtains CE-IVD mark for Covid-19 test kit

Researchers from the UK University of Birmingham have developed a Covid-19 RNA test that can deliver accurate results within five minutes. The test uses an amplification technique called Exponential Amplification Reaction (EXPAR) which uses very short, single strands of DNA for the replication process, which can be completed in a matter of minutes.The entire test can be run on standard laboratory equipment at lower temperatures compared to PCR tests, which require higher temperatures to separate out strands of DNA as part of the amplification process.

Nirmidas Biotech has announced its second Emergency Use Authorization (EUA) approval from the US Food and Drug Administration (FDA) for its Covid-19 rapid antibody IgG/IgM test. The test is now available at point-of-care settings. The MidaSpot™ COVID-19 Antibody Combo Detection Kit uses a fingerstick serology test to detect antibodies against the receptor‐binding domain (RBD) antigen on the surface of the SARS-CoV-2 virus.

Trinity Biotech has achieved a CE mark for its Captia™ SARS-CoV-2 IgG ELISA antibody test. Trinity has launched the test across all European Union (EU) countries as well as other countries that approve the CE mark.

Shuwen Biotech has been granted the CE-IVD mark for its SARS-COV-2 RT-PCR Kit. The Chinese government agency has also granted the company clearance for exporting the kit. The kit is currently available in Europe for distribution and in other regions that recognise the CE certification.

10:02 am

Coronavirus company news summary – Health Canada authorises CytoSorb for hospitalised Covid-19 patients – NextGen announces rapid breath test for Covid-19 detection to evaluate efficacy of vaccines

Enzo Biochem has received an expansion of its Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) to conduct tests on pooled samples that contain up to five individual swab specimens. The tests will be conducted on the AMPIPROBE® SARS-Cov-2 Test System using three different platforms including Enzo’s GENFLEX™ automated high-throughput platform.

CytoSorbents Corporation has received medical device authorisation from Health Canada to import, sell, and use its CytoSorb blood purification technology to treat hospitalised Covid-19 patients. The company is expected to collaborate with ebbtides medical, a specialty distributor of medical products, to accelerate the availability of the therapy.

NextGen Biomed, has received approval from the Shamir Medical Centre (Asaf Harofe) Review Board for a clinical trial of its rapid breath test to detect the SARS-CoV-2 virus, as well as evaluate the efficacy of vaccines. The company will monitor the IgM and IgG antibody among those getting vaccinated for Covid-19, to assess the effectiveness of different treatments.

Innova Medical Group (IMG) has acquired California-based MPS Medical, to expand its Covid-19 rapid test kit manufacturing capacity in the US. MPS Medical is an FDA registered medical device manufacturer known for high-quality medical devices. As per the new ownership, MPS Medical will aggressively ramp up capacity for multi-millions of test kits per day in California, anticipating greater demand for domestic and international customers.

9:52 am

Coronavirus company news summary – Scientists in Turkey develop ten second Covid-19 test with 99% accuracy – Emergency departments in North Wales join instant testing study for Covid-19

Researchers at the Bilkent University National Nanotechnology Research Center in Turkey have developed a ten second Covid-19 test named Diagnovir that can deliver results with 99% accuracy. The test uses nanotechnology to detect Covid-19 pathogens using fluorescent signal. A positive result is delivered within five to ten seconds, while negative result can take up to 20 seconds.

The Indian Council of Medical Research-Regional Medical Research Centre (ICMR-RMRC) has conducted a study to evaluate the use of saliva as a Covid-19 diagnostic sample, instead of nasal and throat swab samples. The study showed that the results using saliva samples were comparable with those using nasal samples. Use of saliva makes sample collection easier and also reduces the chances of infection among healthcare workers. The study compared 74 samples of Covid-19 patients using nasal swabs and saliva specimens.

Emergency departments in North Wales are joining a UK study that will assess the effectiveness of Covid-19 tests that can give instant results. The Facilitating Accelerated Clinical Evaluation of Novel Diagnostic Tests for Covid-19 (FALCON) study will assess the accuracy of new and faster tests, as current tests take up to 48 hours to deliver results. The study is being conducted by researchers across the United Kingdom with Manchester University NHS Foundation Trust acting as the sponsor for the study.

8:16 am

WHO says new variant of Covid-19 virus in UK not out of control

The World Health Organisation (WHO) said that the new variant of Covid-19 virus discovered in the UK with a higher transmission rate is ‘not out of control’ and could be contained with the help of existing measures.

Earlier, British Health Secretary Matt Hancock had claimed that the variant was out of control, while officials said that it was 70% more transmissible than the main strain, AFP reported.

The new agency quoted WHO emergencies chief Michael Ryan as saying in a press conference: “We have had a much higher (contamination rate) at different points in this pandemic and we’ve got it under control.
“So this situation is not in that sense out of control. But it cannot be left to its own devices.”

Earlier this week, the UK found that the new variant identified through Public Health England’s genomic surveillance could spread faster.

WHO Director-General Dr Tedros Adhanom Ghebreyesus said in a media briefing: “In the past few days, there have been reports of new variants of the Covid-19 virus in South Africa and the United Kingdom. Viruses mutate over time; that’s natural and expected.”

“WHO is working with scientists to understand how these genetic changes affect how the virus behaves.”

9:47 am

Coronavirus company news summary – Biocogniv and Research Partners study an AI tool to assist clinical labs in Covid-19 testing – CSIR-CCMB and Apollo hospitals collaborate on rapid and safe Covid-19 testing kits

Applied BioCode has received Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for the use of its BioCode® SARS CoV-2 molecular diagnostic assay along with pooled patient samples. The EUA permits BioCode to carry out pooled testing of up to five individual patient samples suspected to be infected with the SARS-CoV-2 virus.

Advanced MedTech Holdings (AMTH), a Singapore-based medical technology firm, announced that the RESOLUTE 2.0 test kit it co-developed with A*STAR and DSO National Laboratories has been authorised by the Health Sciences Authority (HSA) for deep-throat saliva (DTS) SARS-CoV-2 testing. AMTH holds the manufacturing and distribution rights for the test kits, which is easy-to-use and reduces the risk of virus spread.

Researchers from the University of Vermont and Cedars-Sinai have collaborated to study the performance of a Biocogniv’s COVID™ software. The team found that the artificial intelligence (AI) tool had high accuracy in predicting the probability of Covid-19 infection using routine blood tests, which can help hospitals reduce the number of patients referred for scarce PCR testing.

The Indian Council for Scientific and Industrial Research-Centre for Cellular and Molecular Biology (CSIR-CSMB) and Apollo Hospitals have collaborated to jointly manufacture and commercialise a dry swab test, Direct Amplification rapid RT-PCR (DArRT-PCR) for Covid-19 detection. The DARrT-PCR is cost effective and will be made available across India through the Apollo Hospitals network.

9:52 am

Coronavirus company news summary – LabCorp receives FDA authorisation to sell at-home Covid-19 collection kits through retail – ams and Senova inaugurate production line for Covid-19 antibody digital rapid tests

LabCorp has been granted Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for the Pixel by LabCorp™ Covid-19 Test Home Collection Kit to be made commercially available without requiring prescription. The approval will allow LabCorp to distribute the at-home kits through retail channels.

Roche and Moderna have announced a partnership to utilise the Elecsys® Anti-SARS-CoV-2 S antibody test in Moderna’s mRNA-1273 vaccine research trials. This will to measure the SARS-CoV-2 antibodies of trial participants to establish a correlation between vaccine-induced protection and anti-receptor binding domain (RBD) antibodies. Roche was recently granted EUA for the Elecsys® antibody test.

Ellume, a digital diagnostics company, has announced that its rapid, at-home Covid-19 antigen test demonstrated 96% accuracy in a US clinical study conducted across five states. The Ellume Covid-19 home test is considered to be easy to use and safe for detecting the SARS-CoV-2 nucleocapsid antigen among those aged two years and above. The rapid self-test delivers results in 15 minutes or less.

ams, a supplier of sensor solutions, and Senova, an in-vitro diagnostic medical devices manufacturer, have announced the opening of a production line for lateral flow tests that will help detect antibodies from the SARS-CoV-2 virus. The cost-effective platform was developed in less than nine months and will process the data in a secure medical cloud.

10:06 am

Coronavirus company news summary – Bluejay and Toray collaborate to develop point-of-care test for Covid-19 patient triage – ixlayer’s technology selected for Covid-19 research collaboration

Meridian Bioscience, a diagnostic testing solutions provider, has applied for Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for its SARS-CoV-2 molecular diagnostic test on the Revogene® platform. The test can detect the SARS-CoV-2 virus among individuals in 47 minutes and can be integrated in any laboratory or health system.

Bluejay Diagnostics and Toray Industries have entered into a collaborative agreement to develop a minimally invasive, point-of-care test to assess the progress of Covid-19 in high-risk patients. The Symphony™ IL-6 combines microfluidics and nanotechnology to create point-of-care tests in liquid biopsies.

ixlayer, a healthtech solutions provider, announced that its technology has been selected for a Community Alliance to Test Coronavirus at Home (CATCH) Study initiated by the Chan Zuckerberg Biohub and Stanford University. The study intends to conduct large-scale research on the testing and tracking of Covid-19 in the greater San Francisco Bay Area.

CorVent Medical has received EUA from the FDA for its RESPOND-19™ ventilator, which is able to be used by multiple patients. This new category of ventilators is designed for expanding critical care ventilation capacity to hospitals struggling with increasing number of Covid-19 patients suffering from acute respiratory distress syndrome (ARDS). The respiratory system is cost effective, reusable for multiple patients, and is commercially available in the US.

9:42 am

Coronavirus company news summary – Thermo Fisher scientific releases new CE-marked Covid-19, flu A/B, RSV combo kit – Everlywell signs agreement to distribute Cellex’s Covid-19 rapid antigen test

NOWDiagnostics has announced that encouraging test results from its ADEXUSDx® Covid-19 antibody test has helped the company to file for Emergency Use Authorisation (EUA) with the US Food and Drug Administration (FDA). The antibody test delivered 100% sensitivity and 100% specificity in a Biodefense and Emerging Infections Research Resources Repository (BEI Resources) study.

Thermo Fisher Scientific has received the European CE-mark for its TaqPath Covid-19, flu A/B, RSV combo kit for the diagnosis of the SARS-CoV-2 virus, influenza A/B and respiratory syncytial virus (RSV) A/B infections. Laboratories can now run a single test for detecting all these infectious diseases and monitor the progress and spread of the diseases in just three hours.

Victory Square Technologies has struck two manufacturing, sales and distribution agreements to supply White Label Covid-19 Rapid Antibody and Antigen Tests through the company’s global distribution network, as well as through its ecommerce platforms. The agreements will also allow Victory Square to manufacture and market other White Label diagnostic tests on its soon-to-be launched telehealth platform.

Everlywell, a digital health company, has struck a distribution agreement with Cellex, a diagnostics manufacturer, to distribute Cellex’s Covid-19 rapid antigen test for use by public health agencies and professionals. The point of care rapid antigen test still awaits emergency use authorisation by the FDA.

11:53 am

Coronavirus company news summary – FDA authorises first Covid-19 and flu combination test for use with home-collected samples – CRISPR-based Covid-19 test uses smartphone cameras to spot virus RNA

The US Food and Drug Administration (FDA) has authorised the first diagnostic test for at home sample collection and detection of both Covid-19 and influenza A and B (flu). The Quest Diagnostics RC COVID-19 +Flu RT-PCR Test is now eligible for prescription use along with the Quest’s Self-Collection Kit for COVID-19 +Flu for individuals suffering with respiratory viral infection that may be consistent with Covid-19.

Scientists from the University of California Berkeley and Gladstone Institutes have developed a new CRISPR-based Covid-19 diagnostic test that uses smartphone cameras to detect a positive or negative result in 30 minutes. Unlike other tests, this one allows doctors to monitor the severity of the disease in patients and how contagious they may be depending on the number of virus particles in a sample.

Achiko and Udayana University have collaborated to conduct Covid-19 mass testing in Bali. The partners will study the acceptance and feasibility of mass testing and its effects on the healthcare industry, consumer and business confidence. As per the research agreement, the testing will be conducted across three islands, Nusa Penida, Nusa Lembongan and Nusa Ceningan.

ADVAITE, a biotech company, has received a CE mark clearance for its Covid-19 rapid response IgG antibody test, RapCov™, to help efforts to curb the spread of the virus. The company is collaborating with OBELIS in the Europe, as an authoritative representative, to expand and market the diagnostic testing kits.

9:51 am

Coronavirus company news summary – AXIM develops ELISA-based neutralising antibody diagnostic test for Covid-19 – ixlayer and CIC Health partner to expand Covid testing in US schools and universities

Intrivo Diagnostics announced that it has entered into a national distribution agreement with Concordance Healthcare Solutions and NDC to start the distribution and commercialisation of New Jersey-based Access Bio’s CareStart™ line of coronavirus testing products throughout the US. The move aimed at broadening the reach and access to CareStart portfolio of Covid-19 diagnostic products.

AXIM Biotechnologies has developed and filed a patent for an enzyme-linked immunosorbent assay (ELISA)-based diagnostic test for detecting SARS‐CoV-2 neutralising antibodies. The filing is AXIM’s fourth Covid-19 neutralising antibody-based patent application.

Drawbridge Health and the Medical Research Council Epidemiology Unit at the University of Cambridge have collaborated to investigate the use of the OneDraw™ Blood Collection Device as a method of blood sample collection for assessing the prevalence of a prior Covid-19 infection. The large-scale surveillance study enables non-contact blood collection and safe delivery of samples to clinical testing laboratories.

ixlayer, a technology-based diagnostic solutions provider, has partnered with CIC Health to expand the access of Covid-19 testing to more US schools and universities. CIC Health will use ixlayer’s COVID-19 Clinical Testing Platform to provide testing services including distribution of the tests, coordinating with labs and tracking patients, to school districts and universities across the nation.

9:51 am

Coronavirus company news summary – Oxford Immunotec signs agreement with RIKEN Genesis to market the T-SPOT Covid kit – Selfdiagnostics to submit request for authorisation

Oxford Immunotec, has entered into a distribution agreement with RIKEN Genesis in Japan. As per the agreement, RIKEN will have exclusive distribute Oxford’s T-SPOT Discovery SARS-CoV-2 kit. The kit has been developed to detect and measure SARS-CoV-2 specific T cells, thereby offering more insight into immunity responses to the SARS-CoV-2 virus.

Chembio Diagnostics it has received a $12.7m contract from the Biomedical Advanced Research and Development Authority (BARDA), for developing and procuring Emergency Use Authorisation (EUA) from the US Food and Drug Administration (FDA) for its rapid, multiplex DPP Respiratory Antigen Panel point-of-care test system. The test is designed to provide simultaneous, discrete, and differential detection of Influenza A, Influenza B and SARS-CoV-2 antigens from a single patient respiratory specimen. It is hoped to assist in the containment of Covid-19 cases during flu season.

TNG Dx has partnered with the US Department of Health and Human Services and eTrueNorth to create a rapid RNA extraction protocol as part of a community-based surveillance initiative. The new methodology will help clinical laboratories to deliver Covid-19 analysis and results faster, thereby affordable increasing the number of tests they can process.

European-based Selfdiagnostics is planning on submitting a request for authorisation on for its at-home molecular diagnostic test to help in the detection of the SARS-CoV-2 virus. Selfdiagnostics rapid PCR is the first multifunctional test that is able to detect Covid-19 and influenza from one nasal swab.

10:02 am

Coronavirus company news summary – Roche receives FDA EUA for new semi-quantitative test – ams wins Federal funding in Austria to bolster pandemic control

Roche has announced that its Elecsys® Anti-SARS-CoV-2 S antibody test has recieved emergency use authorisation (EUA) from the US Food and Drug Administration (FDA). The semi-quantitative blood test will be used to measure antibody levels among individuals who have been exposed to the SARS-CoV-2 virus. This could help to guide the allocation of plasma donations from recovered Covid-19 patients to those who are seriously ill with the virus, by narrowing down those with the highest antibody levels.

GENETWORx Labs have launched a diagnostic Flu A-B/COVID-19/RSV combination test to help in the early detection of all the three separate viruses from a single sample. The US has reported exploding coronavirus cases across the country, with the government looking to fast-track testing in the upcoming days in winter.

The Austrian Federal Ministries for Transport, Innovation, Technology, and Digital and Economic Affairs has awarded funding to ams, a high-performance sensor solutions supplier, to fast-track the development of a cloud-based, highly-sensitive, Lateral Flow Test (LFT) that will help in the detection of the SARS-CoV-2 virus. Based on the pre-existing ams spectral sensor AS7341L, ams says the test will offer results in 15 minutes.

Multi Radiance Medical is looking to apply for FDA EUA, after the completion of its super pulsed laser therapy technology intended to improve the respiratory condition of critical Covid-19 patients. The trial data found that MRM’s laser therapy reduced invasive intubation time by 18% and mechanical ventilation time by 23%.

9:52 am

Coronavirus company news summary – Cell ID unveils portable genetic test for Covid-19 – LGC submits EUA for high-throughput PCR testing system

Cell ID, a Singapore-based med-tech company, has announced that its portable genetic Quiz PCR Biochip test can be conducted via saliva specimen or nasal swab to detect the SARS-CoV-2 virus within minutes. The company also claims that it is commercially ready and can be used via an app on a laptop to conduct tests anytime, anywhere.

Empower has entered into a North American Re-Seller and Distribution Agreement with API Pharma for its rapid antigen test and rapid antibody test, for which it has submitted a request for Emergency Use Authorisation (EUA) to the US food and Drug Administration (FDA).

LGC has submitted a request for EUA to the FDA for its high-throughput RT-PCR testing system to detect the SARS-CoV-2 virus. LGC’s high-throughput RT-PCR workflow can deliver approximately 35,000 tests per day with just one scaling system.

The Wyss Institute for Biologically Inspired Engineering at Harvard University has licensed its eRapid technology to The iQ Group Global for Covid-19 diagnostic applications. The Australian consortium intends to integrate the technology with its transistor technology for specific and sensitive SARS-CoV-2 testing to address gaps in the development of Covid-19 diagnostics.

9:23 am

Coronavirus company news summary – Immunodiagnostic Systems launces two rapid Covid-19 tests – UBC-Providence scientists join WestJet and YVR for Covid-19 testing study

Immunodiagnostic Systems has announced the availability of two SARS-CoV-2 antigen rapid test kits in the UK, EU and other countries that accept the CE mark. The tests can be performed by all healthcare professionals, using direct nasopharyngeal swab samples that provide results within 15 minutes.

The Indian Council of Scientific & Industrial Research – Centre for Cellular and Molecular Biology (CSIR-CCMB) has received Indian Council of Medical Research (ICMR) approval to commercially use the dry swab RNA-extraction free testing method for detecting the SARS-CoV-2 virus. The move allows health authorities to scale testing and access at lower costs compared to other conventional RT-PCR tests, with a quick turnaround time.

The University of British Columbia (UBC) and Providence Health Care have collaborated to launch the WestJet-YVR Covid-19 Testing Study. A first-of-its-kind in Canada, the study will investigate Covid-19 rapid testing to create more effective ways to test departing passengers at the Vancouver International Airport (YVR).

Veritas Intercontinental has launched a new service that analyses individual cients’ response to Covid-19 through whole genome or whole exome sequencing. The objective of the saliva-based sample analysis is to personalise treatment for individuals and avoid complications. People can avail the service through Veritas or Veritas partner networks, and those who have their genome sequenced through the myGenome by Veritas can receive the Covid-19 study without additional sample submission.

9:44 am

Coronavirus company news summary – Biolidics inks deal to distribute Chinese biotech’s Covid-19 test kits – Alberta launches rapid testing pilot

Salient Bio, a UK diagnostic firm, has launched the fastest robotics-driven Covid-19 mass testing platform, reports Pharma Phorum. The company claims that the platform can provide results with a 99% accuracy. There are different mass testing approaches, one being the breath test which has prompted the trial of the Microtox device. The UK is also conducting a mass trial programme at Liverpool, which has a surge in virus infections.

BASE10 Genetics and DNA Link have announced a collaboration to evaluate the use and efficacy of DNA Link’s AccuFind COVID-19 IgG antibody test in a point-of-care healthcare setting. Although Covid-19 cases and mortality rates have witnessed a recent surge in the US, many individuals have also recovered from the infection.

Biolidics Limited has entered into a deal with the Chinese biotech company, JOYSBIO, to develop and/or distribute the latter’s certified SARS-CoV-2 Antigen Rapid Test Kit. Under the terms of the agreement, Biolidics will distribute the kits worldwide for a period of one year from the date of the agreement.

Alberta Health Minister Tyler Shandro, the health minister has announced that the province is launching rapid Covid-19 tests in December to fast-track testing of all individuals showing Covid-19 symptoms and to track down everyone infected within the territory. Shandro stated that almost 100,000 PanBio and Abbott IDNow rapid-test kits were available for distribution and will be sent as a test pilot across the province to curb the spread of the disease.

11:05 am

Iceni test determines Covid-19 infection rate

Iceni Diagnostics has developed a rapid Covid-19 test that it claims can determine whether or not a patient is actually infectious.

The lateral flow assay is designed to react to live, intact virus, unlike the most other tests, which will react to any form of viral genetic material or protein. The test works by detecting the viral cells’ interaction with sugars that surround human cells.

Manchester Institute of Biotechnology professor Dr Rob Field said: “We believe this technology could change the way we tackle Covid. Where we can quickly tell who is infectious, we can make much better decisions about whether we go to work, school or university and more efficiently manage quarantine periods following international travel.”

Iceni is set to trial its technology in care homes through Cambridge Clinical Laboratories over the coming weeks.

9:17 am

Coronavirus company news summary – Co-Diagnostics CoSara receives clearance for Saragene in India – Abionic launches first Covid-19 severity test

Co-Diagnostics subsidiary CoSara Diagnostics has received Central Drugs Standard Control Organization (CDSCO) clearance in India to both manufacture and sell its Saragene™ Covid-19 2-gene multiplex RT-PCR test as an in vitro diagnostic (IVD) for the detection of the SARS-CoV-2 virus.

Kantaro Biosciences, a joint venture between the Mount Sinai Health System and RenalytixAI, has received US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its COVID-SeroKlir, a semi-quantitative SARS-CoV-2 IgG antibody test kit. The antibody test kit is regarded as different from other kits in determining the presence of the exact level of IgG antibodies. It is being manufactured at a capacity of up to 10 million tests per month.

Swiss medtech company Abionic has launched the cSOFA score, a Covid-19 severity test tool that measures medical criteria and clinical deterioration among Covid-19 patients. This enables healthcare professionals to decide the course of treatment for different patients and whether they need to be assigned to intensive care units, general wards, or discharged, thereby freeing up the capacities at hospitals.

CaptiGen has announced the development of CaptiSwab, knitted sterile swabs that can help collect clinical samples for the microbial detection of the SARS-CoV-2 virus through RT-PCR, and next-generation sequencing (NGS). CaptiSwab is designed to optimise accuracy and extraction from the device.

9:10 am

Coronavirus company news summary – RapidRona self-collection kit awarded EUA – Genomica launches new PCR test to differentiate Covid-19 from other respiratory viruses

RapidRona has recieved Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its Covid-19 sample self-collection kit. The company looks to enhance rapid access to in vitro diagnostic testing for Covid-19 as the disease stretches into the flu season.

Cepheid has received CE-IVD marking for its Xpress SARS-CoV-2/Flu/RSV, a rapid molecular test that helps detect Covid-19, Flu A, Flu B, and RSV virus from one sample. The test, which delivers results in 36 minutes, received emergency use authorisation from the FDA in September 2020, and is now available in European markets.

The FDA notified the entry of two ender Covid-19 tests, ender LAB and ender MASS, into the US market. ender diagnostics North America, the US subsidiary of ender diagnostics, is ready to deliver the 30-minute rapid, reliable, and cost-effective Swiss-developed Covid-19 testing kits to diagnostic laboratories to increase testing capacities.

Genomica, a Spanish molecular diagnostic company, has launched a new PCR test to detect and differentiate between Covid-19 and other respiratory viruses such as Influenza A and B and respiratory syncytial virus (RSV). The new test has already obtained CE marking, is available across diagnostic laboratories and hospitals.

9:28 am

Coronavirus company news summary – ARUP Laboratories announces the availability of a combined test for Covid-19, Influenza, and RSV – GE Healthcare announces first x-ray AI to help assess endotracheal tube placement for Covid-19 patients

ARUP Laboratories, a University of Utah non-profit enterprise, has announced the availability of a combined test for the detection and differentiation of the SARS-CoV-2 virus, influenza and/or respiratory syncytial virus (RSV) among those suffering with respiratory conditions consistent with Covid-19. It will be avaliable to clients in the US.

LifeLabs, a digital health systems provider,  has announced the launch of its Covid-19 antibody test, which helps in identifying prior exposure to the SARS-CoV-2 infection. Approved by Health Canada, the serology test does not diagnose acute Covid-19 infection but helps in identifying a prior infection, even in asymptomatic individuals.

Zymo Research announced that its quick-DNA/RNA Viral MagBead Kit had received the CE IVD mark for the distribution of the kit in the European Union (EU). The kit will be used for the purification of viral DNA/RNA, such as the SARS-CoV-2 virus, as well as other pathogenic sample types. The kit forms part of the several US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) SARS-CoV-2 test workflows developed by companies.

GE Healthcare has developed an artificial intelligence (AI) algorithm to help clinicians weigh Endotracheal Tube (ETT) placements, an important procedure while critically ill Covid-19 patients are placed on ventilation. One of the five AI solutions included in GE Healthcare’s Critical Care Suite 2.02 helps radiologists in automating processes and prioritising cases, thereby cutting down average review time for up to eight hours.

9:35 am

Coronavirus company news summary – COVAS tool helps predict Covid-19 outcomes – Dubai introduces new saliva test to detect Covid-19 in kids

Ortho Clinical Diagnostics has announced that its CE-marked VITROS® SARS-CoV-2 antigen test can now detect the SARS-CoV-2 virus in asymptomatic individuals as well. The low-cost antigen test can perform 130 tests in one hour, making it a viable testing method for high-throughput testing and monitoring across large communities and populations.

A study conducted by Kaiser Permanente researchers found that a new tool developed by the care consortium helps in accurately predicting patient outcomes individuals infected with Covid-19. The COVAS tool investigates comorbidities, vital signs, obesity, age and sex, and has been fused into the electronic health record system in Southern California to support and guide emergency and critical care centres.

Siemens Healthineers has been awarded a $12m contract by the US Department of Health and Human Services (HHS) and the US Department of Defence (DoD) to support the domestic production of two diagnostic tests for Covid-19. The funding is an addition to the $13m awarded by HHS earlier, to fast-track the company’s development of the diagnostic tests.

Dubai Health Authority (DHA) officials have announced a new saliva test that has been initiated to detect the SAR-CoV-2 virus among children aged between three and 16 years across all DHA-run Covid-19 screening centres in Dubai. The new test was introduced as children found it difficult to take the nasal swab test, thereby encouraging greater screening of kids for the infection, reports the Khaleej Times.

10:10 am

Coronavirus company news summary – PathoFinder obtains CE Mark for two multiplex SARS-CoV-2 MDx tests – Imanis Life Sciences announces improvements and increased capacity

The Apollo Hospitals Group and Tata Medical and Diagnostics (TataMD) have announced the launch of the TataMD CHECK diagnostic test, reports the Times of India. The test is designed to get quicker test results for Covid-19 in India. It is based on the DNA genome editing tool CRISPR Cas-9, which helps in the quicker delivery of results due to its agile AI-based automated detection procedure.

Cue Health has announced that the US Department of Health and Human Services (HHS) will start deploying its molecular, point-of-care Covid-19 tests across five states: Alaska, Louisiana, Florida, New Jersey and Texas. The tests will be utilised to detect positive and negative cases at nursing homes, assisted living facilities, long-term care, veterans’ homes, and will also be deployed at the Department of Defence.

PathoFinder, a Dutch molecular diagnostics developer, has obtained CE IVD marking for two of its multiplex PCR tests for fighting the SARS-CoV-2 virus and other respiratory pathogens. The firm specifically obtained the CE certification for the RespiFinder 2Smart kit for SARS-CoV-2 and MERS-CoV testing, as well as for the RAQ Flu/Covid-19 PCR kit.

Imanis Life Sciences, a laboratory assays and research services provider, announced that it had completed the validation of its improved IMMUNO-COV assay, in detecting and quantifying SARS-CoV-2 neutralising antibodies. The validation adds plasma as a sample type and improves sensitivity and stability along with high accuracy.

9:15 am

Coronavirus company news summary – Cipla launches Covi-G for Covid-19 rapid antibody detection – JOYSBIO releases rapid Covid-19 antigen test

Cipla has entered into a licensing agreement with Multi G for the distribution of Multi G’s Covi-G rapid antibody test kit across Europe and most emerging markets. Covi-G was among the earliest antibody kits to declare CE compliance and has been commercialised in over countries already. With sensitivity and specificity exceeding 92%, it tests for both IgM and IgG antibodies using a single-prick blood test. It gives results within 10 minutes.

SummerBio, a diagnostic company, has partnered with the University of California Los Angeles (UCLA) and the Los Angeles Unified School District (Los Angeles Unified) to launch high-volume testing for the Covid-19 virus. The SummerBio SARS-CoV-2 Test is a nasal swab test conducted by health professionals and produce results within 24 hours.

JOYSBIO Biotechnology has introduced a new rapid Covid-19 antigen test kitwith a nasal swab that can be inserted approximately 2.5 cm into the nostril. This is less invasive than a conventional nasopharyngeal swab, but simple to use like a saliva test. The SARS-COV-2 Antigen Rapid Test Kit is produces results in 15 minutes and is available at all medical stores for home testing and as per local legislation.

Eurofins Viracor, an infectious disease testing laboratory, has announced the launch of combined SARS-CoV-2 Plus Flu A/B and RSV tests. The tests helps in the early detection of multiple pathogens to enable further treatment decisions.

9:28 am

Coronavirus company news summary – FDA authorises first Covid-19 test for self-testing at home – PharmaJet and Diomics partner on immune response monitoring

The US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) for the first Covid-19 diagnostic test to conduct self-testing at home. The Lucira COVID-19 All-In-One Test Kit is a molecular single use test offers rapid results in the detection of the SARS-CoV-2 virus.

Iran’s first vice president Es’haq Jahangiri has hosted the launch of the country’s first rapid Covid-19 antibody test, reports the Tehran Times. Iran is the fifth country to have developed rapid testing technology, following the US, UK, South Korea and China. The test, which can detect the SARS-CoV-2 virus in just 15 to 20 minutes, has been used on approximately 500 patients under the supervision of the Pasteur Institute of Iran.

Trinity Biotech, a developer of diagnostic test kits, has started selling its Covid-19 antibody test in the US, reports the Irish Times. The company is expecting to obtain the CE Mark that allows the product to be sold in the European Union (EU) shortly. The company’s IgG ELISA antibody test still awaits FDA approval, while having sought approval for emergency use authorisation in the country.

PharmaJet has announced that its Tropis Needle-free Injection System will be used by Diomics, a San Diego-based biotech company, to deliver a biopolymer to detect the formation of an immune response to a SARS-CoV-2 protein. The Department of Defense has also awarded the company over $2m to fast-track testing and clinical trials with its Diocheck system, to begin in December 2020.

9:22 am

Coronavirus company news summary – Dana-Farber and Quest Diagnostics collab to identify risk of multiple myeloma after Covid recovery – Balanced Biotech and CSU sign licensing agreement for electronic point-of-care antigen test

Tempus and the Yale School of Public Health have collaborated to fast-track the development of Covid-19 diagnostic tests in the US. The research partnership will leverage the SalivaDirect diagnostic test developed by the Yale researchers to will establish its suitability for at-home sample collection and combined Covid-19 and infleunza testing.

Cape Biologix Technologies, a subsidiary of Cape Bio Pharms, Inno-3B and PlantForm Corporation have entered into a commercial agreement to increase the production of plant-based SARS-COV-2 antigens for Covid-19 antibody blood test. The move is made to scale the production of low-cost, plant-based proteins for Covid-19 monitoring and surveillance.

Dana-Farber Cancer Institute, a cancer research and treatment centre, and Quest Diagnostics have launched a new study which will provide Covid-19 antibody testing for free to people with a high risk of developing multiple myeloma after recovering from the disease. The Immune Profiling with Antibody-based Covid-19 Testing (IMPACT) study will investigate the impact of Covid-19 on people at a higher risk of developing myeloma, or who have a precursor condition to myeloma.

Balanced Biotech and the Colorado State University Research Foundation have entered into a licensing agreement for the Rapid On-the-Spot COVID Test developed by CSU professors and students. The test, initially designed for self-use nasal swab sample collection, uses a sensing method similar to what is used in handheld glucometers to detect active Covid-19 infection.

9:10 am

Coronavirus company news summary – Saliva-based antibody test highly accurate in initial study – First SARS-CoV-2 antigen test to be available in Mexico

Chembio Diagnostics has received Agência Nacional de Vigilância Sanitária (ANVISA) regulatory approval to commercialise its DPP SARS-CoV-2 antigen test in Brazil. The test is designed to detect SARS-CoV-2 antigens in just 20 minutes.

The Johns Hopkins Bloomberg School of Public Health has developed a new saliva-based test that can accurately detect antibodies against the SARS-CoV-2 virus. The test is conducted with the help of small saliva samples instead of finger prick blood withdrawals, the results of which can be obtained in hours.

Kabla Diagnosticos has announced the launch of a rapid diagnostic test to detect the SARS-CoV-2 virus antigen in Mexico. The Sofia SARS Ag test was the first to obtain US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) in the US and is also the first test to be validated by Mexico’s Institute of Epidemiological Diagnosis and Reference (INDRE).

Relay Medical and Fio, together known as the Fio Rapid Response Group (FRR), have netted over $500,000 CAD in initial contracts for the Fionet mobile testing and tracking platform. The platform enables widespread testing against infectious diseases, including Covid-19. FRR has collaborated with South Korea’s IVD Lab Co, with funding received from the National Research Council Canada (NRC), to market the new rapid diagnostic test platform. It is currently being validated at Toronto’s University Health Network (UHN).

9:46 am

Coronavirus company news summary – LogicInk and Contakt World partner to accelerate development of Covid-19 Biosensor Sticker – DnaNudge launches lab-standard 90-minute Covid-19 Bubble Test

AnPac Bio-Medical Science has completed US Food and Drug Administration (FDA) approved antibody test verification in its California lab this month. The Roche Elecsys Anti Sars-COV-2 test will now enter the commercial stage testing, with the Covid-19 antibody test equipment also installed in its Philadelphia lab.

LumiraDx, a diagnostic company, has announced a $32m global partnership with Africa Union, Africa Medical Supplies Platform (AMSP), Africa Centres for Disease Control and Prevention, Bill and Melinda Gates Foundation, and Clinton Health Access Initiative along with the Mastercard and the Rockefeller Foundations to expand and accelerate testing in Africa. LumiraDx will provide 5,000 portable diagnostic instruments and related Covid-19 antigen tests, while AMSP will supply it equitably across 55 African Union member states

LogicInk and Contakt World Technologies Corp announced a collaboration and signed a Memorandum of Understanding (MOU) to fast-track the development of LogicInk’s non-invasive, biosensor sticker for Covid-19. LogicInk’s new signal will enable self-administration and interpret results for the SARS-CoV-2 infection by simply identifying a colour combination.

DnaNudge, which created the rapid, lab-free CovidNudge test used by the NHS, announced the launch of the 90-minute Covid-19 Bubble Test, offering group testing on one cartridge for bubbles up to 10 people with no coronavirus symptoms. The breakthrough test is now available for online booking and through appointment only from DnaNudge’s London’s Covent Garden. It will also be made available as an at-home, by-post service within weeks in the UK.

9:53 am

Coronavirus company news summary – TataMD launches test for Covid-19 – University of Queensland develops Covid-19 viral proteins

Tata Medical and Diagnostics has launched a new Covid-19 diagnostic test, reports LiveMint. The TataMD CHECK was developed through a collaboration between the Indian Council of Scientific and Industrial Research and the Institute of Genomics and Integrative Biology. The test can provide results within 90 minutes, with Tata’s plant in Chennai reportedly able to produce 1 million test kits a month.

Locally produced proteins in Brisbane are proving to be useful for detecting Covid-19. The University of Queensland’s Protein Expression Facility (PEF) has collaborated with the Public Health Virology team at Forensic and Scientific Services (FSS), to develop SARS-CoV-2 viral proteins. The proteins will be utilised in blood tests to screen antibodies for any prior exposure to Covid-19.

Clinical Reference Laboratory (CRL) has begun selling its CRL Rapid Response™ self-collected saliva test directly to consumers. The at-home saliva test is designed to be easy to use, and can delivers results onto users’ mobile phones through an authentication portal within 24 hours.

Centogene and Fujirebio Europe have collaborated to use LUMIPULSE® G technology for large-scale distribution of Covid-19 antigen testing. The tests will be further deployed at German airports, with Centogene having set up test centres at four of Germany’s largest airports in the last six months. Fujirebio is expected to supply Lumipulse G SARS-CoV-2 Ag assays on automated CLEIA-based LUMIPULSE G1200 instruments.

10:19 am

Coronavirus company news summary – Fluidigm and Healthvana partner to offer faster test results delivery – Quansys Biosciences receives FDA EUA for antibody test

Eurofins Technologies has launched the GSD NovaPrime® SARS-CoV-2 Mplex FLA kit for Sanger sequencing instruments. Many of these instruments have been installed worldwide, meaning this launch could help boost throughput testing capacities. More than 2,000 samples can be processed in a day with the help of this assay, with the test kit providing sensitivity and time to results similar to qRT-PCR testing.

The US Food and Drug Administration (FDA) has authorised the first antibody test for point-of-care settings in the US. The Assure Tech Fastep® COVID-19 IgG/IgM Rapid Test Device will be distributed by Carolina Liquid Chemistries, and will be conducted with fingerstick whole blood samples only at certified point-of-care settings.

Fluidigm Corporation has announced a partnership with Healthvana to provide clinical laboratory customers utilizing the Fluidigm® saliva-based Advanta™ Dx SARS-CoV-2 RT-PCR Assay with the option to deliver test results faster via Healthvana’s mobile platform. Ramin Bastani, the CEO of Healthvana stated that on an average, patients were able to view their results within 30 minutes.

Quansys Biosciences has received FDA EUA for its IgG antibody test. A positive IgG antibody result helps detect patients who have been exposed or infected with the SARS-CoV-2 virus, and show adaptive immune response when patients are recovering from the infection.

3:32 pm

All UK contact-tracing apps now interoperable

Scotland’s federated server, which allows for all Covid-19 contact-tracing apps in the UK, Crown Dependencies and Gibraltar to work with each other, has now enabled interoperability with England and Wales’ NHS COVID-19 app and Gibraltar’s Beat COVID Gibraltar app.

Interoperability was achieved between the apps in Scotland, Northern Ireland and Jersey on 28 October.

App users do not need to do anything for this software to work other than keep their app active when travelling between territories. Citizens are still being urged to do so only for essential reasons.

10:15 am

Coronavirus company news summary – Health Canada approves Precision Biomonitoring’s rapid SARS-CoV-2 testing device – South Korea approves single test for Covid-19 and flu

Ortho Clinical Diagnostics has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its new VITROS® SARS-CoV-2 antigen test to help detect the SARS-CoV-2 virus. The company also received CE mark certification, allowing the company to market the test across European Union (EU).

Stanford University engineers have created an automated device, which can help detect Covid-19 by leveraging “lab on a chip” technology. Performed on a device about half the size of a credit card, the test is yields results in only thirty minutes. It is cheap, and not reliant on antibodies like other tests, stated researchers.

Health Canada has approved Precision Biomonitoring’s thermostable TRIPLELOCK™ test strips for use across the country. The TRIPLELOCK™ test strips are used as part of rapid diagnostic RT-PCR testing, and can provide results for nine samples in one hour. The cost-effective Canadian-made test will target the second wave of Covid-19 infections in Canada. Precision Biomonitoring has also received funding from the Next Generation Manufacturing Canada (NGen) for further thermostable test manufacturing.

South Korea health officials have approved a new test that can detect Covid-19 and seasonal influenza in the same sample, reports AP. This is intended to curb the spread of the disease in hospitals as the pandemic stretches into the winter season. Experts believe the likelihood of a virus flare in the cold weather when people will stay indoors. The Korea Disease Control and Prevention Agency recently reported 118 new Covid-19 cases, mostly from Seoul.

9:55 am

Coronavirus company news summary – Truvian’s antibody tested validated in study – Novarad launches free Covid-19 AI diagnostic tool

A University of Chicago research study has validated the performance and accuracy of Truvian Sciences’ easy check Covid-19 IgM/IgG™ antibody test. The clinical study carried out by the researchers found high overall accuracy rates for SARS-CoV-2 virus antibody detection.

OraSure Technologies, a point-of-care diagnostic tests provider, announced that its subsidiary DNA Genotek has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its ORAcollect®·RNA saliva collection device for collecting, stabilising and transporting saliva samples containing SARS-CoV-2 RNA.

Novarad, a transformative imaging technologies company, has launched a new Covid-19 artificial intelligence (AI) diagnostic tool to advance Covid-19 diagnosis worldwide at no cost. The diagnostic assistant was developed in collaboration with Intel Corp., leveraging Microsoft Azure’s cloud computing service to detect Covid-19 from CT scans. It is able to deliver results in seconds, coupled with information on lung conditions.

Assay Genie, a Dublin-based company, stated that it is close to launching a rapid Covid-19 antigen test that will be available in pharmacies. The company intends to sell the antigen tests at a cost of between $17 and $29, which is seven times cheaper than other tests available in the market. The test delivers results in 15 minutes with an accuracy rate between 92% and 98%.

9:30 am

Coronavirus company news summary – Netherlands orders BD antigen tests – Alveo receives grant to develop Covid-19 testing platform

The Dutch Ministry of Health has placed an order with BD (Becton, Dickinson and Company), a global medical technology company, to supply nine million of its rapid antigen tests for the BD Veritor Plus System that helps in detecting the SARS-CoV-2 infection in symptomatic individuals within 15 minutes. Approximately 1.2 million tests are expected to be delivered by mid-November.

The Institute of Inflammation, Immunology and Infectious Disease at Purdue University has collaborated with IdentifySensors Biologics, a technology firm, to develop a rapid diagnostic platform for detecting the SARS-CoV-2 virus and other pathogens. The platform will also detect infections such as influenza, dengue, Zika, HIV/AIDS, Lyme disease, hepatitis C, mumps, chickenpox, measles, foodborne pathogens, and methicillin-resistant staphylococcus Aureus (MRSA).

Hygea Precision Medicine, a precision medicine software company, announced that it has collaborated with testing-as-a-service (TaaS) provider to deliver Covid-19 saliva tests across the country, which are designed to be easy and convenient to administer remotely.

Alveo Technologies announced that it has been awarded a grant from the Bill & Melinda Gates Foundation to test the use and performance of its Covid-19 testing platform, be.well. If successful, the company will look to further its development and manufacturing of the platform, which the company says is as accurate as a PCR test while providing rapid test results via smartphones.

3:11 pm

NHS COVID-19 app failed to record potential exposures

England and Wales’ NHS COVID-19 contact tracing app has failed to alert users of potential exposures due to a programming error.

The wrong threshold for exposure was reportedly set on the app. When it should have recognised people as having been in close enough proximity to transmit the virus, it instead recorded that they were too far apart.

This means that many of the ‘phantom notifications’ being sent by the app, which Zühlke UK CEO Wolfgang Emmerich, whose team helped develop NHS COVID-19, recently told Medical Device Network indicated a ‘near-miss’, may have been genuine contacts.

9:28 am

Coronavirus company news summary – Hologic awarded US government contract to expand Covid-19 tests – Prenetics acquires Oxsed to scale rapid Covid-19 testing globally

Hologic has been awarded a $119 million US govrnmen contract for the expansion of its production capacity for Covid-19 molecular tests. The contract will support investments that will enable Hologic to deliver 13 million Covid-19 tests each month in the US by January 2022.

DNAFit, a subsidiary of Hong Kong-based Prenetics Limited, has acquired Oxsed, an Oxford University spinout which has developed the RaVID Direct Covid-19 test kit. Th kit has a 92% to 100% sensitivity, providing a scalable and low-cost option for Covid-19 testing that can be carried out anywhere and provide results within 15-30 minutes. DNAFit and Prenetics now have exclusive global rights to Oxsed technologies.

Credo Diagnostics has received a CE mark for its VitaPCR™ Influenza A&B/SARS-CoV-2 assay, a rapid molecular test that helps in detecting Covid-19, flu A and flu B infections from a single sample. The three-in-one test across Credo Diagnostics VitaPCR™ systems worldwide and delivers results within 20 minutes.

Celltrion USA, a subsidiary of Korean medtech firm Celltrion, has signed a contract to supply $22m worth of Covid-19 diagnostic tests to the US. The contract was signed following the issuing of Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for Celltrion’s SAMPINUT rapid antigen test kit. The kits will be distributed with exclusive rights in New York.

10:11 am

Coronavirus company news summary – Cipla launches ELIFast Covid-19 antibody test in India – EKF and Kantaro partner to market Covid-19 antibody testing in Europe

Cipla has announced the launch of its ELIFast Covid-19 antibody detection kits in India. The pharmaceutical company has partnered with KARWA to market and distribute the  test. The Indian Council of Medical Research (ICMR) has provided the technological know-how and process for development of the test kits.

Kantaro Biosciences and Bio-Techne have entered into a two-year agreement with EKF Diagnostics, a diagnostic testing company, to market and distribute Kantaro’s Covid-SeroKlir antibody test kit in Europe and Covid-SeroIndex for European research. Both the products have received CE Mark certification for detecting the amount of IgG antibodies in infected patients.

Victory Square Health (VSH), a portfolio company of Victory Square Technologies, announced that it has entered into a sales and distribution agreement to provide its 15-minute rapid testing kits and Safetest Covid-19 Elisa to Bulgaria, Cyprus, Greece, Romania, Serbia, and Northern Macedonia. The kits will also be made available to some regions in the Middle East.

GoGetTested has announced the availability of FDA-approved PCR Covid-19 testing in Columbia, South Carolina. GoGetTested will also open a Covid Response Operating System and mobile testing sites across the city, facilitating free tests for all South Carolina residents whether insured or not.

9:43 am

Coronavirus company news summary – Study identifies biomarkers for Covid-19 blood screening tool – Jiaotong University develops rapid Covid-19 testing system

Researchers from the Lawson Health Research Institute, Western University and University of Alberta study suggested that Covid-19 affects the concentration levels of specific metabolites in human blood. The team of researchers have identified three biomarkers that can be used an inexpensive and quick blood test to detect the presence of the virus in patients and predict patients likely to become critically ill.

Sixth Wave Innovations has received $250,000 from the Nova Scotia Covid-19 Response Council (NSCRC) to develop its Accelerated Molecularly Imprinted Polymer (AMIPs™) technology for rapid Covid-19 testing. The company aims to incorporate the technology into many rapid virus test kits, and in air and water monitoring schemes.

A Jiaotong University team has released a rapid screening test solution to detect the SARS-CoV-2 virus. The five-minute test helps identify antibodies against new coronary pneumonia. The test analyses the degree of the infection, a recent or prior infection, with the presence of the antibodies that can help in further diagnosis and treatment of the patient.

ICT International announced that it is making rapid antigen testing available to the UK and European markets. The test does not require expensive equipment or laboratories.

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Coronavirus company news summary – PerkinElmer receives CE Mark for RT-PCR panel – Rosti to manufacture 15-minute Covid-19 test

PerkinElmer, a diagnostics and imaging company, has received CE Mark approval in the EU for its PKamp™ Respiratory SARS-CoV-2 RT-PCR panel. The panel allows for the detection of SARS-CoV-2 and other influenza viruses in a single test. It is currently under review by the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA).

Ginkgo Bioworks has secured supply to the SD Biosensor rapid antigen test. The company will distribute the test through its Concentric Covid-19 testing service in international markets where the test is approved. Ginkgo aims to acquire and distribute up to 50 million tests.

Rosti Group, a contract manufacturer, has formed a collaboration with Global Molecular Diagnostics to produce a Covid-19 saliva test capable of delivering accurate results within 15 minutes. The test will enable fast and on-site detection of SARS-CoV-2 virus even by non-medical personnel.

Ortho Clinical Diagnostics has received CE Mark approval for its VITROS® SARS-CoV-2 antigen tes. The test is suitable for mass testing and deliver results with a specificity of 99.2%. Ortho has also submitted an EUA application for the test with the FDA.

Helix, a genomics company, has received expanded EUA from the FDA for its HelixⓇ Covid-19 test, which is indicated for testing asymptomatic individuals. The expanded approval enables individuals to self-collect samples without the need for supervision by healthcare professionals.