Covid-19 live timeline - Verdict Medical Devices
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Covid-19 Coronavirus
  • Global confirmed cases
    178,934,563
  • Global deaths
    3,876,129
  • Global death rate
    2.17%
  • Global recoveries
    129,440,709
  • Global recovery rate
    72.34%
  • Global confirmed cases
    178,934,563
  • Global deaths
    3,876,129
  • Global death rate
    2.17%
  • Global recoveries
    129,440,709
  • Global recovery rate
    72.34%
Covid-19Powered by

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

10:07 am

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

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

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

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

9:42 am

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

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

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

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

9:34 am

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

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

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

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

9:53 am

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

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

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

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

10:21 am

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

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

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

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

10:01 am

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

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

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

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

9:44 am

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

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

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

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

9:35 am

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

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

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

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

10:16 am

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

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

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

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

10:09 am

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

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

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

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

10:25 am

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

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

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

9:11 am

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

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

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

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

10:02 am

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

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

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

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

9:23 am

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

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

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

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

10:16 am

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

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

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

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

9:08 am

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

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

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

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

9:58 am

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

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

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

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

9:37 am

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

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

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

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

9:24 am

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

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

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

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

9:14 am

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

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

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

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

9:10 am

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

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

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

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

9:33 am

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

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

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

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

9:56 am

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

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

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

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

9:23 am

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

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

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

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

9:39 am

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

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

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

10:00 am

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

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

Qiagen has been granted EUA by the US FDA for its digital QIAreach Anti-SARS-CoV-2 Total Test. The authorisation allows the company to provide its portable antibody testing device to all healthcare professionals in the US. One antibody test takes about 10 minutes to identify the presence of antibodies in individuals against the SARS-CoV-2 virus as a result of a prior infection. The test results are read on a digital eHub device capable of processing up to 32 tests every hour.

WhenToTest.org, an online platform that supports Covid-19 mitigation strategies, announced that it has collaborated with the Arizona State University (ASU) and Project N95 to enable organisations to remain open or resume operations, by facilitating the provision of Covid-19 diagnostic tests in small or large numbers from approved suppliers.

10:03 am

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

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

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

Applied DNA Clinical Labs, a subsidiary of biotechnology company Applied DNA Sciences, has received a Clinical Laboratory Improvement Amendments (CLIA) certification from the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) for high throughput diagnostic Covid-19 testing, using methods and devices authorised for emerhttps://www.businesswire.com/news/home/20210511005756/en https://adnas.com/clia-certification-diagnostic-covid-19-testing/https://www.businesswire.com/news/home/20210511005756/en https://adnas.com/clia-certification-diagnostic-covid-19-testing/gency use, including the company’s Linea Covid-19 Assay Kit.

9:57 am

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

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

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

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

9:35 am

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

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

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

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

10:03 am

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

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

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

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

9:46 am

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

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

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

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

9:59 am

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

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

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

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

10:13 am

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

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

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

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

10:18 am

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

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

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

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

9:52 am

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

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

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

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

9:51 am

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

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

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

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

9:54 am

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

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

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

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

9:28 am

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

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

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

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

9:47 am

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

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

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

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

10:12 am

Coronavirus company news summary – Empowered Diagnostics receives CE mark for CovClear Covid-19 rapid antigen test – Sense raises $50m Series B funding to launch Covid-19 molecular test

Empowered Diagnostics has received the CE Mark approval for its CovClear Covid-19 rapid antigen test. CovClear is a lower-cavity nasal swab test that can identify Covid-19 infection within two days of exposure. Quick and easy to use, the test delivers results with 99.7% accuracy, 98.5% sensitivity, and 100% specificity.

QIAGEN has announced the launch of the artus SARS-CoV-2 Prep&Amp UM kit, which uses a liquid sample preparation technology to increase and simplify Covid-19 testing throughput. The test kit is CE-IVD registered, and is therefore allowed to be used in the European Union (EU) and other markets. The company has applied for emergency use authorisation (EUA) by the US Food and Drug Administration (FDA), for its commercialisation and use in the US.

Sense Biodetection has raised a $50m Series B investment to accelerate the commercialisation of its Veros Covid-19 product and a portfolio of instrument-free rapid molecular tests. The Veros platform allows the use of proprietary rapid molecular amplification technology for detecting many deadly and expensive diseases.

10:04 am

Coronavirus company news summary – Abbott begins delivering BinaxNOW Covid-19 Ag self-test to retailers – Therma Bright receives CE approval for Covid-19 rapid antigen saliva test

Abbott has started delivering its BinaxNOW Covid-19 Ag Self-Test to retailers across the US. The test is expected to be available to customers on online platforms and at some retail stores such as CVS Pharmacy, Walmart, and Walgreens without a prescription. The self-test will be more broadly available in the upcoming two weeks. The company manufactures millions of self-tests per month and is looking at scaling capacity based on demand.

Therma Bright has received CE mark approval for its AcuVid Covid-19 rapid antigen saliva test. The company has also secured a conditional purchase order for 100,000 units through McWilliams Collective, a new global distribution partner. The order is secured for a large European client, on conditions that the company provides the initial test data which demonstrates 86%+ specificity and 100% sensitivity, and that the production levels are reached and delivered in June 2021.

RICOVR Healthcare has raised $1.5m to fund the commercialisation of its point-of-care testing device for both tetrahydrocannabinol (THC), a psychoactive constituent of cannabis, and Covid-19 disease. The company’s biosensor platform allows a small saliva sample to deliver results within just five minutes. The funding is expected to support the go-to-market goals for the XALIVA platform.

10:03 am

Coronavirus company news summary – New rapid test kits deployed in Cambodia – Seegene develops the world’s first Covid-19 variant test

The health ministry in Cambodia has started using the Panbio COVID-19 Ag rapid test, which produces results for Covid-19 infection in 15 minutes. Developed by Abbott, the rapid testing has been scaled up in the high-risk provinces and cities such as Phnom Penh, reports the Khmer Times.

Seegene has developed the world’s first Covid-19 diagnostic test capable of screening Covid-19 and identifying multiple mutant variations in a single reaction. The Allplex SARS-CoV-2 Variants I Assay and can detect mutations found in the UK, South Africa, and other countries including Japan and Brazil. The test will also be helpful in scaling up the testing of mutations. According to a company official, Seegene plans to supply its tests to global organizations and governments as its priority.

9:47 am

Coronavirus company news summary – FDA authorises Qorvo Biotechnologies’ rapid Covid-19 antigen test – JOYSBIO Covid-19 neutralising antibody rapid test 98% accurate

Qorvo Biotechnologies has announced that the US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to its Qorvo Omnia SARS-CoV-2 antigen test. The test is now approved to detect viral antigens from SARS-CoV-2 in nasal swabs of suspected individuals.

A clinical study carried out in Italy has found the JOYSBIO Covid-19 neutralising antibody rapid test kit to be 98.05% effective in verifying neutralising antibodies after subjects got vaccinated with the Pfizer-BioNTech vaccine. The inexpensive kit delivers results in 25 to 30 minutes, and could be used to analyse people’s immunity status.

Seegene has announced that its Italian subsidiary, Arrow Diagnostics, has secured the public procurement worth over $99.04m, the largest volume of tender for its Italian branch. As per the agreement, Arrow Diagnostics is expected to supply about 7.15 million Covid-19 diagnostic tests along with extraction reagents to the Italian Ministry of Defence. The Covid-19 diagnostic tests will be distributed across 17 regions including Liguria, Lombardy, Tuscany, and Veneto.

10:28 am

Coronavirus company news summary – Seegene has initiated exporting its latest Covid-19 variant tests – Infinity BiologiX awarded CDC contract to sequence Covid-19 variants

Seegene has received an export licence from the South Korean Ministry of Food and Drug Safety to begin exporting its Covid-19 variant tests across the world. Seegene’s Allplex SARS-CoV-2 Master Assay and the Allplex SARS-CoV-2 Variant I Assay variant diagnostic tests are CE-IVD certified and are shipped to more than 20 countries including Italy, Germany, the Great Britain, France, and Chile.

eMed has announced a new milestone in its State of Colorado partnership that expands free rapid at-home testing to all employees required to interact with the public at their jobs. eMed partnered with the state earlier this year to distribute and administer millions of rapid tests to teachers, staff and students. Coloradan restaurants and food services workers are now eligible for the rapid tests through the Binax at-home programme of the state

Dolphin Neurostim has had its Dolphin Vagal Nerve Stimulator (VNS) approved for emergency use in treating acute Covid-19 respiratory failure in adults by Health Canada. The device enhances the parasympathetic system, reducing lung infection and pro-inflammatory cytokines to improve respiratory functioning.

Infinity BiologiX has been awarded a contract by the Centers for Disease Control and Prevention (CDC) for the genomic surveillance for SARS-CoV-2 variants. The laboratory will provide genomic sequencing and new variant identification of the SARS-CoV-2 virus. IBX launched its Covid-19 saliva-test in May, after receiving an emergency use authorisation from the US Food and Drug Administration (FDA).

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. https://www.globenewswire.com/news-release/2021/02/09/2172248/0/en

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.