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Breaking news on coronavirus testing, with real-time reporting on assays to detect the SARS-CoV2 coronavirus, which causes COVID-19. 

Check out our Coronavirus Test Tracker for the latest information on the regulatory status of these tests in the US, European, and Asian markets.

Dec 05, 2020

FDA Authorizes Quest Diagnostics SARS-CoV-2/Flu Test With Self-Collection Kit for Emergency Use

The EUA from FDA is the first for a diagnostic test for at-home, self-collection of patient samples for detecting the coronavirus and the flu.

Dec 04, 2020

Point-of-Care Roche Liat SARS-CoV-2 Test Shows High Sensitivity in Multisite Trial

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The 20-minute PCR-based test had near complete agreement with lab-based testing.

Dec 04, 2020

FDA Declines to Review EUA for Chembio Diagnostics SARS-CoV-2 Antibody Test

The agency said review of Chembio's EUA request was not a priority because it would have a limited impact on testing capacity.

Dec 04, 2020

FDA Authorizes Use of Pooled Samples With CDC Coronavirus Test

The test originally received Emergency Use Authorization in February for the detection of SARS-CoV-2 nucleic acid in upper and lower respiratory specimens.

Dec 03, 2020

Will US Ever Get to Mass Testing for COVID-19?

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Test capacity, particularly for rapid antigen testing, is set to explode in Q1 2021, but home and asymptomatic assays remain few and far between.

Dec 03, 2020

GeneMe, Biolyph Partner to Ramp Up Capacity of COVID-19 MDx

The GeneMe assay, called FRANKD, is currently being used to test Virgin Atlantic pilots and crew of certain routes departing Heathrow Airport.

Dec 03, 2020

DnaNudge Deploys Direct-to-Consumer Service for PCR-Based Pool Testing of SARS-CoV-2

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Called the COVID Bubble Test, the UK-based service allows the testing of up to 10 people on a single cartridge for £100, or £10 per person.

Dec 03, 2020

FDA Grants Emergency Use Authorization for Innovita Biological Coronavirus Antibody Test

Innovita Biological is also developing a rapid, at-home SARS-CoV-2 serology test that it licensed to Scanwell Health earlier this year.

Dec 02, 2020

Testing of Asymptomatic Patients Moves Into Spotlight During Coronavirus Pandemic

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Some insiders emphasize the importance of doing rapid turnaround testing of asymptomatic people, while others contend lab tests ought to be the modality of choice.

Dec 02, 2020

CDC Advises Avoiding Holiday Travel, Using SARS-CoV-2 Testing to Mitigate Risk During COVID-19 Surge

The agency said people can potentially shorten quarantine time and reduce travel-associated contagion risk with PCR or antigen SARS-CoV-2 testing.

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In Infectious Disease

  1. FDA Declines to Review EUA for Chembio Diagnostics SARS-CoV-2 Antibody Test

  2. Will US Ever Get to Mass Testing for COVID-19?

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  3. Testing of Asymptomatic Patients Moves Into Spotlight During Coronavirus Pandemic

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  4. FDA Authorizes Use of Pooled Samples With CDC Coronavirus Test

  5. FDA Warns Lab Company to Stop Sale of Unauthorized SARS-CoV-2 Collection Kit

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