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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.

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.

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

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

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

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

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

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.

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

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.

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