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NEW YORK – The US Food and Drug Administration on Friday granted BioFire Diagnostics' Respiratory Panel 2.1 Emergency Use Authorization.

The panel, which uses PCR and takes about 45 minutes to run, is designed to detect and differentiate between nucleic acids from SARS-CoV-2 and 20 other viral and bacterial respiratory pathogens — including various influenza A subtypes, respiratory syncytial virus, and Bordetella pertussis — in nasopharyngeal swabs from individuals suspected of having COVID-19.

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The US Food and Drug Administration is to announce stricter standards for emergency authorizations of SARS-CoV-2 vaccines, reports the Washington Post.

The Associated Press reports Johnson & Johnson is starting a late-stage clinical trial of its candidate SARS-CoV-2 vaccine.

Bloomberg reports the budget of Operation Warp Speed is actually $18 billion, higher than the number typically cited.

In Genome Research this week: genomic analysis reveals role of super-spreaders in SARS-CoV-2, epigenetic drivers of cancer, and more.

Oct
09
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As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.