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BioFire COVID-19 Test De Novo Clearance Paves Way For Other EUAs To Stay On The Market

 
• By Elizabeth Orr

BioFire’s test detects a range of respiratory and bacterial infections, including SARS-CoV-2. Its clearance is the first example of how other products with EUAs can stay on the market after the pandemic.

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• Source: Shutterstock

More than 300 COVID-19 diagnostics have come to market via the US Food and Drug Administration’s emergency use authorization (EUA) process since the pandemic began last year. But on 17 March, bioMerieux Inc subsidiary BioFire Diagnostics Inc. became the first developer to see a test for the novel coronavirus gain FDA clearance through a traditional pathway.

The agency announced that it has granted de novo clearance to the BioFire Respiratory Panel 2.1 (RP2.1), which opens the door for 510(k) clearance for similar tests. The diagnostic, which...

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