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Hologic Upgrades Aptima SARS-Cov-2 Assay Authorization To Full FDA Approval

Molecular Diagnostic Assay Secures FDA 510(k) Clearance

 
• By Natasha Barrow

Hologic attains full US Food and Drug Administration 510(k) clearance for its Aptima SARS-CoV-2 assay, which reached market under an Emergency Use Authorization (EUA). Overall, Hologic’s “best-performing” molecular diagnostic business continues to grow despite the decline in revenue for COVID-19 assays and related items.

COVID-19 test
(Shutterstock)

Hologic’s Aptima SARS-CoV-2 assay upgraded its Emergency Use Authorization (EUA), granted in May 2020, to full a US Food and Drug Administration 510(k) clearance on 18 February.

The FDA issued EUAs for several hundred COVID-19 tests that had not gone through the traditional regulatory process in order to control the spread of the virus during the pandemic

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