MedCity News February 26, 2023
Frank Vinluan

Lucira Health now has the first FDA authorized diagnostic that detects the novel coronavirus and influenza in a single test. But the regulatory decision comes too late for the diagnostics developer, which has filed for bankruptcy protection.

Cough, fever, and breathing difficulty could signal a Covid-19 infection. It could also be the flu. A Lucira Health diagnostic is now the first one authorized by the FDA to identify the culprit virus in a single test, yielding results in about 30 minutes. But the regulatory decision for the diagnostic did not come fast enough for Lucira.

Two days before the FDA’s Friday announcement of Lucira’s new emergency use authorization (EUA), the company disclosed it had filed for bankruptcy protection, a move...

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Topics: FDA, Govt Agencies, Healthcare System, Patient / Consumer, Provider, Public Health / COVID
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