First at-home combination test for COVID and flu authorized by FDA

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First at-home combination test for COVID and flu authorized by FDA
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The FDA has authorized the first over-the-counter at-home test that can detect and differentiate between COVID-19 and the flu.

100% of negative and 88.3% of positive COVID-19 samplesWhat is Lucira Health?

A medical technology company based in Emeryville, California, Lucira Health had hoped to receive an emergency use provision from the FDA at about the same time it got authorization from Canada. It had already begun manufacturing tests to meet anticipated demand – as demand for its COVID-19 test declined. Without the expected revenue from the combo test, the company has filed for Chapter 11 bankruptcy protection and plans to pursue a sale of the business,“Unfortunately, as restrictions lessened in 2022, we saw lower demand for COVID-19 tests.

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