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FDA Authorizes First COVID/Flu OTC Test

Lucira's at-home test doesn't require a prescription, provides results in just 30 minutes, and costs $99.

Lucira Covid 19 Flu Home Test Packaging And Device Edit
Lucira

The further into the pandemic we get, the more we treat COVID-19 like the flu. So why don’t we just kill two birds with one stone? According to a recent STAT News article, that’s the plan, for testing at least. The FDA just authorized the use of the Lucira COVID-19 and flu home test kit. The kit includes a nasal swab test that provides results within 30 minutes. The test is authorized for use in people 14 and older and doesn’t require a prescription.

The Lucira test uses molecular amplification technology that detects the presence of viral genetic material in the sample. The FDA notes that the test may not detect all cases of COVID-19 or flu, and that negative results don’t necessarily rule out infection. Nonetheless, the FDA believes that the test's benefits outweigh the risks and that it will be useful in expanding access to testing, particularly for people who can’t get tested in a clinical setting. The Lucira test retails for $99 is the first combination test for COVID-19 and flu to receive FDA authorization for home use.

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Discover the right packaging solutions for life sciences in Philadelphia
Explore innovative packaging and supply chain solutions for the life sciences at the largest PACK EXPO East in history, March 18–20. Get ideas from 400+ top exhibitors and connect with colleagues and industry experts—all in one convenient location!
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Discover the right packaging solutions for life sciences in Philadelphia