Mastodawn

The first-ever at-home combination #flu + #Covid test got an EUA on Friday, but the test's maker, Lucira, went #bankrupt Wednesday.

Test manufacturers that got their big break with Covid $ are trying to pivot to Covid+flu tests, but snail's-pace #FDA authorization means these companies missed this flu season and are now going under.

What is the FDA trying to do here?

Some weekend news @STAT:
https://www.statnews.com/2023/02/26/fda-flu-covid-home-test-lucira/

The FDA has cleared the first home flu and Covid test — but its maker just declared bankruptcy

The FDA's authorization of the first at-home test that can detect flu and Covid-19 came just days after the test's maker, Lucira, filed for bankruptcy.

STAT

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Brittany Trang Feb 27, 2023

For more context, I first asked why the US doesn't have at-home #flu tests back in November.

Multiple test manufacturers told me they were frustrated with the difficulty of actually getting at-home tests approved, despite the #FDA's positive public stance on them:

https://www.statnews.com/2022/11/22/why-doesnt-the-u-s-have-at-home-flu-tests/

Why doesn't the U.S. have at-home flu tests?

“It's really rare, and it's really new, that people are allowed to know about what's happening inside their body without a physician in the middle,” says Michael Mina, a former assistant professor of epidemiology at Harvard.

STAT

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Susan Egbert, PharmD Feb 27, 2023

@brittanytrang @STAT

All of this has been super weird lately

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Brian DeViteri Feb 28, 2023

@brittanytrang @STAT Was short sighted for FDA to not allow at home flu tests last fall. Wondering what motivation companies have to continue to develop and innovate for at-home accessible testing for any product if FDA will do the same.