Startups touting at-home coronavirus tests suspend plans after FDA warning

In a rapid about-face, a handful of startups that had already rolled out at-home coronavirus test kits or planned to start selling them soon have suspended their efforts. It’s the latest twist in an ongoing situation that has unfolded as tech companies have rushed to fill testing gaps with direct-to-consumer kits — and as regulators have rushed to wrangle them.

Late last week, several startups told STAT they would begin selling at-home coronavirus tests, mailing kits to customers who would then swab their own mouths or throats and place the samples in the mail. Commercial labs would test the samples, and customers would receive results in a few days. Experts warned that the new tests may not meet the Food and Drug Administration’s high standards for traditional approval, however, and cautioned that consumers might not get an accurate result if they didn’t swab deep enough in their nose or throat.

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