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Startups spar with FDA over what constitutes a home coronavirus test



Federal regulators and health tech startups are increasingly at odds over the permissibility of at-home testing for Covid-19, the disease caused by the novel coronavirus.

Two companies told STAT this week that their tests were cleared for patients to take at home — including one that said it has already processed thousands of tests. The companies insist they are permitted to sell the tests because they are ordered by physicians and processed in certified labs. The FDA, however, remains adamant that isn’t the case.

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