FDA warns providers about problems with Thermo Fisher’s COVID-19 test

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Shares of Thermo Fisher Scientific Inc. were down 0.1% in premarket trading on Tuesday, the day after the Food and Drug Administration sent an alert warning health care providers about a risk of false-positive results when using the TaqPath COVID-19 test. The regulator cited problems with some of the test’s equipment and its software, both of which can be addressed. The test received an emergency use authorization on March 13, making it one of the first diagnostic tests to receive a regulatory okay during the COVID-19 pandemic. Thermo CEO Marc Casper told investors during an earnings call in July that its coronavirus “PCR-based workflow is widely used in 50 countries and these tests are considered the gold standard given their high level of accuracy,” according to a FactSet transcript. Thermo’s stock has rallied 28.3% so far this year, while the S&P 500 has gained 4.7%.
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