FDA identifies 3 COVID-19 tests that may be impacted by new variant

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The Food and Drug Administration on Friday said it has identified three authorized COVID-19 tests in the U.S. that may be affected by new SARS-CoV-2 mutations, including the B.1.1.7 variant first pinpointed in the United Kingdom. These tests are Applied DNA Sciences Inc. Linea COVID-19 Assay Kit, the privately held Mesa BioTech Inc.’s Accula, and Thermo Fisher Scientic Inc.’s TaqPath COVID-19 Combo Kit. The regulator said false-negative results may occur in some instances of viral mutations but it expects the impact of the mutations on COVID-19 testing accuracy is “low.” “Importantly, the detection pattern that appears with the TaqPath and Linea diagnostic tests when certain genetic variants are present may help with early identification of new variants in patients to reduce further spread of infection,” the FDA said. The FDA is also evaluating all molecular COVID-19 tests that received emergency use authorization. Shares of Thermo Fisher were up 1.7% in trading on Friday, while Applied DNA Sciences’ stock gained 2.8%. The S&P 500 is up 0.2%.
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