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July 07, 2020

Health Law Daily

FDA Issues Emergency Authorization For Combined COVID-19, Influenza Test

  • July 07, 2020

FierceBiotech (7/6, Hale) reports, “The FDA issued a new emergency authorization to the Centers for Disease Control and Prevention for a combination influenza and COVID-19 diagnostic test,” which “is designed to help tell the difference between patients with one of the two diseases, who may present with similar respiratory symptoms.” The test – which runs on “Thermo Fisher’s Applied Biosystems 7500 sequencing hardware” – is “the third diagnostic authorized by the FDA for this purpose, following panels from Qiagen and BioFire Diagnostics, which also cover additional viruses.”