FDA quickly OKs its 2nd commercial COVID-19 test, from Thermo Fisher

Shortly after the FDA granted an Emergency Use Authorization to its first commercially developed coronavirus test—developed by Roche for use on its high-throughput cobas system—the agency did the same for Thermo Fisher Scientific’s diagnostic.

The green lights for both tests were granted within 24 hours of receiving their applications, the FDA said. This now allows for the immediate use of Thermo Fisher’s TaqPath COVID-19 Combo Kit on its Applied Biosystems 7500 Fast Dx real-time PCR hardware in certain high-complexity laboratories nationwide.

Thermo Fisher said the test, designed to detect the specific nucleic acids from the virus SARS-CoV-2, can provide results within four hours, including the time needed to prepare the sample and perform the analysis.