Thermo Fisher Scientific (NYSE:TMO) announced today that it received FDA emergency use authorization (EUA) for a COVID-19/flu combo test.
Carlsbad, Calif.-based Thermo Fisher’s Applied Biosystems TaqPath COVID-19, Flu A, Flu B combo kit is a real-time PCR test for detecting and differentiating RNA from SARS-CoV-2, influenza A and influenza B viruses in nasopharyngeal and nasal swabs, according to a news release.
The company’s kit includes Applied Biosystems pathogen-interpretive software for converting genetic analysis data into a readable report automatically to reduce the risk of errors with interpretation, Thermo Fisher said.
Testing with the TaqPath COVID-19, Flu A, Flu B combo kit is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high-complexity tests, or by similarly qualified non-U.S. laboratories.
“Understanding that the flu season would overlap with surges in COVID-19 infections, Thermo Fisher worked rapidly to develop a new multiplex real-time PCR diagnostic kit for detecting and differentiating SARS-CoV-2, influenza A and influenza B. These are illnesses which can present with similar clinical symptoms, but for which patient management, including quarantining measures, greatly differs,” Thermo Fisher president of genetic sciences Mark Smedley said in the release. “This new kit offers clinical and public health laboratories a single test to help diagnose and monitor the spread of COVID-19 and the flu.”
