FDA Issues Emergency Use Authorization to Thermo Fisher Scientific for Diagnostic Test Used to Detect COVID-19

WALTHAM, Mass., March 13, 2020 /PRNewswire/ -Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced today that the U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for its diagnostic test that can be used immediately by CLIA high-complexity laboratories in the U.S. to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19, and not for any other viruses or pathogens.

The authorized test uses Applied Biosystems TaqPath Assay technology and is designed to provide patient results within four hours of a sample being received by a lab. The estimated time-to-result also includes time for sample preparation and instrument analysis.

"The authorization of our diagnostic test for COVID-19 will help to protect patients and enable medical staff to respond swiftly to treat those who are ill and prevent the spread of infection," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "At Thermo Fisher, our Mission is to enable our customers to make the world healthier, cleaner and safer. In partnership with the FDA and regulatory authorities around the world, we are committed to expanding the availability of diagnostic testing to prevent the spread of this disease."

The EUA test is optimized for use on the company's Applied Biosystems 7500 Fast Dx Real-time PCR instrument, which is covered under the EUA and already used in clinical laboratories worldwide.