FDA Issues Emergency Use Authorization to Thermo Fisher Scientific’s Diagnostic Test for COVID-19

March 16, 2020
Pharmaceutical Technology Editors

The test will use Applied Biosystems TaqPath Assay technology and will work to provide patient results within four hours of a sample being received by a lab.

Thermo Fisher Scientific announced on March 13, 2020 that FDA released an emergency use authorization (EUA) for its diagnostic test that can be used by laboratories in the United States to identify nucleic acid from SARS-CoV-2, the virus that causes COVID-19.

According to a Thermo Fisher press release, the test will use Applied Biosystems TaqPath Assay technology and will work to provide patient results within four hours of a sample being received by a lab. Additionally, Thermo Fisher revealed it has 1.5 million tests available to ship under the EUA label and predicts it will scale up to five million tests per week in April to be sent to 200 labs in the US.

"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 CEO of Thermo Fisher Scientific, in the press release. “At Thermo Fisher, our [m]ission is to enable our customers to make the world healthier, cleaner, and safer. In partnership with [FDA] and regulatory authorities around the world, we are committed to expanding the availability of diagnostic testing to prevent the spread of this disease."

Source: Thermo Fisher