March 16, 2020—Thermo Fisher Scientific announced that on March 13, the FDA issued an emergency use authorization for Thermo Fisher’s 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 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 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,” Marc N. Casper, chairman, president, and chief executive officer of Thermo Fisher Scientific, said in a press release. “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.”
Thermo Fisher has 1.5 million tests available to ship under the EUA label and expects to quickly increase to 2 million tests per week. Based on availability of raw materials and an installed instrument base, the company expects to scale up production to 5 million tests per week in April. Tests will initially be distributed to about 200 labs in the U.S. and Thermo Fisher will continue to work in partnership with government agencies and private partners to expand access.
The EUA test is optimized for use on the company’s Applied Biosystems 7500 Fast Dx Real-time PCR instrument.