Thermo Fisher Scientific (TFS) unveiled that the Food and Drug Administration (FDA) has issued the company’s diagnostic test, which can be used immediately by US CLIA high-complexity laboratories to detect nucleic acid from the virus that causes COVID-19, emergency use authorisation (EUA).
The test, which has been designed to provide results within four hours of a sample being received by a lab, uses Applied Biosystems TaqPath Assay Technology. TFS currently has one-point-five million tests available under the EUA mark and plans to increase this speedily to two million tests per week. When the company has the resources at its disposal in April, it will dramatically increase the rate of production during that month, to five million tests per week.
“Thermo Fisher Scientific's diagnostic test has been issued EUA.“
The test has been developed to work on the company’s Applied Biosystems 7500 Fast Dx Real-time PCR instrument, which has already received EUA and used in laboratories globally.
President, CEO and Chairman of TFS, Marc N. Casper, stated: "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. 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."