Thermo Fisher Scientific has been granted an emergency use authorization (EUA) for its coronavirus diagnostic test from the US Food and Drug Administration (FDA).
The FDA authorization allows Thermo Fisher Scientific’s COVID-19 diagnostic test that can be immediately used by CLIA high-complexity laboratories in the US for the detection of nucleic acid from SARS-CoV-2, the virus behind coronavirus, and not for any other viruses or pathogens.
According to Thermo Fisher Scientific, the authorized test for coronavirus uses Applied Biosystems TaqPath Assay technology and is designed to deliver patient results inside four hours of the lab receiving a sample.
The life sciences company said that the estimated time-to-result also covers time for sample preparation and also instrument analysis.
Commenting on the FDA authorization of the coronavirus diagnostic test, Marc N. Casper – chairman, president and CEO of Thermo Fisher Scientific, said: “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.”
The COVID-19 diagnostic test is said to be optimized for use on the Applied Biosystems 7500 Fast Dx Real-time PCR instrument of Thermo Fisher Scientific, which is covered under the emergency use authorization and already being used in clinical laboratories across the world.
Thermo Fisher Scientific said that the novel coronavirus diagnostic test has not been cleared or approved by the FDA. However, the regulator can issue a EUA to allow the use of certain medical products that can be effective in diagnosis, treatment or prevention of a disease or condition, as in the case of the novel coronavirus, which has led to the declaration of a national emergency by President Donald Trump.