The US FDA has issued an emergency use authorization (EUA) to Thermo Fisher Scientific (MA, USA) for a COVID-19 diagnostic test. The EUA grants USA-based CLIA high complexity laboratories immediate permission to use the diagnostic test for COVID-19.
Under the EUA, the diagnostic test can be used to detect nucleic acid from SARS-CoV-2, the virus responsible for causing COVID-19, but not any other viruses or pathogens.
The test, from global life science company Thermo Fisher Scientific, makes use of the Applied Biosystems TaqPath Assay technology. This technology is designed to facilitate rapid testing, with time-to-result (including sample preparation and analysis) estimated to be around 4 hours of the lab receiving the sample.The COVID-19 diagnostic test is currently optimized for use on Thermo Fisher Scientific’s Applied Biosystems 7500 Fast Dx real-time PCR instrument, which has also been covered by the EUA.
The diagnostic test is not FDA cleared or approved. However, in light of the public health emergency – declared by Alex Azar (Secretary, US Department of Health and Human services; DC, USA) for COVID-19 on January 31 2020 – the US FDA can issue an EUA to permit the use of specific medical products that could be effective in diagnosing, treating or preventing a disease or condition.
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Under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), the COVID-19 diagnostic test is only authorized under the EUA for the duration that circumstances exist which justify the emergency use of in vitro diagnostic tests for the detection and/or diagnosis of COVID-19.
Mark Casper (Chairman, President and CEO, Thermo Fisher Scientific explained: “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.”
Update: 26 March 2020
Thermo Fisher Scientific COVID-19 diagnostic test receives CE mark
Thermo Fisher Scientific’s COVID-19 diagnostic test which uses Thermo’s Applied Biosystems TaqPath assay and real-time PCR technology has received the CE mark in the European Union. Tests will now be made available for qualified labs.
The CE mark certifies that the COVID-19 diagnostic test conforms with the relevant EU directives regarding health and safety and environmental protection. Marc Casper explained: “The CE mark certification is an important step in combatting the outbreak of COVID-19 across Europe. We are committed to fighting this disease and we will continue to work with regulatory authorities and customers around the world to expand the availability of diagnostic testing and stem the spread of the coronavirus.”