The Waltham, Mass.-based company’s test uses Applied Biosystems’ TaqPath assay and real-time PCR technology. It is designed to provide results within four hours of a sample being received by a lab. That four-hour window includes time for sample preparation and instrument analysis, according to a news release.
“The CE mark certification is an important step in combatting the outbreak of COVID-19 across Europe,” Thermo Fisher chairman, president & CEO Marc Casper said in the release. “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.”
On March 13, the FDA gave Thermo Fisher emergency use authorization (EUA) for its test to be used in certain U.S. laboratories. At the time, the company said it has 1.5 million tests available to ship under the EUA label to be distributed to approximately 200 labs in the U.S. Thermo Fisher said it expects to quickly ramp up to reach 2 million tests per week and could produce up to 5 million tests per week during April based on the availability of raw materials and an installed instrument base.
FDA amended that EUA earlier this week to include additional instruments like the real-time PCR system to expand U.S. testing capabilities from approximately 1,000 instruments to more than 3,000. The diagnostic test also won designated approvals in Canada, Singapore, India, Australia and New Zealand.