CPhI Online

FDA grants EUA to Thermo Fisher’s diagnostics test for coronavirus

16 Mar 2020

The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Thermo Fisher Scientific’s diagnostic test for coronavirus, the contract development and manufacturing organisation said Monday.

The test can be used immediately by CLIA high-complexity laboratories to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19.

The company said it currently has 1.5 million tests available to ship under the EUA label and expects to quickly ramp up to 2 million tests per week.

“Based on availability of raw materials and an installed instrument base, the company expects to scale production up to 5 million tests per week during the month of April,” Thermo Fisher said in a statement. “The available tests will initially be distributed to approximately 200 labs in the US and Thermo Fisher will continue to work in partnership with government agencies and private partners to expand access.”

The test provides results within four hours of a sample being received by a lab. The estimated time-to-result also 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.,” said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific.

While the test has not been FDA-approved, the FDA can issue an EUA to allow use of certain medical products that can diagnose, treat or prevent a disease or condition when the US Department of Health and Human Services declares a public health emergency.