Thermo Fisher Scientific Inc., Waltham, Mass., announces that on March 13 the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for its diagnostic test that can be used immediately by CLIA high-complexity laboratories in the United States to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19, and not for any other viruses or pathogens.
The EUA test is optimized for use on the company’s Applied Biosystems 7500 Fast Dx Real-time PCR instrument, which is covered under the EUA and already used in clinical laboratories worldwide. The authorized test uses Applied Biosystems TaqPath Assay technology and is designed to provide patient 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.
Thermo Fisher has also provided an update on its anticipated production rate. The company currently has 1.5 million tests available to ship under the EUA label, and expects to quickly ramp up to reach two million tests per week. Based on availability of raw materials and an installed instrument base, the company expects to scale production up to five million tests per week during the month of April.
The available tests will initially be distributed to approximately 200 labs in the United States, and Thermo Fisher will continue to work in partnership with government agencies and private partners to expand access.
This test has not been FDA cleared or approved; however, the FDA can issue an EUA to permit use of certain medical products that may be effective in diagnosing, treating, or preventing a disease or condition (as in the case of the novel coronavirus), when the secretary of the U.S. Department of Health and Human Services (HHS) declares a public health emergency. HHS Secretary Alex Azar declared an emergency for COVID-19 on January 31.
The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
For more information about the test, visit www.thermofisher.com/COVID19EUA
