New Coronavirus Test Delivers Results in 4 Hours

Thermo Fisher Scientific Inc. announced the U.S. FDA issued an emergency use authorization (EUA) for its diagnostic test that can be used immediately by CLIA high-complexity laboratories to detect nucleic acid from SARS-CoV-2 coronavirus.

This virus is causing COVID-19 disease in people around the globe. 

Announced on March 13, 2020, this Thermo Fisher test uses Applied Biosystems TaqPath Assay technology and is designed to provide patient results within 4-hours of a sample being received by a lab. 

The estimated time-to-result includes time for sample preparation and instrument analysis.

The available tests will initially be distributed to approximately 200 labs in the U.S. and Thermo Fisher will continue to work in partnership with government agencies and private partners to expand access.

Marc N. Casper, chairman, president, and chief executive officer of Thermo Fisher Scientific, said in a press release, "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.”

Thermo Fisher 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 2 million tests per week. 

Based on the 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 2020.

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.

This test has not been FDA cleared or approved; however, the FDA can issue an EUA to permit the 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.

Click here for more information about the test.

Thermo Fisher Scientific Inc. delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

COVID-19 testing news published by Coronavirus Today.