For Immediate Release: March 13, 2020
Today, the U.S. Food and Drug Administration took another significant diagnostic action during the coronavirus outbreak (COVID-19). The FDA issued the fourth COVID-19 diagnostic Emergency Use Authorization (EUA) to Thermo Fisher for its TaqPath COVID-19 Combo Kit.
“This action today shows our agency’s dedication to working around the clock to review and authorize diagnostics during this public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D. “We have been engaging with test developers and encouraging them to come to the FDA and work with us. Since the beginning of this outbreak, more than 80 test developers have sought our assistance with development and validation of tests they plan to bring through the Emergency Use Authorization process. Additionally, more than 30 laboratories have notified us they are testing or intend to begin testing soon under our new policy for laboratory-developed tests for this emergency. The number of products in the pipeline reflects the significant role diagnostics play in this outbreak and the large number of organizations we are working with to bring tests to market.”
The FDA issued a EUA to Thermo Fisher for its diagnostic test within 24 hours of receiving the request. This is the second commercially distributed test to receive a EUA during the COVID-19 outbreak.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.