The Food and Drug Administration (FDA) has issued an Emergency Use Authorization to Thermo Fisher for its TaqPath COVID-19 Combo Kit, a diagnostic test that detects nucleic acid from SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19).
The test can be used immediately by CLIA high-complexity labs in the US and is designed to provide patient results within 4 hours of a sample being received by a lab. The kit is approved for use with RNA extracted from nasopharyngeal swabs, nasopharyngeal aspirate, and bronchoalveolar lavage from patients at risk of exposure to the SARS-CoV-2 virus or with signs and symptoms of COVID-19.
The FDA issued the Emergency Use Authorization for Thermo Fisher’s diagnostic test within 24 hours of receiving the request.
“We have been engaging with test developers and encouraging them to come to the FDA and work with us,” said FDA Commissioner Stephen M. Hahn, MD. “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.”
The TaqPath COVID-19 Combo Kit is the second commercially distributed test to receive Emergency Use Authorization during the outbreak. Last week, the FDA authorized the Roche cobas SARS-CoV-2 Test, which is run on Roche’s widely available cobas® 6800 and cobas® 8800 Systems.
For more information visit fda.gov.