The U.S. Food and Drug Administration (FDA) issued its fourth COVID-19 related diagnostic Emergency Use Authorization (EUA) this week, tapping Thermo Fisher for its TaqPath diagnostic test.
The TaqPath Combo Kit contains both assays and controls necessary to detect RNA from the SARS-CoV-2 virus in real-time. Thermo Fisher notes that the kit is useable both by clinical and public health labs and will enable them to evaluate as many as 94 patient specimens in less than 4 hours.
“We have been engaging with test developers and encouraging them to come to the FDA and work with us,” FDA Commissioner Stephen Hahn said. “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.”
Moving quickly, the FDA issued the EUA within 24 hours after receiving a request from Thermo Fisher.