The U.S. Food and Drug Administration (FDA) on March 13 granted emergency use authorization (EUA) to Thermo Fisher Scientific for a diagnostic kit to test patients for COVID-19 novel coronavirus disease. Thermo joins Roche among manufacturers with an EUA for a commercial coronavirus test.
The FDA granted the EUA to Thermo Fisher's TaqPath COVID-19 combo kit, a multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) diagnostic test that can diagnose the SARS-CoV-2 virus, which causes COVID-19.
The kit consists of the TaqPath COVID-19 RT-PCR kit and the TaqPath COVID-19 control kit for simplified ordering, and it can be used to evaluate up to 94 patient specimens in under four hours, according to Thermo Fisher. The kit is approved for use with RNA that is extracted from nasopharyngeal swabs, nasopharyngeal aspirate (nasal aspirate), and bronchoalveolar lavage from patients who are at risk of exposure to the SARS-CoV-2 virus or who have symptoms of COVID-19.
The kit comes in two reaction sizes of 100 reactions and 1,000 reactions, and it is designed to be used with instruments from Thermo Fisher's Applied Biosystems division: the Applied Biosystems 7500 Fast Dx real-time PCR system and the associated Applied Biosystems COVID-19 Interpretive Software, according to Thermo Fisher.
With the FDA's nod, Thermo Fisher joins Roche Molecular Systems among diagnostics manufacturers with the FDA's imprimatur to market tests for patients suspected of having COVID-19. Also on March 13, the FDA said Roche's cobas SARS-CoV-2 test could be used for coronavirus testing.
The EUAs granted to Thermo Fisher and Roche are part of the FDA's urgent effort to make more diagnostic kits available to test for the coronavirus. The U.S. government has come under fire for what some say has been a slow response to the coronavirus outbreak, a response that has been hindered in part by a patchwork of regulations covering the diagnostics industry.
Indeed, the effort to get more coronavirus tests to market was mentioned in President Donald Trump's March 13 news conference, in which he announced a declaration of emergency to help healthcare providers and public health authorities deal with the outbreak. Trump and other speakers pointed to behind-the-scenes work between the FDA and Roche and Thermo Fisher that enabled the agency to grant EUA approval within 24 hours of receiving applications from the vendors.
In granting the Thermo Fisher EUA, the FDA noted that more than 80 diagnostic test developers have sought the agency's help in developing and validating tests they plan to bring to market using the EUA process. Another 30 labs have notified the agency that they are testing or plan to start testing under the FDA's new policy covering the use of laboratory-developed tests for the coronavirus.
"This action ... shows our agency's dedication to working around the clock to review and authorize diagnostics during this public health emergency," said FDA Commissioner Dr. Stephen Hahn in a statement released by the FDA.