Emergency Use Authorization Issued to Second COVID-19 Test for Commercial Distribution

Officials with the FDA have issued Emergency Use Authorization (EUA) to Thermo Fisher Scientific’s new diagnostic test for detecting the novel coronavirus (COVID-19).^1,2 The TaqPath COVID-19 Combo Kit is the second test with EUA for commercial distribution for detecting this virus, and the fourth overall to be authorized for emergency use by the agency.¹

Thermo Fisher’s test is designed to provide patient results within 4 hours of a sample being received by a lab. The estimated time-to-result also includes time for sample preparation and instrument analysis, according to the company.²

According to the FDA, the EUA to Thermo Fisher was issued within 24 hours of the agency’s receiving the request. FDA Commission Stephen M. Hahn, MD, said the action demonstrates the agency’s dedication to working around the clock to review and authorize diagnostics during the COVID-19 public health emergency. He said test developers are being encouraged to work with the agency.¹

“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,” said Hahn, in a prepared statement.¹ “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.”

EUA is not a product approval, but rather allows the test to be utilized as a means for addressing a public health emergency. According to Thermo Fisher, its test is only authorized for the duration of the need to address the public health emergency, unless the authorization is terminated or revoked sooner.²

On March 12, 2020, the FDA issued an EUA to Roche Molecular Systems for its cobas SARS-CoV-2 test, the first to be authorized for commercial distribution for emergency COVID-19 testing.³

REFERENCES

• Coronavirus (COVID-19) Update: FDA Issues Emergency Use Authorization to Thermo Fisher. [news release]. Silver Spring, MD; March 13, 2020: FDA website. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-thermo-fisher. Accessed March 14, 2020.
• FDA Issues Emergency Use Authorization to Thermo Fisher Scientific for Diagnostic Test Used to Detect COVID-19 [news release]. Waltham, MA; March 13, 2020: Thermo Fisher website. http://thermofisher.mediaroom.com/2020-03-13-FDA-Issues-Emergency-Use-Authorization-to-Thermo-Fisher-Scientific-for-Diagnostic-Test-Used-to-Detect-COVID-19. Accessed March 14, 2020.
• Murphy J. FDA, Pharmacies Take Action in Preparing for COVID-19 Outbreak. Pharmacy Times. https://www.pharmacytimes.com/news/fda-pharmacies-take-action-in-preparing-for-covid-19-outbreak. Published March 13, 2020. Accessed March 14, 2020.