Novacyt COVID-19 Diagnostic Gains FDA Emergency Use Authorization

Novacyt COVID-19 Diagnostic Gains FDA Emergency Use Authorization
Coronavirus positive test results

A U.K.-based division of clinical diagnostics company Novacyt announced Monday that it was granted an Emergency Use Authorization (EUA) by the FDA for its COVID-19 diagnostic test. Developed by the company’s molecular diagnostics division Primerdesign, the test is available for immediate distribution to hospitals and laboratories in the U.S.

The company said its test has a handful of specific benefit that include a sample-to-answer time of around two hours, can be used with multiple testing platforms common to diagnostics labes, and the fact the test is lyophilized—or freeze-dried—which allows the test kits to be shipped at ambient temperatures.

“The US FDA EUA authorization is another important endorsement of the performance and quality of our COVID-19 test and demonstrates once again Novacyt’s growing role in tackling this pandemic,” said Graham Mullis, CEO of Novacyt, in a press release. “We are committed to providing clinicians around the world with our COVID-19 test and delighted we can now support the US market.”

Under the EUA designation, the Primerdesign test is authorized only for the detection of RNA from SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus infection, and not for any other viruses or pathogens. It will remain authorized for the duration of the declaration that circumstances exist justifying its emergency use for detection of SARS-CoV-2 virus, unless the authorization is terminated or revoked sooner by the FDA.

The test was originally released on January 31 as a research use only (RUO) test, and received a CE-Mark for diagnostic use on February 17. Novacyt also announced that the RUO COVID-19 test was approved for use by the Indonesian Ministry of Health.