FDA has issued an emergency use authorization (EUA) for the covid-19 test from Novacyt, Vélizy-Villacoublay, France. As a result, hospitals and laboratories in the United States will be able to use the test for clinical diagnosis of covid-19. The test is available for immediate distribution into the US market.
Primerdesign, Novacyt’s molecular diagnostics division, launched the covid-19 test as a research use only test on January 31, and as a CE marked test on February 17. The test produces results in less than 2 hours, and because it is lyophilized, it is stable to be shipped at ambient temperature. It can be used on multiple ubiquitous clinical laboratory instrument platforms.
“The FDA EUA 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,” says Graham Mullis, chief executive officer of Novacyt. “We are committed to providing clinicians around the world with our covid-19 test and delighted we can now support the US market.”
For more information, visit Novacyt.