NEW YORK – Novacyt said on Monday that its molecular test for the COVID-19 virus has received CE marking.
The company's molecular division, Primerdesign, has launched the test, which follows the launch of Novacyt's research-use-only coronavirus test on Jan. 31. Laboratories and hospitals can use the clinical test on patients without the need for validation by clinicians, according to Paris-based Novacyt.
The firm said that it has received 288,000 requests for quotations for the test since it was made available for preorder on Feb. 14. The test is being formally evaluated by public health authorities in five countries, and Novacyt is in discussions with them to support their national screening requirements for the 2019-nCoV virus.
The company has submitted its test to the US Food and Drug Administration for Emergency Use Authorization.