Novacyt to launch CE-marked test for 2019-nCoV, seek emergency FDA approval

Novacyt announced Friday that amid "strong demand" for its research-use-only genesig 2019-nCoV detection kit, it plans to launch a CE-marked test for the novel coronavirus in the week of February 17, allowing it to be used for clinical diagnostic testing, as well as expanding its use within laboratories. In addition, the company said it has applied to the FDA for emergency-use approval of the test, sending shares up as much as 24% on the news.

CEO Graham Mullis remarked that "as one of the first companies to develop and launch a test to detect the 2019 strain of nCoV, we have received unprecedented interest in our test and anticipate demand continuing to grow." He added that "we continue to support our new and existing customers, and are working with the various regulatory authorities to try to make our nCoV test available to as many countries and laboratories as possible." The genesig 2019-nCoV was launched last month.

According to Novacyt, its Primerdesign subsidiary has received orders for 33,000 tests and requests for quotations for another 32,000 from over 30 countries, noting that the company is "well placed to support the growing global demand for nCoV testing." Novacyt said it is "working with the FDA in order to demonstrate the consistency and performance of the Primerdesign test for emergency use."

The company added that it is also in discussions with various NHS hospitals and Public Health England regarding the 2019-nCoV test, and has sold a "limited number" to certain hospitals for their validation purposes. The test is designed to detect only the 2019 strain of the virus, which Novacyt believes "differentiates it from a number of current tests [that] are less specific and could, therefore…potentially [give] rise to a false diagnosis."

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