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Biotech company Novacyt has applied to the US Food and Drug Administration for the Emergency Use Approval for its novel coronavirus (2019-nCoV) test, developed by its subsidiary Primerdesign.
The approval will enable the use of nCoV test for clinical diagnostic testing in laboratories temporarily.
The company claims that it is working with the FDA to indicate consistency and performance of the test for emergency use.
Novacyt is also in discussion with several NHS hospitals and Public Health England on the nCoV test.
The firm has already sold a limited number of tests to some hospitals so that they can validify.
Since the declaration of 2019-nCoV outbreak as a global emergency on 30 January 2020 by the WHO, the company claims that it has seen strong demand for its nCoVtest.
The test, launched on 31 January, has already secured orders for 33,000 tests. It also received requests for quotations for another 32,000 tests from over 30 countries.
Primerdesign believes that it will be one of the first companies to market its test with CE-Mark approval.
Novacyt CEO Graham Mullis said: “It is still early days in this public health emergency, however coronavirus has already been reported in 23 countries with more than 28,000 reported infections. 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.
“In addition, we look forward to launching our CE-Mark approved nCoV test, which we believe provides laboratories with a fast and reliable nCoV test without the need to carry out their own validation.
“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 to support clinicians in reducing the spread of the disease.”
Deaths from the new coronavirus have reached 638, as of the end of 6 February. The toll increased with 73 new deaths in mainland China, including 69 in Hubei province, most affected by the outbreak.
The total number of confirmed coronavirus cases is 31,428, including 31,161 in mainland China, reported NHC. A total of 4,821 cases are in serious condition in mainland China, with 26,359 suspected cases in the region.