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Novacyt SARS-CoV-2 PCR Test Approved in UK Under New Regulations

NEW YORK — French diagnostics firm Novacyt said last week that its Genesig COVID-19 Real-Time PCR assay has been approved in the UK under newly implemented regulations on SARS-CoV-2 tests.

The test is designed for the qualitative detection of the SARS-CoV-2 ORF1ab gene in nasopharyngeal swabs, oropharyngeal swabs, and sputum samples. It received Emergency Use Authorization in the US and CE marking in early 2020.

Novacyt said that its test has now been added to the register of the UK's new Coronavirus Test Device Approvals amendment regulations, which require antigen-based and molecular COVID-19 tests to undergo a desktop review in order to be sold in the region. A number of other SARS-CoV-2 tests have joined the CTDA register including ones from Thermo Fisher Scientific's Life Technologies, Roche, Clent Life Science, Bruker, and Launch Diagnostics.

Earlier this month, Novacyt announced that it had submitted a total of 11 of its SARS-CoV-2 tests for review under the CTDA regulations. In addition to the now-approved Genesig test, the firm noted that PROmate 1 Gene q16 and q32 products continue to be supplied to the UK's National Health Service under a temporary protocol.

Novacyt said it has not been notified about the status of the other eight tests, which remain unavailable for sale in the UK. It said that if none of its other SARS-CoV-2 tests are added to the CTDA register, it would take a roughly £3 million ($4.0 million) hit to its full-year 2021 revenues. With the new approval, the financial impact will be "significantly lower," a company spokesperson said. 

In June, the company reported £277.2 million in revenues for 2020, which were primarily derived from its SARS-CoV-2 tests.