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Novacyt Gets CE Mark for Coronavirus, Flu, RSV Combo Panel

NEW YORK — French diagnostics firm Novacyt said on Thursday that it has received CE marking for its Winterplex PCR-based respiratory panel, which can differentiate SARS-CoV-2 from common winter infections.

Winterplex includes two gene targets specific to SARS-CoV-2, as well as gene targets for influenza A and B and respiratory syncytial virus. According to Novacyt, Winterplex has demonstrated 100 percent specificity and 96 percent to 100 percent sensitivity across the panel in clinical testing.

The panel can run on any open PCR platform including Novacyt's portable q32 instrument.

In March, Novacyt's Primerdesign business received Emergency Use Authorization from the US Food and Drug Administration for an RT-PCR-based SARS-CoV-2 test. Last month, Novacyt reported a sharp jump in revenues for the first half of 2020 on demand for the test and related products.