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Novacyt Gets CE Mark for Multigene SARS-CoV-2 Test, Launches RUO Variant Assay

NEW YORK — French diagnostics firm Novacyt said on Thursday that it has received CE marking for its Genesig COVID-19 3G test, a three-gene assay for SARS-CoV-2.

According to Novacyt, the RT-PCR-based test is designed to detect the ORF1ab, M, and S genes of the virus and builds on the company's portfolio of one-gene, two-gene, and high-throughput SARS-CoV-2 tests.

Novacyt also said that it has launched a research-use-only assay designed to detect four biologically significant immune escape mutations of the virus including E484K, K417N, K417T and P681R, which are present in the Alpha, Beta, Gamma, and Delta variants of concern. Called SNPsig EscapePLEX SARS-CoV-2, the test also detects the SARS-CoV-2 ORF1ab and M genes to provide confirmatory detection.

"Our Genesig COVID-19 portfolio is highly accurate despite mutations, and we believe our SNPsig portfolio is the world’s largest for detecting SARS-CoV-2 variants," Novacyt CEO Graham Mullis said in a statement. "The addition of both of these new assays ensures that Novacyt's COVID-19 solutions remain robust and that pragmatic options are available to support both public health and private sector testing alike."

In March, Novacyt announced the expected receipt of CE marking for SNPsig VariPlex, which detects multiple SARS-CoV-2 variants of concern. It also recently received the CE mark for COVID-HT Direct, a high-throughput SARS-CoV-2 test that does not require nucleic acid extraction.