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Novacyt to Get CE Mark for SARS-CoV-2 Variant Test

This article has been updated to note that Novacyt has not yet received the CE mark for the test but expects it will later this week.

NEW YORK — Novacyt said on Wednesday that it will receive the CE mark for SNPsig VariPlex, a PCR-based test designed to detect multiple SARS-CoV-2 variants of concern, this week.

According to the French diagnostics firm, the genotyping test detects four SARS-CoV-2 variants — first identified in the UK, South Africa, Brazil, and California, respectively — and two biologically significant mutations, all of which are now prevalent globally.

Novacyt said the test can be deployed in point-of-care settings and provides results in under two hours when used with its q32 instruments or by a lab using an open platform instrument capable of detection across at least four fluorescent channels.

Novacyt said it is making a research-use-only version of the test available for epidemiological applications and that it intends to pursue emergency use authorizations for it in various countries.

Earlier this year, Novacyt received CE marking for a next-generation high-throughput PCR test for COVID-19. The company also recently received CE marking for a test that can differentiate SARS-CoV-2 from flu and other respiratory infections.