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C4Diagnostics Gets CE Mark for Saliva-Based Molecular SARS-CoV-2 Test

NEW YORK — C4Diagnostics of France said on Tuesday that it has received the CE mark for its saliva-based C4Covid-19 Human test for SARS-CoV-2.

The RT-LAMP-based test is designed to detect two SARS-CoV-2 genes in saliva samples. It can run on portable reader-analyzers and provides results within 30 minutes, the company said.

According to C4Diagnostics, based in Marseille, the test can identify the wild-type form of the virus as well as the main variants that originated in the UK, South Africa, and Brazil. In clinical testing, it has shown 86 percent sensitivity and 97.5 percent specificity.

In early 2020, C4Diagnostics raised €2.3 million ($2.8 million) in Series A funding. Later that year, the company launched a point-of-care SARS-CoV-2 test in partnership with Bertin Technologies and Enalees.