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Biocartis Obtains CE-IVD Mark for MDx Platform, BRAF Mutation Test

NEW YORK (GenomeWeb) – Biocartis today announced it has obtained CE-IVD marking for and commercially launched the Idylla molecular diagnostics platform and BRAF Mutation Test.

Idylla is a fully automated real-time PCR system that allows clinicians to perform molecular testing at any time without the need for batching or for trained personnel. It can produce test results in 35 minutes to two hours, enabling same-day results, and its multiplex capability allows for the detection of up to 30 targets with the same sample, the company said.

The BRAF Mutation Test is for determining the most appropriate treatment for a specific type of skin cancer and can detect mutations from formalin-fixed, paraffin-embedded tissue slices in about 90 minutes. In a statement, Biocartis CEO and Chairman Rudi Pauwels noted that the company is also working with Janssen Pharmaceutica and Abbott to develop additional tests in other disease areas.

Mechelen, Belgium-based Biocartis said last week that it raised €64.5 million ($84 million) in a private financing round. It also formed a joint venture with Pronota called MyCartis to commercialize the Evaluation multiplex system for rapid and cost-effective detection of protein and nucleic acid biomarkers.