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Medical Devices / Submissions and Approvals

Biocartis Colorectal Cancer Assays Score CE Marks

Nov. 29, 2017

Biocartis’ two liquid biopsy tests for the detection of tumor DNA mutations in patients with metastatic colorectal cancer have received CE-IVD marking.

The Idylla ctNRAS-BRAF mutation test can detect 18 NRAS and five BRAF mutations, with results in 110 minutes. The Idylla ctKRAS can detect 21 KRAS mutations with results in 130 minutes.

The RAS tests, developed in collaboration with Merck KGaA, require less than a minute of hands-on time.

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