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Biocartis Gets CE Mark for Idylla NRAS-BRAF Mutation Test

NEW YORK (GenomeWeb) – Biocartis said today that its tissue-based Idylla NRAS-BRAF mutation test has been CE marked and can now be sold throughout the European Economic Area.

According to the company, the combination of the new NRAS-BRAF mutation test with its existing KRAS assay means that it can offer customers a complete solution for clinical testing of metastatic colorectal cancers, as recommended by the most recent professional guidelines.

Biocartis also highlighted the ability of its suite of RAS tests to enable same-day results, allowing faster treatment selection for patients.

Applicable to formalin-fixed paraffin embedded tumor tissue, the newly CE-marked NRAS-BRAF test is fully automated and combines detection of 18 NRAS and 5 BRAF mutations. The existing KRAS mutation test detects another 21 mutations.

"Biocartis now has a full CE-marked colorectal cancer mutations test panel [that] allows for complete same-day testing and treatment selection for mCRC patients," Biocartis CEO Rudi Pauwels said in a statement. "As such, we expect this CE marking to add substantial traction to our commercial cartridge consumption."

In addition to the two tests for colorectal cancer, Biocartis also offers a CE-marked assay for BRAF mutations in melanoma as well as a research-use-only assay for EGFR mutations in lung cancer biopsy tissue. More recently, it has also launched two RUO liquid biopsy assays for blood-based detection of BRAF and KRAS mutations that it also hopes to CE mark for clinical use.

Researchers working with the BRAF liquid biopsy assay recently showed that it could detect mutations with high sensitivity compared to tissue samples, and with identical results to other PCR-based liquid biopsy technologies like ddPCR or BEAMing.

In November, the company said it had signed a distribution agreement giving Thermo Fisher US distribution rights for the Idylla platform and assays. Biocartis retains the right to sell the technology via direct sales channels.