Diagnostics firm Biocartis has received CE-IVD marking for two of its liquid biopsy tests, the Belgian company has announced.
The two tests can detect RAF mutations in tumour DNA from patients with metastatic colorectal cancer (mCRC). The Idylla ctNRAS-BRAF mutation test detects 18 NRAS and five BRAF mutations while the Idylla ctKRAS Mutation Test detects 21 KRAS mutations. This is the first time Biocartis has received EC-IVD certification for its liquid biopsy assays
In January 2016 the company began a collaboration with Merck to develop and commercialise its range of PCR-based diagnostic platforms. The Germany pharmaceutical company market Erbitux (cetuximab) outside the US and Canada. The drug is a type of anti-EGFR therapy which has been shown to benefit patients with RAS wild-type tumours, associated with metastatic colorectal cancer.
Erwin Sablon, Biocartis’ head of R&D and alliance management affirmed the benefits of liquid biopsy testing in precision medicine. “Liquid biopsy testing is at the advanced edge of oncology practice, where it has the ability to complement tissue testing and provide additional prognostic information that was not available to clinicians so far,” he said. “With these tests we can now further improve the health outcome of mCRC patients across the world.”