Biocartis launches CE-marked IVD NRAS test for colorectal cancer
Biocartis has announced the launch of the Idylla NRAS Mutation Test. This newly launched CE-marked IVD test, alongside Biocartis' existing Idylla NRAS-BRAF Mutation Test (CE-IVD), will now allow for more flexibility in geographies where BRAF testing for metastatic colorectal cancer (mCRC) patients is not reimbursed.
Access to rapid and easy-to-use molecular diagnostic tests is essential to understand what specific gene mutations drive cancers. This allows for timely cancer treatment decision-making. About five percent of all metastatic colorectal tumors are driven by mutations in the NRAS oncogene and as such NRAS mutation testing for mCRC patients is recommended by the most recent clinical guidelines. The Idylla NRAS Mutation Test detects 18 NRAS mutations directly from a single slice of FFPE tumor tissue in approx. two hours, with less than two minutes hands-on time.
The test is yet another addition to Biocartis' colorectal cancer test offering, now consisting of three CE-marked solid biopsy tests (together detecting 44 mutations directly from a slice of FFPE tumor tissue each) and two liquid biopsy assays available for research use only (together detecting 46 mutations directly from 1 ml of blood plasma each).
Hilde Eylenbosch, Chief Commercial Officer Biocartis, commented: "The launch of the Idylla NRAS Mutation Test as a CE marked IVD test demonstrates we are on top of our customer demands. This NRAS test for colorectal cancer patients will respond to existing market needs of both laboratories and hospitals on the one hand, and our pharmaceutical partners on the other hand, in geographies where BRAF testing for metastatic colorectal cancer (mCRC) patients is not reimbursed. Additionally, it further completes our colorectal cancer test offering on Idylla, that is today already one of the most advanced, rapid and easy-to-use molecular diagnostic test offerings on the market."