Biocartis has achieved FDA premarket approval for its Idylla Cdx MSI Test, designed to identify colorectal cancer patients with microsatellite instability-high (MSI-H) tumors who may benefit from immunotherapy treatments such as Bristol Myers Squibb’s Opdivo and Yervoy. Developed in partnership with BMS, this rapid, automated PCR-based test delivers results in under three hours with minimal hands-on time. The approval enhances precision oncology options by facilitating timely patient stratification and treatment selection, reinforcing Biocartis’ position in companion diagnostics.