Biocartis secured FDA premarket approval for its Idylla CDx MSI Test, a rapid, automated assay to identify colorectal cancer patients with microsatellite instability-high (MSI-H) who may benefit from immunotherapy. Developed with Bristol Myers Squibb, the test uses a real-time PCR platform to deliver results in under three hours with minimal hands-on time. This companion diagnostic complements treatment with BMS’s Opdivo and Yervoy, supporting faster therapeutic decisions.