Biocartis’ Idylla CDx MSI Test received FDA premarket approval to detect microsatellite instability (MSI) in formalin-fixed tissue. It aids in guiding immunotherapy treatments such as Bristol Myers Squibb's Opdivo and Yervoy in colorectal and other cancers. The real-time PCR based assay provides results in approximately 2.5 hours, facilitating rapid clinical decision-making. This regulatory milestone strengthens Biocartis’ oncology companion diagnostics portfolio, aligning with the firm’s restructuring around cancer molecular testing.