Biocartis received FDA premarket approval for its Idylla CDx MSI test designed to identify colorectal cancer patients with microsatellite instability-high tumors who may benefit from immunotherapy with Bristol Myers Squibb’s Opdivo and Yervoy. The assay, developed with BMS, uses a rapid PCR cartridge detecting seven biomarkers with minimal hands-on time and results in under three hours. This advance supports precision oncology by facilitating timely and accurate biomarker assessment, critical for appropriate immunotherapy patient selection.