Biocartis obtained EU In Vitro Diagnostic Regulation (IVDR) Class C certification for its Idylla CDx MSI cartridge, clearing a regulatory hurdle for use across Europe. The automated PCR test identifies microsatellite instability in metastatic colorectal cancer and supports treatment selection for immune‑checkpoint regimens from Bristol Myers Squibb. The certification complements the Idylla system’s earlier U.S. FDA clearance and expands Biocartis’ clinical footprint. The cartridge runs on a rapid, cartridge‑based platform with minimal hands‑on time, enabling faster diagnostic workflows in clinical pathology labs. Clinicians and cancer centers now have an IVDR‑certified, automated option for MSI testing that can integrate into treatment decision pathways where MSI status determines immunotherapy eligibility.