FDA Approves New Diagnostic for MSI-H Solid Tumors to Guide Pembrolizumab Treatment

The FDA has approved the OncoMate MSI Dx Analysis System, a companion diagnostic designed to identify patients with microsatellite instability–high (MSI-H) solid tumors. This PCR-based assay provides laboratories with an FDA-approved method to determine MSI status, enabling more precise treatment guidance for pembrolizumab (Keytruda) in oncology.