11/11/2025 12:00
FDA Approves Promega OncoMate® MSI Dx Analysis System as Companion Diagnostic for KEYTRUDA® in Combination with LENVIMA® In Advanced Endometrial Carcinoma

The U.S. Food and Drug Administration (FDA) has approved the Promega OncoMate® MSI Dx Analysis System as a companion diagnostic designed to identify patients with microsatellite stable (MSS; defined as not MSI-high [not MSI-H]) endometrial carcinoma who may benefit from treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. This is the first Promega companion diagnosti...