Madison, WI — November 11, 2025 — Leads & Copy — The U.S. Food and Drug Administration (FDA) has approved Promega’s OncoMate® MSI Dx Analysis System as a companion diagnostic to identify endometrial carcinoma patients with microsatellite stable (MSS) tumors, who may benefit from treatment with Merck’s KEYTRUDA® (pembrolizumab) plus Eisai’s LENVIMA® (lenvatinib).
The OncoMate® MSI Dx Analysis System is the first Promega companion diagnostic to receive FDA approval. It is a PCR-based assay designed to evaluate MSI status in tumor tissue, which can then be used to guide treatment decisions and support precision oncology strategies in endometrial carcinoma.
Alok Sharma, Global Clinical Market Director at Promega, emphasized the critical role of diagnostics in personalized medicine. Sharma stated the approval underscores the importance of accurately matching patients with the right therapy at the right time and that Promega is committed to providing reliable tools that guide clinical decisions and improve patient outcomes.
The FDA approval was supported through a collaboration with Merck, which markets KEYTRUDA plus LENVIMA in collaboration with Eisai Co., Ltd. Together, the companies aim to advance personalized medicine and expand access to diagnostics for informed therapeutic choices.
The OncoMate® MSI Dx Analysis System was previously cleared by the FDA as the first PCR-based molecular diagnostic for identifying colorectal cancer patients who may benefit from additional testing to diagnose Lynch syndrome. The current approval applies to the United States and its territories. Promega MSI technology has also received regulatory approvals in China and the European Union.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
Alok Sharma, Global Clinical Market Director at Promega
Source: Promega Corporation
Source: Promega Corporation
