MADISON, Wisconsin — The U.S. Food and Drug Administration has approved the Promega OncoMate MSI Dx Analysis System as a companion diagnostic for identifying patients with microsatellite stable (MSS), or non–MSI-high, endometrial carcinoma who may be eligible for treatment with KEYTRUDA (pembrolizumab) in combination with LENVIMA (lenvatinib). This marks the first FDA-approved companion diagnostic developed by Promega.
The OncoMate MSI Dx Analysis System is a PCR-based assay used to determine microsatellite instability (MSI) status in tumor tissue. Determining MSI status can support treatment planning and help guide precision oncology strategies in patients with endometrial cancer.
“This approval underscores the critical role diagnostics play in accurately matching the right patients, at the right time with the right therapy,” said Alok Sharma, Global Clinical Market Director at Promega. “We are committed to delivering reliable tools that guide clinical decisions and help improve patient outcomes.”
The approval follows a collaboration with Merck, which markets KEYTRUDA plus LENVIMA in partnership with Eisai Co., Ltd. The companies continue to work together to support personalized medicine approaches and expand access to diagnostic tools that enable informed therapeutic decisions.
The OncoMate MSI Dx Analysis System was previously cleared by the FDA as the first PCR-based molecular diagnostic to help identify colorectal cancer patients who may require additional testing to diagnose Lynch syndrome. Promega’s MSI technology has also received regulatory approvals in the European Union and China.
