FDA clears Promega's OncoMate as a Keytruda companion diagnostic

> The FDA has approved the Promega OncoMate MSI Dx Analysis System as a companion diagnostic for Merck's KEYTRUDA in MSI-high solid tumors.

OncoMate is a PCR-based assay that reads microsatellite instability status from solid tumor tissue, a signal used to steer treatment decisions in precision oncology. Promega says the approval was supported through its collaboration with Merck, which markets the anti-PD-1 therapy KEYTRUDA and calls it MSD outside the U.S. and Canada.

Alok Sharma, Promega's Global Clinical Market Director, framed the clearance as a patient-matching win. The test, he said, connects patients with the therapy most likely to help them, working alongside the company's pharmaceutical collaborators and the clinicians who read the result. Sharma also said the approval reflects Promega's push to deliver diagnostic advances built to high quality and regulatory standards.

It's not OncoMate's first regulatory lap. The FDA previously cleared it as the first PCR-based molecular diagnostic for spotting colorectal cancer patients who may benefit from further testing to diagnose Lynch syndrome, and it already serves as an approved companion diagnostic for microsatellite stable endometrial carcinoma patients who may benefit from KEYTRUDA plus LENVIMA, the oral multiple receptor tyrosine kinase inhibitor discovered by Eisai.

The new green light covers the United States and its territories. Promega's MSI technology also carries a CE mark under IVDR in the European Union and has been approved by China's National Medical Products Administration as a companion diagnostic for MSI-H solid tumor patients who may benefit from KEYTRUDA.

KEYTRUDA is indicated for adult and pediatric patients with unresectable or metastatic MSI-H or mismatch repair deficient cancer who have progressed after prior treatment and have no satisfactory alternative options. Promega is headquartered in Madison, Wisconsin, with branches in 16 countries and more than 50 global distributors.