FDA Approves Promega OncoMate MSI Dx Analysis System as Companion Diagnostic for KEYTRUDA in MSI-High Solid Tumors

The U.S. Food and Drug Administration (FDA) has approved the Promega OncoMate^® MSI Dx Analysis System designed to identify patients with microsatellite high (MSI-H) solid tumors as a companion diagnostic designed for KEYTRUDA^®, Merck's (known as MSD outside the U.S. and Canada) anti-PD-1 therapy.

OncoMate^® MSI Dx Analysis System is a PCR-based assay designed to evaluate MSI status in solid tumor tissue. MSI status can be used to inform treatment decisions and support precision oncology strategies.

"This approval reflects our dedication to providing meaningful diagnostic advances, developed to the highest quality and regulatory standards," says Alok Sharma, Global Clinical Market Director at Promega. "Our test connects patients with the therapy most likely to help them, working alongside our pharmaceutical collaborators and the clinicians who use the result."

This approval was supported through a collaboration with Merck, which markets KEYTRUDA^®. Together, the companies are working to advance personalized medicine and expand access to diagnostics that enable informed therapeutic choices.

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. It is also an approved companion diagnostic to identify patients with microsatellite stable (MSS) endometrial carcinoma who may benefit from treatment with KEYTRUDA^® plus LENVIMA^® (Lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. These approvals apply to the United States and its territories. Promega MSI technology is also CE-marked under IVDR in the European Union and has received approval from China's National Medical Products Administration (NMPA) as a companion diagnostic to identify patients with MSI-H solid tumors who may benefit from treatment with KEYTRUDA^®.

KEYTRUDA^® is indicated for adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient cancer who have progressed following prior treatment and who have no satisfactory alternative treatment options. KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.