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

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

"This approval reflects our commitment to delivering meaningful diagnostic breakthroughs, developed to the highest quality and regulatory standards," said Alok Sharma, Global Head of Clinical Market at Promega. "Our trial connects patients to the therapy that is most likely to help them, in collaboration with our pharmaceutical partners and the clinicians who use the results."

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

The OncoMate MSI Dx Analysis System was previously approved by the FDA as the first PCR-based molecular diagnostic to identify colorectal cancer patients who could benefit from additional testing to diagnose Lynch syndrome. It is also an approved adjunct diagnostic to identify patients with microsatellite stability endometrial carcinoma (MSS) who could benefit from treatment with KEYTRUDA plus LENVIMA (Lenvatinib), the oral multiple receptor tyrosine kinase inhibitor discovered by Eisai. These approvals apply to the United States and its territories. Promega's MSI technology is also CE marked in accordance with 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 solid tumors with MSI-H who could benefit from KEYTRUDA treatment. ^®®®®

KEYTRUDA is indicated for adult and pediatric patients with either unresectable or metastatic cancer that has MSI-H or DNA mismatch repair (dMMR) system deficiency and whose disease has progressed after prior treatment, with no other satisfactory treatment options. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. ^®®