The assay identifies patients with microsatellite instability-high solid tumors who may be eligible for treatment with the immunotherapy.
The US Food and Drug Administration (FDA) has approved the Promega OncoMate MSI Dx Analysis System as a companion diagnostic for Keytruda, the anti-PD-1 therapy from Merck, which is known as MSD outside the US and Canada. The test is designed to identify patients with microsatellite instability-high (MSI-H) solid tumors.
The OncoMate MSI Dx Analysis System is a PCR-based assay that evaluates MSI status in solid tumor tissue. According to Promega, MSI status can 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, in a release. “Our test connects patients with the therapy most likely to help them, working alongside our pharmaceutical collaborators and the clinicians who use the result.”
The approval was supported through a collaboration with Merck, which markets Keytruda. The companies say they are working to advance personalized medicine and expand access to diagnostics that enable informed therapeutic choices.
Earlier Approvals and Clearances
The assay has a history of regulatory decisions in the US and abroad. The FDA previously cleared it as the first PCR-based molecular diagnostic to identify patients with colorectal cancer who may benefit from additional testing for Lynch syndrome. It is also an approved companion diagnostic for identifying patients with microsatellite stable endometrial carcinoma who may benefit from Keytruda plus LENVIMA (lenvatinib), an orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. These approvals apply to the US and its territories.
Outside the US, Promega MSI technology is CE-marked under the European Union’s In Vitro Diagnostic Regulation. It has also received approval from China’s National Medical Products Administration as a companion diagnostic to identify patients with MSI-H solid tumors 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 following prior treatment and have no satisfactory alternative treatment options.
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