The U.S. Food and Drug Administration (FDA) has granted approval to the Promega OncoMate® MSI Dx Analysis System as a companion diagnostic for identifying patients with microsatellite stable (MSS) endometrial carcinoma who may benefit from treatment with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with LENVIMA® (lenvatinib), an oral multiple receptor tyrosine kinase inhibitor developed by Eisai. This marks the first FDA-approved companion diagnostic from Promega and represents a significant step in advancing precision oncology for endometrial cancer.
The OncoMate® MSI Dx Analysis System is a polymerase chain reaction (PCR)-based assay developed to determine microsatellite instability (MSI) status in tumor tissue. Determining MSI status is critical in guiding therapeutic decisions, particularly for identifying patients likely to respond to specific immunotherapy combinations. In this case, it enables clinicians to accurately select patients with microsatellite stable tumors who may benefit from pembrolizumab plus lenvatinib therapy.
The FDA approval is the result of a collaboration between Promega, Merck, and Eisai, aimed at advancing personalized treatment strategies and expanding access to molecular diagnostics that inform cancer therapy decisions. This partnership exemplifies the growing integration of diagnostic innovation with targeted therapeutics to improve patient outcomes and optimize the use of immunotherapies.
Previously, the OncoMate® MSI Dx Analysis System was cleared by the FDA as the first PCR-based molecular diagnostic for identifying colorectal cancer patients who may benefit from further testing for Lynch syndrome, an inherited cancer predisposition condition. Its expanded approval for use in endometrial carcinoma broadens the system’s clinical application and reinforces its value in precision medicine.
Promega’s MSI technology is already recognized globally, with additional regulatory approvals in China and the European Union. The latest FDA approval further strengthens the company’s position in the molecular diagnostics landscape, emphasizing its contribution to advancing biomarker-driven cancer care. By enabling more precise identification of patients eligible for combination immunotherapy, the OncoMate® MSI Dx Analysis System enhances clinicians’ ability to personalize treatment and supports ongoing efforts to integrate diagnostics into every stage of cancer management.
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