The U.S. Food and Drug Administration (FDA) has approved the OncoMate® MSI Dx Analysis System as a companion diagnostic, which marks the first time this type of approval has been granted to a Promega.

This PCR-based assay is specifically designed to evaluate microsatellite instability (MSI) status in tumor tissue, which is crucial for guiding treatment decisions in precision oncology, particularly for endometrial carcinoma.

The system's approval supports its use in identifying patients with microsatellite stable (MSS; defined as not MSI-high) endometrial carcinoma who may be eligible for treatment with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), combined with Eisai's orally available multiple receptor tyrosine kinase inhibitor, LENVIMA® (lenvatinib).

This significant regulatory milestone was achieved through a collaboration with Merck, which, in partnership with Eisai, markets the KEYTRUDA plus LENVIMA combination and is committed to advancing personalized medicine by expanding access to informed diagnostic tools. Promega's Global Clinical Market Director, Alok Sharma, emphasized that this approval highlights the essential role of diagnostics in accurately matching the right patients with the right therapy to improve outcomes. Furthermore, the OncoMate® MSI Dx Analysis System had already secured prior FDA clearance as the first PCR-based molecular diagnostic for identifying colorectal cancer patients who require additional testing to diagnose Lynch syndrome, and the underlying Promega MSI technology has also received regulatory approvals in the European Union and China.