Posted by Michael Wonder on 13 Nov 2025
FDA approves Promega OncoMate MSI Dx analysis system as companion diagnostic for Keytruda in combination with Lenvima in advanced endometrial carcinoma
11 November 2025 - The US FDA has approved the Promega OncoMate MSI Dx Analysis System as a companion diagnostic designed to identify patients with microsatellite stable (MSS; defined as not MSI-high [not MSI-H]) endometrial carcinoma who may benefit from treatment with Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, plus Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai.
This is the first Promega companion diagnostic to receive FDA approval.
