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# FDA OKs Companion Diagnostic for Endometrial Cancer Therapy
- URL: https://www.fdaweb.com/fda-oks-companion-diagnostic-for-endometrial-cancer-therapy/
- Published: 2025-11-12T12:00:00.000Z
- Updated: 2026-09-14T15:26:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160208

FDA has approved Promega’s OncoMate MSI Dx Analysis System as a companion diagnostic for identifying patients with microsatellite stable endometrial carcinoma who may benefit from treatment with Merck’s Keytruda (pembrolizumab) in combination with Eisai’s Lenvima (lenvatinib). The polymerase chain reaction-based assay is designed to determine microsatellite instability (MSI) status in tumor tissue, helping oncologists tailor immunotherapy treatment strategies for advanced endometrial cancer patients, according to Promega. Assessing MSI status, a biomarker linked to tumor mutation rates and response to immunotherapy, can help guide treatment selection and predict response to checkpoint inhibitors such as Keytruda, it adds.