FDA Approves Promega OncoMate MSI Dx as a Companion Diagnostic for Keytruda: PCR-Based Test Evaluates Microsatellite Instability in Solid Tumors
Madison, Wisconsin — The U.S. Food and Drug Administration has approved Promega's OncoMate MSI Dx Analysis System as a companion diagnostic to identify patients with microsatellite instability-high (MSI-H) solid tumors who may be eligible for treatment with pembrolizumab (Keytruda), in an approval announced by the company on November 10.
The OncoMate MSI Dx Analysis System, developed by Promega Corporation in collaboration with Merck, is a polymerase chain reaction based assay that evaluates microsatellite instability status in solid tumor tissue.
Keytruda's related indication covers adult and pediatric patients with unresectable or metastatic MSI-H or mismatch repair-deficient solid tumors that have progressed following previous treatment and who have no satisfactory alternative options, which received full FDA approval in March 2023.
The system was previously cleared by the FDA to identify patients with colorectal cancer who may benefit from additional testing for Lynch syndrome, and is also an approved companion diagnostic for identifying patients with microsatellite-stable endometrial carcinoma. The company said the approval applies to the United States and its territories. This report covers the approval and published product information only and offers no individual treatment advice.
Source: Promega
Published by GSM · USA (original Chinese edition)
Photo: 图：实验室人员将 PCR 混合液装入热循环仪（示意图）。作者与授权：26Isabella，CC BY 4.0，维基共享资源。 / Photo: Loading PCR mixture into a thermocycler (illustrative image). Wikimedia Commons (26Isabella, CC BY 4.0).
