CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
April 23, 2021—Roche announced FDA approval of the Ventana MMR RxDx Panel for advanced or recurrent endometrial cancer patients. Testing can identify patients eligible for treatment with JEMPERLI (dostarlimab-gxly) monotherapy, an anti-PD1 immunotherapy from GlaxoSmithKline that was FDA approved on April 22.
The Ventana MMR RxDx Panel is a qualitative immunohistochemistry test intended for use in the assessment of mismatch repair proteins MLH1, PMS2, MSH2, and MSH6 in formalin-fixed, paraffin-embedded endometrial carcinoma tissue by light microscopy. The OptiView DAB IHC detection kit is used for MLH1, MSH2, and MSH6, and the OptiView DAB IHC detection kit with the OptiView amplification kit is used for PMS2 on a Ventana BenchMark Ultra instrument.