The test enables the detection of patients eligible for treatment with Jemperli monotherapy from GlaxoSmithKline
The companion diagnostic (CDx) uses a comprehensive panel of DNA MMR biomarkers tested by immunohistochemistry (IHC). (Credit: F. Hoffmann-La Roche Ltd)
Roche has secured approval from the US Food and Drug Administration (FDA) for its VENTANA MMR RxDx Panel to detect advanced or recurrent endometrial cancer patients for immunotherapy.
MMR is a molecular mechanism that helps to correct certain errors that can spontaneously occur during DNA replication.
The VENTANA MMR RxDx Panel is designed to enable a fully automated, easy-to-use MMR test for the detection of patients eligible for treatment with Jemperli (dostarlimab-gxly) monotherapy.
Jemperli is an anti-PD1 immunotherapy from GlaxoSmithKline (GSK) that was approved by the FDA in April this year.
Endometrial cancer is found to be the most common gynecologic cancer in the US and the fourth most common cancer in women in North America.
Roche Diagnostics CEO Thomas Schinecker said: “We are excited to launch this companion diagnostic test with GSK to help recurrent or advanced endometrial cancer patients with limited treatment options.
“This test provides clinicians with an effective tool to identify patients best suited for treatment with GSK’s JEMPERLI, providing a new therapeutic option for women with MMR-deficient endometrial cancer whose disease progresses on or following initial chemotherapy treatment.”
The companion diagnostic (CDx), which serves as a standardised testing option, uses a comprehensive panel of DNA mismatch repair (MMR) biomarkers tested by immunohistochemistry (IHC).
The VENTANA MMR RxDx Panel is a qualitative immunohistochemistry test designed for the evaluation of MMR proteins (MLH1, PMS2, MSH2 and MSH6) in formalin-fixed, paraffin-embedded (FFPE) endometrial carcinoma tissue by light microscopy.
The OptiView DAB IHC Detection Kit will be used for MLH1, MSH2 and MSH6, while the OptiView DAB IHC Detection Kit with the OptiView Amplification Kit will be used for PMS2 on a VENTANA BenchMark ULTRA instrument.
Last month, Roche secured FDA approval for its Ventana ALK (D5F3) CDx Assay as a companion diagnostic to identify people with a type of lung cancer.