The companion diagnostic evaluates mismatch repair deficiency, a predictive biomarker used to identify patients who may respond to PD-1-targeted therapies.
Roche has received European Union In Vitro Diagnostic Regulation approval for several label expansions of its VENTANA MMR RxDx Panel. The immunohistochemistry companion diagnostic test identifies a cancer patient’s mismatch repair status, providing clinicians with information to guide treatment decisions across multiple solid tumor types.
Mismatch repair is a naturally occurring process that scans genetic code and fixes errors to prevent mutations that can lead to cancer. When this mechanism is deficient, cells mutate, which can result in tumor growth. The test evaluates a panel of mismatch repair proteins in tumors to identify patients who may be eligible for specific therapies, as mismatch repair deficiency serves as a predictive biomarker for modern immunotherapies.
“By providing a standardized testing option for mismatch repair status with our VENTANA MMR RxDx Panel, we are empowering clinicians to make more informed decisions and expanding access to important therapies for patients across multiple solid tumor types,” says Laura Apitz, head of pathology lab at Roche Diagnostics, in a release. “This milestone exemplifies our dedication to delivering high-medical-value solutions that help improve patient outcomes through precision medicine.”
The VENTANA MMR RxDx Panel is intended for the assessment of mismatch repair protein expression in formalin-fixed, paraffin-embedded (FFPE) tumor tissue. The testing process uses the OptiView DAB immunohistochemistry Detection Kit and specific reagents for anti-MLH1, anti-MSH2, anti-MSH6, and anti-PMS2 on a BenchMark ULTRA instrument.
According to Roche, mismatch repair deficiency is most common in endometrial cancer, but other high-prevalence tumor types include gastric, colorectal, small intestine, and biliary tract cancers. Because these tumors often have a high mutational burden, they may respond well to immune checkpoint inhibitors such as programmed death-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors.
Clinical evidence has proven that mismatch repair proteins are predictive biomarkers for PD-1 targeted therapy. Specifically, a loss of expression in one or more mismatch repair proteins might predict an increased likelihood of response to such treatments. The In Vitro Diagnostic Regulation approval represents a label expansion of the existing on-market panel from Roche.
The company notes that while cancer remains a leading cause of death worldwide, identifying specific biomarkers is critical for precision medicine. For patients with endometrial cancer without mismatch repair deficiency, the addition of other treatments like PARP inhibitors or tyrosine kinase inhibitors may be used in combination with immunotherapies to enhance clinical benefits.
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