Roche (RHHBY) has secured European Union In Vitro Diagnostic Regulation (IVDR) approval for expanded use of its VENTANA MMR RxDx Panel, a companion diagnostic designed to help identify cancer patients eligible for certain precision oncology therapies—a milestone the company says will broaden access to standardized mismatch repair (MMR) testing across multiple tumor types.
Roche announced that the updated approval covers five cancer types and six therapy indications, strengthening the panel's role as a predictive biomarker tool for modern immunotherapies.
The VENTANA MMR RxDx Panel is an immunohistochemistry (IHC) test that evaluates a set of MMR proteins in tumor samples to determine whether a patient's cancer is mismatch repair deficient (dMMR) or mismatch repair proficient (pMMR). This information helps clinicians identify patients who may benefit from targeted immunotherapies.
Laura Apitz, Head of Pathology Lab at Roche Diagnostics, said the approval "empowers clinicians to make more informed decisions" and reflects the company's commitment to delivering high-medical-value diagnostic solutions.
Expanded Indications Across Multiple Therapies
With IVDR approval, the panel is now authorized as a companion diagnostic for several leading oncology treatments, including:
-Merck's KEYTRUDA (pembrolizumab) for dMMR tumors in metastatic colorectal cancer, advanced or recurrent endometrial carcinoma, and unresectable or metastatic gastric, small intestine or biliary cancer.
- AstraZeneca's IMFINZI (durvalumab) for dMMR primary advanced or recurrent endometrial cancer.
- AstraZeneca's IMFINZI + LYNPARZA (olaparib) for pMMR primary advanced or recurrent endometrial cancer.
- GSK's JEMPERLI (dostarlimab-gxly) for dMMR endometrial cancer.
Why MMR Testing Matters
Mismatch repair is a natural process that scans DNA for errors and corrects them to prevent harmful mutations. When this system fails— resulting in dMMR—tumors may accumulate mutations that make them more responsive to certain immunotherapies.
Roche noted that identifying dMMR status is increasingly important as cancer remains the second leading cause of death worldwide, with nearly 10 million deaths annually.
A Step Forward for Precision Medicine
The company emphasized that the newly expanded label provides clinicians with a standardized, regulated testing option across multiple solid tumors, supporting more consistent treatment decisions and broader access to precision oncology.
RHHBY has traded between $37.51 and $60.85 over the past year. The stock closed Wednesday's trading at $50.23, down 0.63%.
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