Roche announces that its VENTANA MMR RxDx Panel, a companion diagnostic for precision oncology, has received approval under the EU In Vitro Diagnostic Regulation (IVDR) for use across multiple cancer types and therapies. The test is designed to act as a predictive biomarker by evaluating a panel of mismatch repair (MMR) proteins in tumour samples. According to the company, the results help identify which patients are eligible for treatment with certain precision oncology therapies. Roche states that the panel is intended to provide clinicians with a standardized testing option, using the assessment of MMR protein status to support treatment selection. The announcement comes through PR Newswire, and the reported details focus on the scope of IVDR approval and the diagnostic’s role in matching patients to therapies based on tumour biomarker evaluation. The sources do not provide additional figures on the number of cancer types, specific therapies included, or clinical performance metrics. All available information centers on regulatory approval and the intended clinical use of the companion diagnostic.
Roche’s VENTANA MMR RxDx Panel gets IVDR approval for multiple cancer types
Roche announces that its VENTANA MMR RxDx Panel, a companion diagnostic for precision oncology, has received approval under the EU In Vitro Diagnostic Regulation (IVDR) for use across multiple cancer...
- Roche’s VENTANA MMR RxDx Panel receives approval under the EU IVDR.
- The panel is used as a predictive biomarker for treatment eligibility.
- It evaluates a panel of mismatch repair (MMR) proteins in tumour samples.
- The approval covers multiple cancer types and therapies.
- The test is described as providing a standardized option for clinicians.
Used as a predictive biomarker, the first-of-its-kind VENTANA MMR RxDx Panel helps identify cancer patients eligible for treatment with certain precision oncology therapies By evaluating a panel of MMR proteins in tumours, the test provides clinicians with a standardised testing option to...
19 hours agoUsed as a predictive biomarker, the first-of-its-kind VENTANA MMR RxDx Panel helps identify cancer patients eligible for treatment with certain precision oncology therapies By evaluating a panel of MMR proteins in tumours, the test provides clinicians with a standardised testing option to...
19 hours ago
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