Device Dossier

VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody - Immunohistology cell marker IVDs

Device Dossier for VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody - Immunohistology cell marker IVDs (CT1056 - Immunohistology cell…

Intended purpose

VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody is intended for use in the assessment of mismatch repair (MMR) protein MSH2 in formalin-fixed, paraffin-embedded tissue specimens stained on a VENTANA BenchMark ULTRA and BenchMark ULTRA PLUS instrument. This antibody is one of the components of VENTANA MMR RxDx Panel that is indicated as an aid in identifying patients eligible for treatment with pembrolizumab in deficient MMR solid tumours, and a combination of pembrolizumab and lenvatinib in proficient MMR endometrial carcinoma.

Functional description

Immunohistochemical staining of tissues for MMR status asan aid in identifying patients eligible for treatment withnominated therapies in selected indications

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