Device Dossier
VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody - Immunohistology cell marker IVDs
Device Dossier for VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody - Immunohistology cell marker IVDs (CT1056 - Immunohistology cell marker…
- GMDN category: CT1056 - Immunohistology cell marker IVDs
Intended purpose
VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody is intended for use in the assessment of mismatch repair (MMR) protein MLH1 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 as an aid in identifying patients eligible for treatment with nominated therapies in selected indications