Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Roche Diagnostics Australia Pty Limited
Class 3
Ventana Medical Systems Inc 1910 E Innovation Park Drive, Tucson, AZ, 85755 United States Of America
CT1056 - Immunohistology cell marker IVDs
Immunohistochemical staining of tissues for MMR status as an aid in identifying patients eligible for treatment with nominated therapies in selected indications VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody is intended for use in the assessment of mismatch repair (MMR) protein PMS2 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.