MLH1 protein qualitative test reagent - Vietnam Registration 2401182ĐKLH/BYT-HTTB

VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody (VENTANA anti-MLH1 (M1)) is used in the laboratory to detect the protein MLH1 by immunohistochemistry in formalin-fixed, paraffin-embedded (FFPE) tissue sections using optical microscopy. VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody is ready-to-use on the BenchMark IHC/ISH with OptiView DAB Detection Kit and related accessories. VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody is a component of the VENTANA MMR RxDx Panel and VENTANA MMR IHC Panel, which are listed in Table 1. Table 1. Name of the Test and Clinical Application: - VENTANA MMR RxDx Panel (MLH1, PMS2, MSH2 and MSH6): The VENTANA MMR RxDx Panel is indicated to support the identification of patients with mismatch repair deficient (dMMR) endometrial carcinoma who are candidates for treatment with JEMPERLI (dostarlimab), as per the product label. - VENTANA MMR IHC Panel (MLH1, PMS2, MSH2, MSH6 and BRAF V600E): The VENTANA MMR IHC Panel is indicated for the detection of mismatch repair deficient (dMMR) protein, which is a test to identify individuals at risk for Lynch syndrome in patients diagnosed with colorectal cancer (CRC), and, in combination with the BRAF V600E status, supports differentiation between sporadic colorectal cancer and colorectal cancer that may be due to Lynch syndrome when no MLH1 protein expression is observed. The results of this test must be interpreted by a qualified pathologist in conjunction with histology, relevant clinical information, and appropriate control samples. This product is intended for in vitro diagnostic use (IVD).