For in vitro diagnostic use. Cytoplasm Others BRAF V600E VE1 US VENTANA IVD Colorectal Cells VENTANA® anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody RTD001190 For use with VENTANA MMR IHC Panel, US-FDA Mouse VE1 07862270001 BRAF V600E (VE1) Mouse Monoclonal PAB US VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody 07613336100608 Reagents, kits 790-5095 50 tests Not Available true The VENTANA MMR IHC Panel is a qualitative immunohistochemistry (IHC) test intended for use in the light microscopic assessment of mismatch repair (MMR) proteins (MLH1, PMS2, MSH2, and MSH6) and BRAF V600E protein in formalin-fixed, paraffinembedded colorectal cancer (CRC) tissue sections. The OptiView DAB IHC Detection Kit is used with MLH1, MSH2, MSH6 and BRAF V600E, and the OptiView DAB IHC Detection Kit with OptiView Amplification Kit is used for PMS2 detection. The VENTANA MMR IHC Panel is intended for use on the BenchMark ULTRA and BenchMark ULTRA PLUS instruments. The VENTANA MMR IHC Panel includes VENTANA anti- MLH1 (M1) Mouse Monoclonal Primary Antibody, VENTANA anti-PMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP93) Rabbit Monoclonal Primary Antibody, and VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody.The VENTANA MMR IHC Panel is indicated in patients diagnosed with colorectal cancer (CRC) to detect mismatch repair (MMR) proteins deficiency as an aid in the identification of probable Lynch syndrome and to detect BRAF V600E protein as an aid to differentiate between sporadic CRC and probable Lynch syndrome.Results from the VENTANA MMR IHC Panel should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.The clinical performance of this device to guide treatment of MMR deficient patients has not been established.Intended for in vitro diagnostic (IVD) use. Prescription Use Only. en The BRAF gene located on chromosome 7q34 encodes a cytoplasmic serine-threonine kinase that acts downstream of the mitogen-activated protein kinase (MAPK) signaling pathway. Oncogenic mutations in the BRAF gene, all within the kinase domain, constitutively activate the MAPK signaling pathway resulting in increased cell proliferation and apoptosis resistance. The most common of all activating BRAF mutations (T1799A point mutation) results in a substitution of valine (V) to glutamic acid (E) at position 600 of the amino acid sequence.30 The BRAF V600E mutation was detected in approximately 8% of all solid tumors, including 43% of melanomas, 39% of papillary thyroid carcinomas, 12% of serous ovarian carcinomas, 12% of colorectal adenocarcinomas, 2% of lung cancers, and in other cancers.31 Furthermore, the BRAF V600E mutation has been recently described as a molecular marker of hairy cell leukemia.32The VENTANA anti-BRAF V600E (VE1) antibody is a mouse monoclonal antibody (clone VE1) produced against a synthetic peptide representing the BRAF mutated amino acid sequence from amino acid 596 to 606 (GLATEKSRWSG). This mutation-specific antibody exhibits a cytoplasmic staining pattern. This antibody differentiates the V600E mutation in the BRAF protein from the wild type BRAF protein and other mutated BRAF proteins.33, 34In the context of mismatch repair (MMR) IHC testing for potential Lynch syndrome, the identification of the BRAF V600E mutation in MLH1 loss cases is indicative of sporadic colorectal cancer (CRC).29VENTANA anti-BRAF V600E (VE1) antibody binds specifically to the BRAF V600E mutant protein in formalin-fixed, paraffin-embedded (FFPE) tissue sections. The antibody can be localized using a haptenated secondary antibody followed by a multimer anti-hapten-HRP conjugate (OptiView DAB IHC Detection Kit, Cat. No. 760-700 / 06396500001). The specific antibody-enzyme complex is then visualized with a precipitating enzyme reaction product. Each step is incubated for a precise time and temperature. At the end of each incubation step, the BenchMark ULTRA instrument washes the sections to stop the reaction and to remove unbound material that would hinder the desired reaction in subsequent steps. It also applies ULTRA LCS (ULTRA LCS (Predilute), Cat. No. 650-210 / 05424534001), which minimizes evaporation of the aqueous reagents from the specimen slide.In addition to staining with VENTANA anti-BRAF V600E (VE1) antibody, a second slide should be stained with a mouse monoclonal negative reagent, such as Negative Control (Monoclonal) (Cat. No. 760-2014 / 05266670001). The negative reagent control is used to assess background staining.29. Koinuma K, Shitoh K, Miyakura Y, Furukawa T, Yamashita Y, et al. Mutations of BRAF are associated with extensive hMLH1 promoter methylation in sporadic colorectal carcinomas. Int J Cancer. 2004;108(2):237-242.30. Davies H, Bignell GR, Cox C, Stephens P, Edkins S, et al. Mutations of the BRAF gene in human cancer. Nature. 2002;417(6892):949-954.31. Vakiani E, Solit DB. KRAS and BRAF: drug targets and predictive biomarkers. J Pathol. 2011;223(2):219-229.32. Tiacci E, Schiavoni G, Forconi F, Santi A, Trentin L, et al. Simple genetic diagnosis of hairy cell leukemia by sensitive detection of the BRAF-V600E mutation. Blood. 2012;119(1):192-195.33. Capper D, Preusser M, Habel A, Sahm F, Ackermann U, et al. Assessment of BRAF V600E mutation status by immunohistochemistry with a mutation-specific monoclonal antibody. Acta Neuropathol. 2011;122(1):11-19.34. Capper D, Berghoff AS, Magerle M, Ilhan A, Wohrer A, et al. Immunohistochemical testing of BRAF V600E status in 1,120 tumor tissue samples of patients with brain metastases. Acta Neuropathol. 2012;123(2):223-233. en