For in vitro diagnostic use. Nucleus Others MSH2 G219-1129 MMR RxDx and MMR IHC Panel IVD Colorectal Cells VENTANA® anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody RTD001200 For use with VENTANA MMR RxDx Panel and the VENTANA MMR IHC Panel, US-FDA Mouse G219-1129 07 862 253 001 7 862 253 001 07862253001 7862253001 07862253001 MSH2 (G219-1129) Mouse Monoclonal PAB US VENTANA anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody 07613336100585 Reagents, kits 790-5093 50 tests Not Available true VENTANA MMR RxDx Panel VENTANA MMR RxDx Panel is a qualitative immunohistochemistry test intended for use in the assessment of mismatch repair (MMR) proteins (MLH1, PMS2, MSH2 and MSH6) in formalin-fixed, paraffin-embedded (FFPE) tissue specimens by light microscopy. The OptiView DAB IHC Detection Kit is used for MLH1, MSH2 and MSH6, and the OptiView DAB IHC Detection Kit with the OptiView Amplification Kit is used for PMS2 on a VENTANA BenchMark ULTRA instrument. VENTANA MMR RxDx 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, and VENTANA anti-MSH6 (SP93) Rabbit Monoclonal Primary Antibody. VENTANA MMR RxDx Panel is indicated as an aid in identifying patients eligible for treatment with the therapies listed in Table 1 for the indication and MMR status in accordance with the approved therapeutic product labeling. Table 1. VENTANA MMR RxDx Panel companion diagnostic indications. Indication for use Therapy MMR Status Solid Tumors JEMPERLI (dostarlimab-gxly) deficient MMR (dMMR) Solid Tumors KEYTRUDA (pembrolizumab) deficient MMR (dMMR) Endometrial Carcinoma (EC) KEYTRUDA (pembrolizumab) in combination with LENVIMA (lenvatinib) proficient MMR (pMMR) Endometrial Carcinoma (EC) IMFINZI (durvalumab) deficient MMR (dMMR) Results of the VENTANA MMR RxDx Panel should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This product is intended for in vitro diagnostic (IVD) use. VENTANA MMR IHC Panel 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 proteins 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 for use on the VENTANA BenchMark ULTRA instrument. 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 antiMSH6 (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. Intended for in vitro diagnostic (IVD) use. Prescription Use Only. en VENTANA MMR RxDx Panel VENTANA MMR RxDx Panel is a qualitative immunohistochemistry test intended for use in the assessment of mismatch repair (MMR) proteins (MLH1, PMS2, MSH2 and MSH6) in formalin-fixed, paraffin-embedded (FFPE) tissue specimens by light microscopy. OptiView DAB IHC Detection Kit is used for MLH1, MSH2 and MSH6, and OptiView DAB IHC Detection Kit with OptiView Amplification Kit is used for PMS2 on BenchMark ULTRA and BenchMark ULTRA PLUS instruments. VENTANA MMR RxDx 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, and VENTANA anti-MSH6 (SP93) Rabbit Monoclonal Primary Antibody. VENTANA MMR RxDx Panel is indicated as an aid in identifying patients eligible for treatment with the therapies listed in Table 1 for the indication and MMR status in accordance with the approved therapeutic product labeling. Table 1. VENTANA MMR RxDx Panel companion diagnostic indications. Indication for use Therapy MMR Status Solid Tumors KEYTRUDA (pembrolizumab) deficient MMR (dMMR) Endometrial Carcinoma (EC) KEYTRUDA (pembrolizumab) in combination with LENVIMA (lenvatinib) proficient MMR (pMMR) VENTANA MMR RxDx Panel results should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This product is intended for in vitro diagnostic (IVD) use. VENTANA MMR IHC Panel 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 proteins in formalin-fixed, paraffinembedded colorectal cancer (CRC) tissue sections. OptiView DAB IHC Detection Kit is used with MLH1, MSH2, MSH6 and BRAF V600E, and OptiView DAB IHC Detection Kit with OptiView Amplification Kit is used for PMS2 detection. VENTANA MMR IHC Panel is for use on VENTANA BenchMark ULTRA and BenchMark ULTRA PLUS instruments. VENTANA MMR IHC Panel includes VENTANA anti-MLH1 (M1) Mouse Monoclonal Primary Antibody, VENTANA antiPMS2 (A16-4) Mouse Monoclonal Primary Antibody, VENTANA antiMSH2 (G219-1129) Mouse Monoclonal Primary Antibody, VENTANA anti-MSH6 (SP93) Rabbit Monoclonal Primary Antibody, and VENTANA anti-BRAF V600E (VE1) Mouse Monoclonal Primary Antibody. 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. VENTANA MMR IHC Panel results should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. Intended for in vitro diagnostic (IVD) use. Prescription Use Only. en VENTANA anti-MSH2 (G219-1129) antibody is a mouse monoclonal antibody raised against a recombinant MSH2 protein. VENTANA anti-MSH2 (G219-1129) antibody binds to the MSH2 protein in 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). 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 or BenchMark ULTRA PLUS 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 to ULTRA LCS (Predilute), which minimizes evaporation of the aqueous reagents from the specimen slide. In addition to staining with VENTANA anti-MSH2 (G219-1129) antibody, a second slide should be stained with the mouse monoclonal negative reagent, Negative Control (Monoclonal) . The negative reagent control is used to assess background staining. en

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VENTANA^® anti-MSH2 (G219-1129) Mouse Monoclonal Primary Antibody

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