For in vitro diagnostic use. Cytoplasm Membrane Others Anti-c-KIT 9.7 Primary Antibody IVD Breast GIST Skin PATHWAY® Anti-c-KIT (9.7) Primary Antibody RTD001083 Rabbit 9.7 05278317001 ASSY, Kit Pack, Pathway C-Kit PATHWAY Anti-c-KIT (9.7) Primary Antibody 04015630971916 Reagents, kits 790-2951 50 tests Not Available true This antibody is intended for in vitro diagnostic (IVD) use.Ventana® Medical Systems’ PATHWAY Anti-c-KIT (9.7) Primary Antibody is intended for laboratory use, via light microscopy, for the qualitative detection of KIT protein in formalin-fixed, paraffin-embedded gastrointestinal stromal tumors (GISTs) using either an automated immunohistochemistry staining system or a manual assay. It is indicated as an aid in the diagnosis of GIST within the context of the patient’s clinical history, tumor morphology, and other diagnostic tests evaluated by a qualified pathologist. It may be used after the diagnosis of GIST as an aid in the selection of GIST patients who may qualify for imatinib mesylate (Gleevec®/Glivec®) therapy.PATHWAY Anti-c-KIT (9.7) Primary Antibody is optimized for use on Ventana Automated Slide Stainer and for manual application in combination with Ventana Medical Systems’ iVIEW™ DAB Detection Kit and accessories. The clinical interpretation of any staining, or the absence of staining, must be complemented by morphological studies and evaluation of proper controls. Evaluation must be made by a qualified pathologist within the context of the patient’s clinical history and other diagnostic tests.Note:The test is not intended as the sole basis for making the diagnosis of GIST and is not intended as the sole basis for selecting Gleevec/Glivec therapy. The proportion of c-KIT negative GIST patients who can respond to Gleevec/Glivec has not been established. A negative result would not necessarily exclude the diagnosis of GIST, nor should it preclude treatment with Gleevec/Glivec (14, 34, 39).All of the subjects in the Novartis Gleevec/Glivec clinical trials were selected using an investigational immunocytochemical antibody (ICA). None of the subjects in those trials were selected using the Ventana PATHWAY Anti-c-KIT (9.7) Primary Antibody. The Ventana PATHWAY Anti-c-KIT (9.7) Primary Antibody was compared to the ICA on independent sets of samples and found to provide acceptably concordant results.13. Heinrich, M., Wait, C. L., Yee, K. W. H., and Griffith, D. J. STI571 inhbits the kinase activity of wild type and juxtamembrane c-KIT mutants but not the exon 17 D816V mutation associated with mastocytosis., Blood. 96: 173b (Abstr.), 200134. Taniguchi, M., Nishida, T., Hirota, S., Isozaki, K., Ito, T., Nomura, T., Matsuda, H., and Kitamura, Y. Effect of c-KIT mutation on prognosis of gastrointestinal stromal tumors, Cancer Res. 59: 4297-300, 1999.39. Medeiros, F., Corless, C.L., Duensing, A., Hornick, J.L., Oliveira, A.M., Heinrich, M.C., Fletcher, J.A., Fletcher, C.D. KIT-negative gastrointestinal stromal tumors: Proof of concept and therapeutic implications. Am J Surg Pathol. Jul 28(7): 889-894 2004 en PATHWAY Anti-c-KIT (9.7) Primary Antibody is a rabbit monoclonal antibody which binds a site on the internal domain of the KIT oncoprotein in paraffin-embedded tissue sections. The specific antibody is localized by a biotin-conjugated secondary antibody formulation that recognizes rabbit and mouse immunoglobulins. This step is followed by the addition of a streptavidin-enzyme conjugate that binds to the biotin present on the secondary antibody. The specific antibody-secondary antibody-streptavidin-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, sections are washed to stop the reaction and remove unbound material that would hinder the desired reaction in subsequent steps. Results are interpreted using a light microscope and aid in the differential diagnosis of pathophysiological processes, which may or may not be associated with a particular antigen.The use of Ventana Medical Systems' prediluted PATHWAY Anti-c-KIT (9.7) Primary Antibody and ready-to-use detection kits, in combination with a Ventana Automated Slide Stainer, reduces the possibility of human error and inherent variability resulting from individual reagent dilution, manual pipetting, and manual reagent application. For further information refer to the Ventana Automated Slide Stainer Operator's Manual.Histological tissue preparations have the advantage of intact tissue morphology to aid in the interpretation of the c-KIT positivity of the sample. All histological tests should be interpreted by a specialist in gastrointestinal tumor morphology, and/or pathology, and the results should be used in conjunction with other clinical and laboratory data. en