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.
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.