This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Ventana® Medical Systems' PATHWAY Anti-c-KIT (9.7) Primary Antibody
Applicant: Ventana® Medical Systems, Inc.
Address: 1910 Innovation Park Drive, Tucson, AZ 85705
Approval Date: August 11, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/p020055a.pdf
What is it? An antibody used in a lab test that can help identify patients with gastrointestinal stromal tumors (GISTs) and select patients eligible for treatment with the FDA approved cancer drug Gleevec®/ Glivec® (imatinib mesylate). The antibody is used with an automated tissue staining system or manual assays and specialized staining accessories.
The antibody is used by a doctor trained to identify diseases by studying cells and tissues (pathologist) to analyze tissue samples from patients suspected of having GISTs. The antibody detects a protein in the body that stimulates cancerous tissue cell growth (c-KIT tyrosine kinase). The presence of this protein indicates a diagnosis of cancer, in association with other clinical information, and indicates eligibility for GISTs cancer treatment with Gleevec®/Glivec®.
How does it work? The antibody is used to identify c-KIT in a tissue sample.
- A small tissue sample containing cancer is cut from the patient’s gastrointestinal system (biopsy).
- The tissue is embedded in a block of paraffin wax and a thin slice is cut from the block and attached to a glass slide.
- Anti-c-KIT antibodies are added to the sample and incubated.
- Additional chemicals are added to stain sites where anti-c-KIT antibodies have bound to the cancer.
- The sample is analyzed by a pathologist with a microscope.
When is it used? The antibody test is used in patients suspected of having gastrointestinal stromal tumors (GISTs) who could be candidates for selected drug therapy.
What will it accomplish? The antibody test aids in the diagnosis of GISTs and in determining patient eligibility for drug treatment with Gleevec®/Glivec®.
When should it not be used? None identified
Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p020055