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New Device Approval

DakoCytomation c-Kit pharmDx™ - P040011

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: DakoCytomation’s c-Kit (9.7) pharmDx™
Applicant: DakoCytomation, Inc.
Address: 6392 Via Real, Carpinteria, CA 93013
Approval Date: June 27, 2005
Approval Letter: http://www.fda.gov/cdrh/pdf4/P040011a.pdf

What is it? DakoCytomation’s c-Kit (9.7) pharmDx is used to aid identification of patients with gastrointestinal stromal tumors (GIST) and selection of patients eligible for treatment with the cancer drug Gleevec® (imatinib mesylate). It is used with an automated tissue staining system or manual assays and specialized staining accessories.

This assay is used by a doctor (pathologist) trained to identify diseases by studying cells and tissues to analyze tissue samples from patients suspected of having GIST. The antibody detects a protein in the body that stimulates cancerous tissue cell growth (c-KIT tyrosine kinase). The presence of this protein in association with other pathological and clinical information establishes a diagnosis of GIST and indicates eligibility for treatment of GIST with the FDA-approved drug, Gleevec®.

How does it work? The antibody is used to identify c-KIT protein 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 that 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 who are suspected of having gastrointestinal stromal tumor (GIST) and could be candidates for selected drug therapy.

What will it accomplish? Aid in the diagnosis and determine eligibility for drug treatment with Gleevec®.

When should it not be used? There are no contraindications for the use of this device.

Additional information:
Summary of Safety and Effectiveness and labeling will be available at:
http://www.fda.gov/cdrh/pdf4/P040011b.pdf

Other:
American Cancer Society
http://www.cancer.org/docroot/home/index.asp

Updated September 28, 2005

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