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New Device Approval

DakoCytomation EGFR pharmDx™ - P030044

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 EGFR pharmDx™
Applicant: DakoCytomation California, Inc
Address: 6392 Via Real. Carpinteria, California 93013
Approval Date: February 12, 2004
Approval Letter: http://www.fda.gov/cdrh/pdf3/p030044a.pdf

What is it? DakoCytomation EGFR pharmDx™ is used to identify colorectal cancer patients eligible for treatment with the cancer drug, ERBITUX™ (cetuximab).

The EGFR pharmDx™ is a kit used by a doctor trained to identify diseases by studying cells and tissues (pathologist) to analyze a colon tissue sample. The kit detects a protein in the body that stimulates cancerous tissue cell growth (Epidermal Growth Factor Receptor or EGFR). The presence of this protein indicates a patient is eligible for colon cancer treatment with ERBITUX™.

How does it work? The EGFR pharmDx™ is a kit used to identify EGFR in a tissue sample.

• A small tissue sample containing cancer is cut from the patient’s colon (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-EGFR antibodies are added to the sample and incubated.
• The EGFR pharmDx™ kit adds chemicals that stain sites where anti-EGFR antibodies have bound to the cancer.
• The sample is analyzed by a pathologist with a microscope.
• The presence of these reactions indicates a patient is eligible for cancer treatment with ERBITUX™.

When is it used? The DakoCytomation EGFR pharmDx™ kit is used in patients with colorectal cancer.

What will it accomplish? The DakoCytomation EGFR pharmDx™ kit determines if a patient is eligible for treatment with ERBITUX™.

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

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf3/p030044.html

Other:

An overview of the diagnosis and treatment of colon cancer from the American Cancer Society:
http://www.cancer.org/docroot/CRI/CRI_2_1x.asp?dt=10

The Colon Cancer Alliance, support and information for people affected by colorectal cancer:
http://www.ccalliance.org/

Information on treatment options and the stages of colon cancer from the National Cancer Institute:
http://www.nci.nih.gov/cancerinfo/pdq/treatment/colon/patient/

Updated March 16, 2004

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