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U.S. Department of Health and Human Services

Medical Devices

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Dako HercepTest™ - P980018/S010

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 Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: HercepTest™
PMA Applicant:
Dako Denmark A/S
Address:
Produktionsvej 42, DK-2600 Glostrup, Denmark
Approval Date:
October 20, 2010
Approval Letter: 
http://www.accessdata.fda.gov/cdrh_docs/pdf/p980018s010a.pdf

What is it? HercepTest™ is a laboratory test that measures how much Her2 protein is being made by the cancer cells. This test has been used in patients with breast cancer and now can be used in patients with spreading (metastatic) stomach (gastric) cancer. The test uses a technique (immunohistochemistry) that will specifically recognize the Her2 protein in a tissue sample. If the test result indicates that too much Her2 protein is on the cancer cell surface ( overexpression), then a gastric cancer patient may be eligible for treatment with the cancer drug Herceptin® (Trastuzumab) .

How does it work?

  • The doctor removes a small sample from the patient’s stomach cancer and examines it (biopsy).
  • The sample is embedded in paraffin wax and a thin slice is cut and attached to a glass microscope slide.
  • With special chemicals and heat treatment, an antibody that specifically recognizes Her2 protein binds to the Her2 protein molecules on the stomach cancer sample on the slide.
  • A second antibody that has a special chemical attached, binds to the Her2 antibody.
  • Developing chemicals react with the special chemical on the slide and cause a brown dye to show where the Her2 protein is in the cancer tissue sample.
  • The slide is then stained with a blue dye so the doctor can see the other tissues.
  • A doctor (pathologist) that is trained to read the slides uses a microscope to check the quality, interprets the staining pattern, and reports the results to the ordering doctor.

When is it used? For gastric cancer patients whose tumor characteristics suggest that they might be candidates for Herceptin® therapy .

What will it accomplish? The Dako HercepTest™, when used with other clinical information and laboratory tests, helps to determine if a patient with gastric cancer is eligible for Herceptin® treatment which may prolong their life.

When should it not be used? When gastric cancer patients whose tumor characteristics suggest that they are not candidates for Herceptin® therapy .

Additional information : Summary of Safety and Effectiveness and labeling are available online. 

Other Resources: