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U.S. Department of Health and Human Services

Medical Devices

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DakoCytomation Her2 FISH pharmDx™ Kit - p040005

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 Her2 FISH pharmDx™ Kit
Applicant: DakoCytomation Denmark A/S
Address: Produktionsvej 42, DK-2600 Glostrup, Denmark
Approval Date: May 3, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040005a.pdf

What is it? The Her2 FISH pharmDx™ Kit is a kit used to identify breast cancer patients eligible for treatment with the cancer drug Herceptin® (Trastuzumab) and to determine the prognosis of a stage II, node-positive breast cancer patient.

This test is used by a doctor (pathologist) trained to identify diseases by studying slices of cells and tissues placed on microscope slides to analyze breast cancer tissue samples. The test detects an expansion of a gene in the body that regulates cancerous tissue cell growth (Her-2/neu). The presence of Her2/neu expansion indicates a patient is eligible for cancer treatment with the FDA approved drug Herceptin®.

How does it work? The Her2 FISH pharmDx™ Kit is a kit used to identify Her-2/neu in a tissue sample.

  • A small tissue sample containing cancer is cut from the patient’s breast cancer (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.
  • A patient tissue section on a microscope slide is treated with a specific fluorescence labeled DNA probe assay kit.
  • Fluorescence labeled DNA probes bound to the interphase nuclei of cells mark the candidate cells.
  • The labeled sample is placed under the microscope and examined by a medical professional who checks the quality of the fluorescence signals and records the results.
  • The results are reviewed by a pathologist.
  • The presence of Her2 /neu expansion indicates a patient is eligible for cancer treatment with Herceptin®

When is it used? The Her2 FISH pharmDx™ Kit is used in patients with breast cancer who are candidates for therapy with Herceptin®.

What will it accomplish? The Her2 FISH pharmDx™ Kit determines if a breast cancer patient is eligible for treatment with Herceptin®.

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.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p040005