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U.S. Department of Health and Human Services

Medical Devices

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BOND™ ORACLE™ Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemical (IHC) System - P090015

 

Sample items of cancer test pieces and test unit

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: BOND™ ORACLE™Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemical (IHC) System
PMA Applicant: Leica Biosystems, Ltd.
Address:
Balliol Business Park West
Benton Lane
Newcastle-Upon-Tyne NE128EW
United Kingdom
Approval Date: April 18, 2012
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf9/p090015a.pdf

What is it? The BOND™ ORACLE™ Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemical (IHC) System is a laboratory test that measures how much HER2 protein is being made by breast cancer cells. The test uses a technique 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, then a breast 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 breast 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 the HER2 protein binds to the HER2 protein molecules on the breast cancer sample on the slide.
  • A second antibody that has a special chemical attached to it binds to the HER2 antibody.
  • Developing chemicals react with the special chemical on the slide that causes 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 disclaimer icon ) 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 breast cancer patients whose tumor characteristics suggest that they might be candidates for Herceptin® therapy.

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

What will it accomplish? The BOND™ ORACLE™ Human Epidermal Growth Factor Receptor 2 (HER2) Immunohistochemical (IHC) System, when used with other clinical information and laboratory tests, helps to determine if a patient with breast cancer is eligible for Herceptin® treatment which may prolong their life.

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

Other Resources: