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U.S. Department of Health and Human Services

Medical Devices

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InSite™ Her-2/neu kit - P040030

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: BioGenex InSite™ Her-2/neu Mouse Monoclonal Antibody (Clone CB11) kit
Applicant: BioGenex Laboratories, Inc.
Address: 4600 Norris Canyon Road, San Ramon, CA 94583
Approval Date: December 22, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/p040030a.pdf

What is it? The InSite™ Her-2/neu is a kit used to identify breast cancer patients eligible for treatment with the cancer drug Herceptin® (Trastuzumab). It is used with an automated tissue staining system or manual assays and specialized staining accessories.

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

How does it work? The InSite™ Her-2/neu 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.
  • Anti-Her-2/neu antibodies are added to the sample and incubated.
  • The InSite™ Her-2/neu kit adds chemicals that stain sites where anti- Her-2/neu 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 Herceptin®

When is it used? The InSite™ Her-2/neu kit is used in patients with breast cancer that are candidates for therapy with Herceptin®.

What will it accomplish? The InSite™ Her-2/neu 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=p040030