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U.S. Department of Health and Human Services

Medical Devices

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Invitrogen SPOT-Light® HER2 CISH™ Kit - P050040

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: SPOT-Light® HER2 CISH™ Kit
PMA Applicant: Invitrogen Corporation
Address: 1600 Faraday Ave, Carlsbad, CA 92008
Approval Date: Jult 1, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf5/p050040a.pdf

What is it? The SPOT-Light ® HER2 CISH ™ kit is a laboratory test that uses DNA probes to measure the number of copies of Her-2 gene on chromosome 17 in breast cancer cells by a chromogenic method. Increased number of copies of Her-2 gene indicates the breast cancer patient is eligible for treatment with the cancer drug Herceptin® (Trastuzumab).

How does it work?

  • A small sample is obtained from the patient’s breast cancer (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, a digoxigenin-tagged DNA probe binds to matching DNA of the Her-2 gene on the slide.
  • The presence of these DNA probes is detected with a fluorescent (FITC) tagged antibody to digoxigenin followed by a horseradish peroxidase conjugated antibody to FITC and DAB.
  • A trained medical professional uses a microscope to check the quality of the Her-2 gene signals and counts the number of Her-2 signals.
  • Results are reviewed by a doctor trained to interpret lab test results (a pathologist) and reported to the ordering doctor.

When is it used? Breast cancer patients for whom menopausal status and tumor characteristics suggest they might be candidates for Herceptin® therapy.

What will it accomplish? The SPOT-Light® HER2 CISH™ Kit, when used with other clinical information and laboratory tests, helps to determine if a breast cancer patient is eligible for Herceptin® treatment.

When should it not be used? This test should not be used for patients who have not been diagnosed with breast cancer, or whose menopausal status and breast tumor characteristics do not match the requirements for Herceptin® treatment.

Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p050040