Each year, Spectrum pathologists analyze over 110,000 body tissue and fluid specimens. In addition to surgical and clinical pathology, Spectrum pathologists have developed expertise in flow cytometry and molecular pathology, including FISH testing for the evaluation of HER-2/neu status in breast cancer patients.

HER-2/neu is a trans-membrane glycoprotein which is overexpressed in approximately 25% of breast cancer cases. The HER-2/neu gene (Human Epidermal Growth Factor Receptor 2) produces the HER-2/neu protein, which is expressed on the cell membrane of breast tissue cells and acts as a receptor for growth factors so that the cells divide and multiply. Breast cancer cells that overexpress the HER-2/neu protein, therefore, have an excessive number of growth factor receptors, resulting in rapid growth and multiplication of the tumor cells.

It is now considered the standard of care to complete a HER-2/neu assessment before selection of chemotherapy in breast cancer. HER-2/neu status is a strong, independent predictor of a patient's response to adriamycin-based therapy. HER2/neu expression may be also be used for prognostication, and to identify patients for possible Herceptin therapy. Herceptin is a humanized monoclonal antibody that binds to the Her2/neu membrane receptors, preventing the attachment of growth factors and slowing the abnormal growth of tumor cells.

Several tests are available for the assessment of HER-2/neu status, including immunohistochemistry (IHC) and fluorescent in-situ hybridization (FISH) technology. Spectrum Pathology uses IHC staining as the primary method for detection of the HER-2/neu protein in breast cancer cases. Our pathologists evaluate membranous HER-2/neu immuno-staining of the breast cancer cells and grade the staining as follows: negative (0-1+), weakly positive (2+), or strongly positive (3+). Cases that are interpreted as "weakly positive (2+)" by IHC are reflexed for FISH testing of HER-2/neu status, for a more definitive result. Direct FISH technology targets stable DNA at a molecular level, and is therefore a very sensitive method. Utilizing both methods of HER-2/neu detection provides very accurate results and allows referring physicians to provide the most effective therapy for their patients.

In September 2000, the US Food and Drug Administration approved the HER-2/neu test for prognostic use in metastatic breast cancer patients. In January 2002, Medicare and other payors began covering the test. The best technology for evaluating HER-2/neu status, together with Spectrum Pathology's clinical expertise, means that physicians can confidently develop treatment plans that will most benefit their patients with breast cancer. Our dedication to excellence assures patients and referring physicians that they will obtain rapid and accurate test results.