Part 6 of IVD Hall of Fame
« Lipid Profiling
Human epidermal growth factor receptor 2 (HER2/Neu) is a gene that sends control signals to cells, telling them to grow, divide, and make repairs. A healthy breast cell has 2 copies of the HER2 gene. If a breast cell has more than 2 copies of the HER2 gene, those copies start over-producing the HER2 protein. HER2/Neu assays either determine if more than the normal number of copies of the HER2 gene is present or test if there is over-expression of HER2 protein in breast cancer tissue.
An estimated 207,090 new cases of breast cancer were diagnosed in the United States during 2010 and about 39,840 women died from the disease, according to the National Cancer Institute. About 20 percent of women diagnosed with breast cancer are HER2-positive. Herceptin - a breast cancer therapy developed by Genentech Inc. - targets the HER2 protein production and helps to stop the growth of the HER2 positive cancer cells. Only patients with HER2 over-expression have shown benefit when treated with Herceptin.
In 1988, Dako received FDA approval for Hercep-Test, an immunohistochemistry assay used to identify patients with HER2-positive metastatic breast cancer. These HER2-positive patients were subsequently eligible for treatment with Herceptin. Prior to approval of Hercep-Test, Herceptin was not available as a treatment option for breast cancer patients. Dako’s Hercep-Test was also the first in vitro companion diagnostic device, and included information about the use of Herceptin in the device labeling. Both the diagnostic test and the therapeutic drug stipulate the use of the other.
The first FDA approved HER2/Neu test available was Ventana Medical Systems’ oncor inform her-2/neu gene detection system which was approved in 1997. The HER2/neu assays are also run to select breast cancer patients for treatment with Herceptin, but they have become an important tool in determining the prognosis for patients as well, since HER2 over-expression has been linked to some aggressive forms of breast cancer. The role of HER2/Neu tests in helping physicians select the best treatment options for breast cancer patients has made it a valuable tool in the fight against the disease.