Herceptin is marketed by Roche in San Francisco, formerly known as Genentech and Ventana is also a Roche company who will be creating the test. The test works by confirming that a patient's tumor sample contains more than the normal number of copies of the HER2 gene. Patients who do not have more than the normal amount are not good candidates for Herceptin treatments. Also on the topic of breast cancer the FDA hearing requested by Roche is due to be heard on the topic of using Avastin for metastatic breast cancer. BD
SILVER SPRING, Md., June 14, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved a new genetic test that will help health care professionals determine if women with breast cancer are HER2-positive and, therefore, candidates for Herceptin (trastuzumab), a commonly used breast cancer treatment.
The test, called Inform Dual ISH, allows for measurement of the number of copies of the HER2 gene in tumor tissue. The HER2 gene is located on chromosome 17 in human cells. An excessive amount of the protein produced by the gene is found in some types of cancer cells, including breast cancer cells.
The Inform Dual ISH test allows lab personnel to count the number of copies of HER2 genes on chromosome 17 in a small sample of the breast tumor. The sample is stained with chemicals that cause copies of HER2 genes and chromosome 17 to change color. Copies of the HER2 gene appear black and copies of chromosome 17 appear red. These color changes can be seen under a standard microscope.