New Molecular Test Approved to Detect HER2 in Women with Breast Cancer

August 2011, Vol 2, No 5 - FDA Approvals, News & Updates


A new test for detecting the HER2 gene in women with breast cancer has received FDA approval. The test, called Inform Dual ISH (Ventana Medical Systems), facilitates the use of standard microscopy to measure the number of copies of chromosome 17 and HER2 genes in a tumor sample on the same slide. Unlike traditional HER2 amplification, which uses fluorescence microscopy, the Inform Dual ISH test enables laboratory staff to view samples directly under a microscope, and for longer periods.

In a study involving tumor samples from 510 US patients with breast cancer, the test was effective in detecting an excessive number of copies of the HER2 gene in 96% of the HER2-positive tumor samples and a normal number of copies in 92.3% of HER2- negative samples. (June 14, 2011)