The FDA has approved Inform Dual ISH from Ventana Medical Systems, a genetic test to help determine if women with breast cancer are HER2-positive and therefore candidates to receive Herceptin (trastuzumab; Genentech), a HER2 inhibitor. The HER2 gene is located on chromosome 17 in human cells. The Inform Dual ISH test stains the HER2 gene black and the chromosome 17 gene red to allow for measurement of the number of copies of the HER2 gene in tumor tissues. Additionally, the Inform DUAL ISH allows the sample to be viewed directly under a microscope for longer periods of time.
This approval was based on data from a study involving 510 patients with breast cancer that showed that Inform Dual ISH was effective in confirming that a patient’s tumor sample contained more than the normal number of copies of the HER2 gene in 96% of the HER2 positive tumor samples. Patients with more than the normal number of copies of the HER2 gene are considered candidates for Herceptin therapy. The study also showed that the test was effective at excluding the possibility that more than the normal number of copies of the HER2 gene were present in 92.3% of the HER2 negative tumor samples. Patients who do not have more than the normal number of copies of the HER2 gene are typically not candidates for Herceptin therapy.
For more information visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm259055.htm.