Ventana submits FDA filing for HER2 theranostic:
This article was originally published in Clinica
Ventana Medical Systems has filed for US approval of its novel theranostic for the breast cancer drug Herceptin (trastuzumab). The test, called the Inform HER2 SISH (silver in situ hybridisation) DNA probe assay, can identify patients suitable for Herceptin treatment in just six hours - half the time of current tests, which are based on FISH (fluorescence in situ hybridisation). The test identifies patients with amplified levels of the HER2 biomarker gene. The fully automated test will also be cheaper than standard tests, and allows the pathologist to archive slides, enabling the possibility of re-examination, claimed the Tucson, Arizona firm.