Herceptin Approval + HER2 ISH Assay

Disease: HER2+ Metastatic Breast Cancer

About the Disease: 25-30 percent of women with metastatic breast cancer have a genetic alteration in the HER2 (human epidermal growth factor receptor 2) gene, which produces an increased amount of the growth factor receptor protein on the tumor cell surface.

What makes it unique:

Before Herceptin, there were no targeted treatments for solid cancer tumors that were paired with a companion diagnostic test and it marked Genentech’s first personalized treatment. When Herceptin was introduced, it fundamentally changed the way cancer treatment was contemplated, as doctors first had to test their patient’s tumor to see if it was Her2-positive.

Companion Diagnostic: HER2 ISH Assay