New Breast Cancer HER2 Diagnostic Tests Approved by FDA

June 12, 2012 — Two diagnostic tests to identify HER2-positive breast cancer have been approved by the US Food and Drug Administration (FDA) for use as companion diagnostics for the new targeted therapy Pertuzumab [Perjeta].

The tests — HercepTest and HER2 FISH pharmDx Kit — are both manufactured by Dako in Glostrup, Denmark. The tests serve as diagnostic tools to identify patients with HER2-positive metastatic breast cancer who might be eligible for treatment with HER2-positive targeted therapies. The latest of these —Pertuzumab [Perjeta]— was approved  just days ago by the American Food and Drug Administration (FDA) for use in combination with Trastuzumab [Herceptin] and chemotherapy in patients with HER2-positivemetastatic breast cancer who have not been treated with either trastuzumab or chemotherapy.

“The role of HER2 in diagnosis and clinical decision making continues to evolve with the recent approval of Pertuzumab [Perjeta]”, said David Hicks, MD, director of surgical pathology at the University of Rochester Medical Center in New York. “It is clear that optimal patient care depends now more than ever on the accurate, reliable, and reproducible assessment of HER2 status for the full benefit of pertuzumab to be derived by the appropriate patient population,” he noted in a Dako press release. Dako reported that it had been collaborating with Genentech on a parallel FDA approval process for the 2 tests and the new drug.