Dako has received approval from the US Food and Drug Administration (FDA) to market HercepTest and HER2 FISH pharmDx Kit as companion diagnostics for pertuzumab (Perjeta), a new Genentech cancer drug.
Today’s announcement is the result of the collaboration between Genentech and Dako on a parallel FDA approval process of Genentech’s cancer drug and Dako’s pharmDx assays.
The Genentech cancer drug (pertuzumab)—which has also received authorization from FDA—will be marketed under the name Perjeta.
“The role of HER2 in diagnosis and clinical decision making continues to evolve with the recent approval of Perjeta, a new targeted biologic therapy for patients with advanced HER2-positive breast cancer. It is clear that optimal patient care depends now more than ever on the accurate, reliable, and reproducible assessment of the HER2 status for the full benefit of Perjeta to be derived by the appropriate patient population,” says David Hicks, MD, director of surgical pathology, University of Rochester Medical Center, New York.
Dako’s HercepTest and HER2 FISH pharmDx Kit will serve as diagnostic tools to identify cancer patients with HER2-positive metastatic breast cancer who may be eligible for Perjeta treatment.