Product News: Dako Announces FDA Approval for Breast Cancer Companion Diagnostic Tests

15 Jun 2012

Dako, a world leading provider of cancer diagnostics solutions, 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 US 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, M.D., 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.

"Certainty goes to the very heart of Dako. We are therefore extremely pleased to make our high quality pharmDx products for Perjeta available to our US customers. Dako supports laboratories and doctors in the process of identifying HER2-positive breast cancer and this way we make vital treatment available to patients battling this aggressive disease," says Lars Holmkvist, CEO of Dako.

The FDA approval announced today is in line with Dako’s ongoing strategy to combine strengths with international pharmaceutical companies to grow the offering of Dako’s pharmDx™ assays.

Dako’s HercepTest™ and HER2 FISH pharmDx™ Kit as companion diagnostics for Perjeta™ is available now to customers in the United States.