Dako, a Danish provider of cancer diagnostics solutions, has received approval from the US Food and Drug Administration to market HercepTest and HER2 FISH pharmDx Kit as companion diagnostics for pertuzumab (Perjeta) - a new Genentech cancer drug.
Dako said the FDA clearance is in line with its ongoing strategy to combine strengths with international pharmaceutical companies to grow the offering of the company’s pharmDx assays.
Dako and Genentech has also collaborated on a parallel US FDA approval process of the latter’s cancer drug and former’s pharmDx assays.
Dako will market the Genentech cancer drug (pertuzumab), which has also received authorization from FDA, under the name Perjeta.
University of Rochester Medical Center, New York director of Surgical Pathology David Hicks said 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," Hicks said.
Dako’s HercepTest and HER2 FISH pharmDx Kit will be utilized as diagnostic tools to identify cancer patients with HER2-positive metastatic breast cancer who may be eligible for Perjeta treatment.
Dako CEO Lars Holmkvist said, "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."