FDA Approves Dako A/S's HercepTest(TM) and HER2 FISH pharmDx(TM) Kit as Companion Diagnostics for Genentech's New Cancer Drug Perjeta(TM)
Published: Jun 12, 2012
GLOSTRUP, DENMARK--(Marketwire - June 11, 2012) - Dako, a world leading 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.
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™ will be available to customers in the United States as of today.
About pharmDx™ pharmDx™(pharmacoDiagnostic®) is Dako's trade name for a group of products which are used to select patients for a particular pharmaceutical treatment (companion diagnostics) or to monitor how well a specific treatment is working.
Dako, based in Denmark, is a global leader in tissue-based cancer diagnostics. Hospital and research laboratories worldwide use Dako's know-how, reagents, instruments and software to make precise diagnoses and determine the most effective treatment for patients suffering from cancer. Employing more than 1,000 people and operating in more than 100 countries, Dako covers essentially all of the global anatomic pathology markets. On May 16, 2012, Agilent Technologies, Inc. entered into an agreement with EQT - a Swedish-based private equity group - to acquire Dako. The acquisition is expected to be completed within 60 days of signing. For more information please visit www.dako.com
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Source: Dako Denmark A/S via Thomson Reuters ONE
Maia Fredtoft Sochting
Dako Denmark A/S
Tel. +45 25 46 10 83