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™
HER2 FISH pharmDx™ Kit as companion diagnostics for pertuzumab
- a new Genentech cancer drug.
Today's announcement is the result of the collaboration between Genentech
Dako on a parallel US FDA approval process of Genentech's cancer drug and
The Genentech cancer drug (pertuzumab) - which has also received
from FDA - will be marketed under the name Perjeta™.
"The role of HER2 in diagnosis and clinical decision making continues to
with the recent approval of Perjeta, a new targeted biologic therapy for
patients with advanced HER2-positive breast cancer. It is clear that
patient care depends now more than ever on the accurate, reliable, and
reproducible assessment of the HER2 status for the full benefit of Perjeta
derived by the appropriate patient population," says David Hicks, M.D.,
of Surgical Pathology, University of Rochester Medical Center, New York.
Dako's HercepTest™ and HER2 FISH pharmDx™ Kit will serve as
tools to identify cancer patients with HER2-positive metastatic breast
who may be eligible for Perjeta™ treatment.
"Certainty goes to the very heart of Dako. We are therefore extremely
make our high quality pharmDx products for Perjeta available to our US
customers. Dako supports laboratories and doctors in the process of
HER2-positive breast cancer and this way we make vital treatment available
patients battling this aggressive disease," says Lars Holmkvist, CEO of
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
Perjeta™ will be available to customers in the United States as of
pharmDx™(pharmacoDiagnostic®) is Dako's trade name for a group of
which are used to select patients for a particular pharmaceutical treatment
(companion diagnostics) or to monitor how well a specific treatment is
Dako, based in Denmark, is a global leader in tissue-based cancer
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
all of the global anatomic pathology markets. On May 16, 2012, Agilent
Technologies, Inc. entered into an agreement with EQT - a Swedish-based
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