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.
About Dako
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
[HUG#1618928]
