FDA Approves Two Dako Assays as Companion Diagnostics for Genentech's New Breast Cancer Medicine Kadcyla

FDA Approves Two Dako Assays as Companion Diagnostics for Genentech's New 
Breast Cancer Medicine Kadcyla 
GLOSTRUP, DENMARK -- (Marketwire) -- 03/05/13 --  Dako, an Agilent
Technologies Company and worldwide provider of cancer diagnostics,
announced today it has received approval from the U.S. Food and Drug
Administration for the addition of Kadcyla in the labeling of two
Dako companion diagnostic assays.  
Kadcyla (ado-trastuzumab emtansine) is Genentech's new medicine for
patients with HER2-positive metastatic breast cancer who have
received prior treatment with Genentech's cancer medicine Herceptin
(trastuzumab) and a taxane chemotherapy. 
The two assays are Dako's HercepTest and HER2 IQFISH pharmDx. 
Today's announcement is the result of a collaboration between Dako
and Genentech, a member of the Roche Group. The collaboration was
initiated in early 2012, and later the same year Dako submitted
applications to the FDA requesting approval of the two Dako assays as
companion diagnostics for Genentech's drug candidate for patients
with HER2-positive metastatic breast cancer.  
Genentech's Kadcyla, an antibody-drug conjugate, and Dako's
HercepTest and HER2 IQFISH pharmDx have received simultaneous
approvals from the FDA.  
Dako's HercepTest and HER2 IQFISH pharmDx will serve as diagnostic
tools to identify cancer patients with HER2-positive metastatic
breast cancer who may be eligible for Kadcyla treatment. 
"At Dako, we focus on advancing cancer diagnostics, because patients'
lives depend on it," said Lars Holmkvist, CEO of Dako and senior vice
president, Agilent. "Partnering with companies who are also
relentless in their commitment to fighting cancer is an important
element in achieving this goal. Today's FDA approval is the result of
excellent collaboration between Dako and Genentech." 
Dako's ongoing strategy is to combine its strength in developing
companion diagnostics with its proven ability to partner with
pharmaceutical companies to increase the number of companion
diagnostic assays and ultimately improve personalized medicine. 
About Dako - An Agilent Technologies Company
 Dako, based in Denmark,
is a global leader in tissue-based cancer diagnostics. Hospital and
research laboratories worldwide use Dako's reagents, instruments,
software and expertise to make accurate diagnoses and determine the
most effective treatment for cancer patients. Dako, with 1,200
employees, operates in more than 100 countries. Dako became part of
Agilent Technologies on June 21, 2012. Information about Dako is
available at www.dako.com.  
About Agilent Technologies
 Agilent Technologies Inc. (NYSE: A) is
the world's premier measurement company and a technology leader in
chemical analysis, life sciences, diagnostics, electronics and
communications. The company's 20,500 employees serve customers in
more than 100 countries. Agilent had revenues of $6.9 billion in
fiscal 2012. Information about Agilent is available at
www.agilent.com. 
Editorial Contact
Maia Fredtoft Sochting
Corporate Communications
Dako Denmark A/S
Tel. +45 25 46 10 83 
 
 
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