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

2013-03-05 15:05:12 -
GLOSTRUP, Denmark, March 5, 2013 - 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 Søchting
Corporate Communications
Dako Denmark A/S
Tel. +45 25 46 10 83




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Source: Dako Denmark A/S via Thomson Reuters ONE
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