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

Tue Mar 5, 2013 9:00am EST

* Reuters is not responsible for the content in this press release.

  GLOSTRUP, DENMARK, Mar 05 (Marketwire) -- 
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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