Breaking News

French Planes Carry Out First Strikes on Iraq Islamic State Targets
Tweet TWEET

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 ac
curate
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. 
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants
that: 


 
(i) the releases contained herein are protected by copyright and
    other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
     originality of the information contained therein.

 
Source: Dako Denmark A/S via Thomson Reuters ONE [HUG#1683056] 
Editorial Contact
Maia Fredtoft Sochting
Corporate Communications
Dako Denmark A/S
Tel. +45 25 46 10 83
 
 
Press spacebar to pause and continue. Press esc to stop.