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Dako Receives FDA Approval for Fast, Accurate, Nontoxic FISH Assay for Cancer Diagnostics

Dako Receives FDA Approval for Fast, Accurate, Nontoxic FISH Assay for Cancer 
Diagnostics 
GLOSTRUP, DENMARK -- (Marketwire) -- 02/15/13 --  Dako, an Agilent
Technologies Company, today introduced IQISH technology in the United
States. The technology will reduce the turnaround time for cancer
evaluation from two days to three and a half hours. This will ease
the waiting time and associated anxiety for the patient and allow
physicians to more quickly initiate targeted cancer treatments. 
HER2 IQFISH pharmDx, a fluorescence in situ hybridization (FISH)
assay, is the first product approved by the U.S. Food and Drug
Administration that uses the Dako IQISH technology, which is based on
Dako's fast IQISH hybridization buffer chemistry.  
"Every second counts when waiting for test results that will indicate
how to treat your cancer most effectively," said Lars Holmkvist, CEO
of Dako and senior vice president, Agilent. "Dako is extremely proud
to get the FDA's approval to introduce this offering to our U.S.
customers." 
IQISH stands for "instant quality in situ hybridization," indicating
the significantly reduced turnaround time of patients' samples,
without compromising the quality of the result. 
"HER2 IQFISH pharmDx improves the workflow in the pathology
laboratory and is a valuable aid in assessing patients for whom
trastuzumab treatment is being considered," said Dr. David Hardisson,
University Hospital La Paz, School of Medicine, Autonomous University
of Madrid, IdiPAZ, Madrid, Spain. 
The HER2 IQFISH pharmDx assay can support laboratories in identifying
HER2 gene status with great accuracy-and now, speed. 
The HER2 gene encodes a protein called human epidermal growth factor
receptor 2 (HER2), which promotes the growth of cells. In about one
of every five breast cancers, the cancer cells make an excess of HER2
due to a HER2 gene mutation (amplification).  
HER2-positive breast cancers tend to be more aggressive than other
types of breast cancer. As they are also less responsive to hormone
treatment, medical treatments that specifically target HER2, for
example trastuzumab, are often considered.  
"The new protocol yields very distinct signals," said Professor
Giuseppe Viale, medical director at Istituto Europeo di Oncologia,
Milano, Italy. "With a protocol duration of only three and a half
hours, it will be much easier to plan laboratory time and handle
urgent cases."  
"HER2 IQFISH pharmDx will provide more timely results, allowing us to
incorporate FISH analysis into our routine workflow as easily as
immunohistochemistry," said Kenneth J. Bloom, MD, FCAP, chief medical
officer, Clarient Diagnostic Services Inc., a GE Healthcare company,
California, United States. 
IQFISH is also nontoxic, as it replaces a hazardous formamide buffer
with a safer ethylene carbonate, contributing to a healthier work
environment in the pathology lab. 
HER2 IQFISH pharmDx has been sold in Europe and countries working
with CE labeling, the mark of compliance with relevant European
regulations, since February 2012. HER2 IQFISH pharmDx is now
available in the U.S. 
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. 
Media Relations
Maia Fredtoft Sochting
Communications
Dako Denmark A/S
+45 25 46 10 83 
 
 
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