Dako Denmark A/S : Dako Receives FDA Approval for Fast, Accurate, Nontoxic
FISH Assay for Cancer Diagnostics
GLOSTRUP, Denmark, Feb. 15, 2013 - 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
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
"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
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
"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
IQFISH is also nontoxic, as it replaces a hazardous formamide buffer with a
safer ethylene carbonate, contributing to a healthier work environment in the
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.
Maia Fredtoft Søchting
Dako Denmark A/S
+45 25 46 10 83
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Source: Dako Denmark A/S via Thomson Reuters ONE
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