Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
Become a Member | Sign in
Home>News>This Article

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

Published: Monday, February 18, 2013
Last Updated: Monday, February 18, 2013
Bookmark and Share
Dako, an Agilent Technologies Company, has 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.

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,600+ scientific posters on ePosters
  • More than 3,800+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Agilent Technologies Launches New Products for Analyzing Biotherapeutics
Expanded AdvanceBio portfolio enables scientists to speed research and lower costs.
Thursday, June 25, 2015
Agilent Announces New CEO Mike McMullen
McMullen elected as chief executive officer by Company’s board of directors.
Thursday, March 19, 2015
Agilent’s Microarray Scanner Approved for In Vitro Diagnostics in China
Regulators approve SureScan Dx as medical device.
Wednesday, January 28, 2015
Dako, Cell Signalling Tech Partner with Companion Diagnostics
Partnership for development of high-quality, cutting-edge companion diagnostic products for diagnosis and treatment of cancer.
Monday, January 12, 2015
Agilent Announces Global Distribution Agreement with Cartagenia for CNV Analysis
To assist cytogenetic labs in the clinical interpretation of microarray data.
Friday, May 30, 2014
Agilent Appoints Senior VP and President of Life Sciences and Diagnostics Group
Fred Strohmeier, has been named senior vice president, Agilent, and president of Agilent's Life Sciences and Diagnostics Group (LDG), effective immediately.
Wednesday, December 18, 2013
Dako Publishes Sixth Edition of Immunohistochemistry Guidebook
Reference book used by pathology laboratories worldwide.
Monday, December 16, 2013
Agilent Reports Fourth-Quarter Results
Agilent Technologies reported orders up 4 percent over one year ago to $1.83 billion with revenues of $1.72 billion, down 3 percent compared with one year ago.
Monday, November 18, 2013
Agilent Technologies to Separate into Two Public Companies
Life sciences, diagnostics and applied markets (LDA) that will retain the Agilent name, and the other company will be comprised of Agilent's electronic measurement (EM) products.
Monday, September 23, 2013
Agilent Technologies Announces Winner of Fifth Annual Early Career Professor Award
Assistant Professor at Northwestern Recognized for Cancer Diagnostics Research.
Friday, May 10, 2013
Dako to Offer New Antibody in U.S. to Diagnose Breast Cancer
Dako receives clearance to sell FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1 in US.
Monday, April 08, 2013
Dako to Collaborate with Pfizer
Collaboration agreement in the field of companion diagnostics.
Monday, February 18, 2013
Agilent Technologies Microarrays Used in Groundbreaking Prenatal Research Study
Agilent Technologies Inc. announced its microarrays were used in a landmark prenatal research study published on Thursday in the New England Journal of Medicine.
Monday, December 10, 2012
Agilent Technologies Appoints Ron Nersesian President and COO
The company's board of directors has appointed Ron Nersesian Agilent president and chief operating officer, effective immediately.
Thursday, November 15, 2012
Agilent Technologies Names Diagnostics and Genomics Group President
Lars Holmkvist appointed as president of company’s Diagnostics and Genomics Group (DGG) and a senior vice president of Agilent, effective immediately.
Friday, September 14, 2012
Scientific News
Will Brain Palpation Soon Be Possible?
Researchers have developed non-invasive brain imaging technique which provides the same information as physical palpation.
Groundbreaking Computer Program Diagnoses Cancer in Two Days
Researchers have combined genetics with computer science and created a new diagnostic technology can with 85 per cent certainty identify the source of the disease and thus target treatment and, ultimately, improve the prognosis for the patient.
Detecting HIV Diagnostic Antibodies with DNA Nanomachines
New research may revolutionize the slow, cumbersome and expensive process of detecting the antibodies that can help with the diagnosis of infectious and auto-immune diseases such as rheumatoid arthritis and HIV.
Horse Illness Shares Signs of Human Disease
Horses with a rare nerve condition have similar signs of disease as people with conditions such as Alzheimer’s, a study has found.
Compound Doubles Up On Cancer Detection
Researchers have found that tagging a pair of markers found almost exclusively on a common brain cancer yields a cancer signal that is both more obvious and more specific to cancer.
The Age of Humans Controlling Microbes
Engineered bacteria could soon be used to detect environmental toxins, treat diseases, and sustainably produce chemicals and fuels.
Predictive Model for Breast Cancer Progression
Biomedical engineers have demonstrated a proof-of-principle technique that could give women and their oncologists more personalized information to help them choose options for treating breast cancer.
Are Changes to Current Colorectal Cancer Screening Guidelines Required?
Editorial suggests more research is needed to pinpoint age to end aggressive screening.
New Molecular Marker for Killer Cells
Cell marker enables prognosis about the course of infections.
Sniffing Out Cancer
Scientists have been exploring new ways to “smell” signs of cancer by analyzing what’s in patients’ breath.
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,600+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,800+ scientific videos