Corporate Banner
Satellite Banner
Scientific Communities
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 2,800+ scientific posters on ePosters
  • More Than 4,000+ 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 Signs Agreement with Thermo Fisher Scientific
Agreement to exchange instrument controls to improve the productivity and user experience.
Thursday, November 12, 2015
Agilent Completes Acquisition of Seahorse Bioscience
Agilent has completed the acquisition of Seahorse Bioscience, a leader in providing instruments and assay kits for measuring cell metabolism and bioenergetics.
Tuesday, November 03, 2015
Agilent Recognizes Australian Genome Research Facility as Certified Service Provider
Nonprofit organization offers scientists access to leading-edge technologies.
Saturday, October 31, 2015
Agilent Announces Opening of Life Science Research Center
Facility designed to advance multi-omics research.
Thursday, September 24, 2015
Agilent to Acquire Seahorse Bioscience
Acquisition complements Agilent’s market-leading separations and mass spectrometry solutions, expands pharma offerings.
Thursday, September 10, 2015
Agilent, Singapore Institute Collaborate
Agilent Technologies and Singapore's Bioprocessing Technology Institute today announced a collaboration to develop new analytical approaches to specific protein-linked sugar compounds.
Wednesday, July 15, 2015
Agilent Collaborate with A*STAR’s Bioprocessing Technology Institute
Collaboration addresses a critical need in the biopharmaceutical industry.
Tuesday, July 14, 2015
Agilent Technologies and Waters Corporation Formalize Instrument Control Exchange
Agilent Technologies Inc. and Waters Corp have announced a formal agreement to exchange instrument controls to improve the productivity of customers who own software and instruments from both companies.
Wednesday, July 01, 2015
Agilent Technologies Launches New Products for Analyzing Biotherapeutics
Expanded AdvanceBio portfolio enables scientists to speed research and lower costs.
Thursday, June 25, 2015
Agilent to Focus on "Powerful Partnerships, Inspiring Results" at ASMS 2015
Company to introduce solutions enabling new standards in mass spectrometry, lab productivity.
Friday, May 29, 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
Utilizing Fast HPLC Screening Methods for the Detection of Steroids
Analysis of steroids improved by choosing the optimal HPLC column for the separation.
Saturday, January 17, 2015
Agilent Names Alacris Theranostics as Certified Provider of Target Enrichment Services
Customers receive consistent data quality, reproducibility and reliability.
Saturday, January 17, 2015
Benefits of SPE for the Analysis of Mycotoxins
Fast and cost-effective sample preparation is essential for the analysis of mycotoxins in food and feed.
Wednesday, January 14, 2015
Scientific News
High Throughput Mass Spectrometry-Based Screening Assay Trends
Dr John Comley provides an insight into HT MS-based screening with a focus on future user requirements and preferences.
Promising Drug Combination for Advanced Prostate Cancer
A new drug combination may be effective in treating men with metastatic prostate cancer. Preliminary results of this new approach are encouraging and have led to an ongoing international study being conducted in 196 hospitals worldwide.
A Cellular Symphony Responsible for Autoimmune Disease
Broad Institute researchers have used a novel approach to increase our understanding of the immune system as a whole.
When it Comes to Breast Cancer, Common Pigeon is No Bird Brain
If pigeons went to medical school and specialized in pathology or radiology, they’d be pretty good at distinguishing digitized microscope slides and mammograms of normal vs. cancerous breast tissue, a new study has found.
Editing of LIMS Data Made Faster and More Efficient in Matrix Gemini
The latest version of the Matrix Gemini LIMS (Laboratory Information Management System) from Autoscribe Informatics now provides faster and more efficient editing of LIMS data by eliminating the need for a second editing screen.
University of Edinburgh, Selcia Achieve Key Milestones in Drug Development Program
Scientists from the University of Edinburgh, working with Selcia, have successfully passed the 20-month milestone targets of a 30-month Wellcome Trust SDDi £2.5 million project to design novel treatments for sleeping sickness.
Red Clover Genome to Help Restore Sustainable Farming
The Genome Analysis Centre (TGAC) in collaboration with IBERS, has sequenced and assembled the DNA of red clover to help breeders improve the beneficial traits of this important forage crop.
How a Genetic Locus Protects Adult Blood-Forming Stem Cells
Mammalian imprinted Gtl2 protects adult hematopoietic stem cells by restricting metabolic activity in the cells' mitochondria.
Genetic Basis of Fatal Flu Side Effect Discovered
A group of people with fatal H1N1 flu died after their viral infections triggered a deadly hyperinflammatory disorder in susceptible individuals with gene mutations linked to the overactive immune response, according to a recent study.
New Tech Vastly Improves CRISPR/Cas9 Accuracy
A new CRISPR/Cas9 technology developed by scientists at UMass Medical School is precise enough to surgically edit DNA at nearly any genomic location, while avoiding potentially harmful off-target changes typically seen in standard CRISPR gene editing techniques.
Scroll Up
Scroll Down
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
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos