Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

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

Join For Free

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 3,500+ scientific posters on ePosters
  • More Than 5,000+ 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 TechnologyNetworks.com 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

Impact of Emerging Contaminants in Our Water Supply
Emerging contaminants, any synthetic or naturally occurring chemical not commonly monitored in the environment, in our water supply are becoming of increasing concern due to their potential ecological and/or human health effects.
Friday, September 16, 2016
Agilent Technologies to Build New Facility in Colorado
Agilent buys 20 acres in Weld County to increase pharmaceutical manufacturing capacity.
Wednesday, August 10, 2016
Dako Announces CE Mark for Companion Diagnostic
Dako has announced the CE Mark certification for use of PD-L1, a companion diagnostic to Merck's anti-PD-1 immunotherapy Keytruda.
Thursday, August 04, 2016
Agilent to Acquire iLab Solutions
Companies have announced they have signed a definitive agreement under which Agilent will acquire substantially all of the assets of iLab, the market leader in cloud-based solutions for core laboratory management.
Wednesday, June 29, 2016
Agilent, Eurofins Genomics Collaborate
Agilent plans to offer custom components and an assembled plasmid service for Agilent’s SureVector next-generation cloning kits through a collaboration with Eurofins.
Monday, March 14, 2016
Best Practices for Breast Cancer Diagnosis
Agilent has published “Breast Cancer Diagnosis: Past, Present and Future,” a white paper on the use of immunohistochemistry in diagnosing and treating breast cancer.
Monday, March 14, 2016
Agilent Invests $80M in Lasergen
Company has announced that it has invested $80 million in Lasergen, with innovative next-generation sequencing technology for clinical applications.
Friday, March 11, 2016
Agilent Technologies Announces Early Access to Custom guideRNA for Functional Genomics
Company has announced a program that gives biologists conducting functional genomics research early access to a potential new resource.
Saturday, February 13, 2016
Agilent Technologies and 10x Genomics Announce Collaboration
Company has announced collaboration to develop a premium exome that provides a streamlined workflow for 10x Genomics'Chromium platform.
Friday, February 12, 2016
Agilent Wins Award for Innovation in LC
Dual-needle technology enhances speed, flexibility.
Thursday, January 28, 2016
Agilent Extends Agreement with PerkinElmer on Bioanalyzer Chips
PerkinElmer supplies chips for Agilent's popular 2100 Bioanalyzer system.
Thursday, January 21, 2016
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
Scientific News
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
Mass Spec Technology Drives Innovation Across the Biopharma Workflow
With greater resolving power, analytical speed, and accuracy, new mass spectrometry technology and techniques are infiltrating the biopharmaceuticals workflow.
One Step Closer to Precision Medicine for Chronic Lung Disease Sufferers
A study led by University of North Carolina at Chapel Hill, and National Jewish Health, has provided evidence of links between SNPs and known COPD blood protein biomarkers.
ReadCoor Launched to Commercialize 3D Sequencing Tech
ReadCoor will leverage the Wyss Institute’s method for simultaneously sequencing and mapping RNAs within cells and tissues to advance development of diagnostics.
Ancient Eggshell Protein Breaks Through DNA Time Barrier
Fossil proteins from a 3.8million year-old eggshell have been identifed, suggests proteins could give insight into evolutionary tree.
Monkeys Protected by Zika DNA Vaccine
Experimental Zika virus DNA vaccines successfully protected monkeys against Zika infection.
NCI Collaborates with Multiple Myeloma Research Foundation
NCI collaborates with MMRF to incorporate genomic and clinical data into NCI Genomic Data Commons database.
New Imaging Technique in Alzheimer’s Disease
Study confirms new imaging technique corresponds a higher degree of actual brain changes.
Anti-Inflammatory Drugs Could Strengthen Airway Immunity
Mold toxins can weaken the airways' clearing mechanisms and immunity, but PKC inhibitors showed promise as a treatment.
Regulatory RNA Essential to DNA Damage Response
Researchers discover a tumour suppressor is stabilized by an RNA molecule, which helps cells respond to DNA damage.
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
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!