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

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.