A fluorescence in situ hybridization (FISH) assay will reduce the turnaround time for cancer evaluation from two days to three and a half hours.
This technology will ease the waiting time and associated anxiety for the patient and allow physicians to more quickly initiate targeted cancer treatments.
Dako, an Agilent Technologies Company (Carpinteria, CA, USA) has introduced instant quality in situ hybridization (IQISH) technology in the United States of America. The HER2 IQFISH pharmDx test is a FISH assay, is the first product approved by the US Food and Drug Administration (Silver Spring, MD, USA) that uses the Dako IQISH technology, which is based on Dako's fast IQISH hybridization buffer chemistry.
The human epidermal growth factor receptor 2 (HER2) protein is encoded by gene called 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. The HER2 IQFISH pharmDx assay can support laboratories in identifying HER2 gene status with great accuracy and now, speed. 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 IQFISH technology is also nontoxic, as it replaces a hazardous formamide buffer with a safer ethylene carbonate, contributing to a healthier work environment in the pathology laboratory. Lars Holmkvist, the CEO of Dako, said, "Every second counts when waiting for test results that will indicate how to treat your cancer most effectively. Dako is extremely proud to get the FDA's approval to introduce this offering to our US customers."
Kenneth J. Bloom, MD, FCAP, chief medical officer, Clarient Diagnostic Services Inc (Aliso Viejo, CA, USA) said, "HER2 IQFISH pharmDx will provide more timely results, allowing us to incorporate FISH analysis into our routine workflow as easily as immunohistochemistry.” 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.
US Food and Drug Administration
Clarient Diagnostic Services Inc.