Fluorescence assay for cancer diagnostics from Dako receives FDA approval

Dako, an Agilent Technologies company (Glostrup, Denmark), debuted its HER2 IQFISH pharmDx fluorescence in situ hybridization (FISH) assay in the US, and it is the first of its kind to receive FDA approval for commercialization. The technology could reduce cancer evaluation turnaround time from two days to three and a half hours and, in turn, enable faster targeted cancer treatments.

IQFISH helps to assess patients for whom trastuzumab treatment (a monoclonal antibody used to treat cancer) is being considered, says Dr. David Hardisson, University Hospital La Paz, School of Medicine, Autonomous University of Madrid, IdiPAZ (Madrid, Spain).

The assay can also support laboratories in identifying HER2 gene status with accuracy and 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, such as trastuzumab, are often considered.

It 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, says the company.

HER2 IQFISH pharmDx has been sold in Europe and countries working with CE labeling since February 2012 and, with FDA approval, it is now available in the US.

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