FDA Approves Dako’s FISH Assay for Cancer Diagnostics

Dako, an Agilent Technologies company, has received FDA approval to sell a new technology in the United States that will reduce the turnaround time for cancer evaluation from two days to just three and a half hours.

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. 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-positive breast cancers tend to be more aggressive than other types of breast cancer, and they are less responsive to hormone treatment. For that reason, treatments that specifically target HER2—the antibody trastuzumab, for example—are often considered.

“Every second counts when waiting for test results that will indicate how to treat your cancer most effectively,” said Lars Holmkvist, president of Agilent’s Diagnostics and Genomics Group, which includes Dako.




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