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FDA Approves Dako's HER2 IQFISH Assay

NEW YORK (GenomeWeb News) – Dako today announced that the US Food and Drug Administration has approved its HER2 IQFISH pharmDx assay for marketing in the US.

HER2 IQFISH pharmDx is a fluorescence in situ hybridization assay based on Dako's "instant quality in situ hybridization" buffer chemistry, and according to the firm, the assay will reduce the cancer diagnosis turnaround time to three-and-a-half hours from the current two days.

The assay is the first product based on the Dako IQISH technology to receive FDA approval and can offer laboratories greater speed as well as accuracy in identifying HER2 gene status, Dako said.

HER2-positive breast cancer tends to be especially aggressive and less responsive to hormone treatment, it said. As a result, specifically targeted treatments are sometimes required.

"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 David Hardisson from the department of pathology at the University Hospital La Paz, School of Medicine, Autonomous University of Madrid.

HER2 IQFISH pharmDx is CE marked and has been available in parts of Europe for the past year, Dako noted.

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