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FDA approves Ventana HER2 Dual ISH assay

The US Food and Drug Administration (FDA) has approved Ventana Medical Systems' INFORM HER2 Dual ISH DNA Probe cocktail assay (HER2 Dual ISH).

The HER2 Dual ISH assay is designed to determine HER2 gene status in breast cancer tissue as an aid in the assessment of patients that may be considered for treatment with Herceptin (trastuzumab).

Ventana advanced staining assays lifecycle leader Greg Yap said the INFORM HER2 Dual ISH assay improves treatment of breast cancer patients by providing clinicians increased accuracy and faster time to result compared to fluorescent in situ hybridization (FISH) assays.

"In a Ventana clinical study comparing HER2 Dual ISH to FISH, our findings showed that more patients would have received the correct result and be identified as potential candidates for Herceptin therapy using our ISH test," Yap added.

"The average turn-around time for HER2 FISH testing in breast tissue is 2-3 days as opposed to approximately 13 hours for HER2 Dual ISH testing."