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FDA Approves Ventana Breast Cancer Test on Additional Platform

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved Ventana Medical Systems' Inform HER2 Dual ISH DNA Probe cocktail assay on the Ventana Benchmark Ultra automated slide staining platform for sale in the US, the company said today.

The assay, which was originally approved by FDA in June 2011 for use on Ventana's BenchMark XT instrument, is for determining HER2 gene status in breast cancer tissue and whether a patient may be a candidate for treatment with Herceptin (trastuzumab).

The assay detects both HER2 and chromosome 17 on a single slide using standard light microscope, said Ventana, a Roche company. Greg Yap, Lifecycle Leader, Advanced Staining Assays at Ventana, said in a statement that in a clinical study comparing the assay to FISH, more patients would have received the correct result and been identified as potential candidates for Herceptin using the Dual ISH test.

Ventana's assay is more user-friendly and reduces the turnaround time for test results to 13 hours, compared to two to three days with standard HER2 FISH testing, Yap added.

The HER2 Dual ISH DNA Probe is the latest test to receive FDA clearance for assessing breast cancer patients for treatment with Herceptin. Life Technologies, Abbott Molecular's Vysis unit, and Dako also have such tests cleared by the agency.

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