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Ikonisys’ OncoFISH breast cancer test

This article was originally published in The Gray Sheet

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Executive Summary

Firm gains 510(k) clearance Oct. 28 for its OncoFISH non-invasive HER-2 gene test for breast cancer. The device is a "fully automated" microscopy application for determining HER-2 status with breast cancer specimens processed with Abbott's PathVysion HER-2 DNA probe kit, according to the company. The test is run on Ikonisys' CellOptics system. The presence of HER-2 gene amplification indicates whether a patient is a candidate for treatment with Genentech's Herceptin (trastuzumab)

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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