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Applied Imaging, US Food and Drug Administration, Vysis

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Applied Imaging has received 510(k) clearance from the US Food and Drug Administration to market its Ariol Her-2/neu FISH application, which is designed to detect Her-2/neu gene amplification in breast cancer biopsy samples using fluorescence in situ hybridization, the company said.

The application is the final addition to the breast cancer panel on the Ariol system which also includes assays for Her-2/neu immunohistochemistry, Her-2/neu FISH, estrogen receptor, and progesterone receptor.

The Ariol Her-2/neu FISH application uses the PathVysion Her-2/neu DNA Probe Kit from Vysis, a subsidiary of Abbott Labs.

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