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Breast Cancer
U.S. FDA grants clearance to market breast cancer assessment test
June 6th, 2005
Applied Imaging Corp. (AICXE) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Ariol Her-2/neu FISH application, which is designed to detect Her-2/neu gene amplification in breast cancer biopsy samples via fluorescence in situ hybridization (FISH). The application complements and completes the breast cancer panel on the Ariol system which now includes 510(k) cleared assays for Her-2/neu Immunohistochemistry (IHC), Her-2/neu FISH, Estrogen Receptor, and Progesterone Receptor. The Ariol Her-2/neu FISH application assists in the analysis of a complex test that is an important factor in the evaluation and...
Source: Biotech Business Week (2005-06-06)
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