Breast Cancer

FDA clears to market breast cancer assessment applications

Published in Women's Health Weekly, April 22nd, 2004

Applied Imaging Corp. (AICX) announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market its automated applications for Estrogen Receptor (ER) and Progesterone Receptor (PR) analysis in breast cancer patients.

These applications utilize Applied Imaging's Ariol system to assist in the analysis of tests that are important factors in the selection of certain breast cancer patients to receive hormonal therapies such as Tamoxifen. Along with the previously cleared Her-2/neu application, ER and PR comprise the most commonly used panel of immunohistochemistry tests for breast cancer assessment in the clinical pathology...

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Source: Women's Health Weekly (2004-04-22)

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