AICXE Applied Imaging (MM)

Applied Imaging Announces FDA Clearance to Market Breast Cancer Assessment Test SAN JOSE, Calif., May 10 /PRNewswire-FirstCall/ -- Applied Imaging Corp. (NASDAQ:AICXE) announced today that that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Ariol(R) 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(R) 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(R) Her-2/neu FISH application assists in the analysis of a complex test that is an important factor in the evaluation and selection of certain breast cancer patients for Genentech's Herceptin (Trastuzumab) therapy. Herceptin is the first humanized antibody approved for the treatment of Her-2 positive metastatic breast cancer. Herceptin targets and blocks the overexpression of Her-2 protein. Research indicates that women with Her-2 positive metastatic breast cancer have a more aggressive disease, greater likelihood of recurrence, poorer prognosis and approximately half the life expectancy of women with Her-2 negative breast cancer. "This FDA clearance is consistent with our plan to enhance the menu and add value to our Ariol(R) pathology workstation for both clinical and research applications", said Robin Stracey, President and Chief Executive Officer of Applied Imaging Corp. "The addition of this application to the existing breast cancer panel available on Ariol(R) provides our customers with an important diagnostic tool for identifying those breast cancer patients most appropriate for Herceptin therapy". The Ariol(R) Her-2/neu FISH application uses the PathVysion Her-2/neu DNA Probe kit from Vysis, Inc., Downers Gove, IL. Ariol(R) is an automated scanning microscope and image analysis system which is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and quantification of cells of interest based on particular color, intensity, size, pattern, and shape. A number of research applications are also available on Ariol(R) including Angiogenesis, DNA Ploidy and Tissue Microarray. About Applied Imaging Applied Imaging Corp., based in San Jose, California, is the leading supplier of automated imaging and image analysis systems for the detection and characterization of chromosomes and molecular markers in genetics and pathology laboratories. The Company develops, manufactures and markets a range of scanning and image analysis systems for both conventional (brightfield) and fluorescent microscopic analysis of cellular and tissue specimens. Products are sold to hospital laboratories, cancer centers, prenatal clinics and research institutions for both research and clinical purposes. The Company has installed over 3,500 of its systems in over 1000 laboratories in more than 60 countries around the world. Beyond its core business, through its wholly-owned subsidiary, CTC, Inc., the Company is also developing a system for the detection, quantification and characterization of tumor cells in the blood of cancer patients. More information about Applied Imaging can be found at http://www.aicorp.com/. CCG Investor Relations Applied Imaging Corp. Crocker Coulson, President Terry Griffin, 15300 Ventura Boulevard, Suite 303 Chief Financial Officer Sherman Oaks, CA 91403 120 Baytech Drive, (818) 789-0100 San Jose, CA 95134 (408) 719-6417 DATASOURCE: Applied Imaging Corp. CONTACT: Crocker Coulson, President of CCG Investor Relations, +1-818-789-0100, , for Applied Imaging Corp.; or Terry Griffin, Chief Financial Officer of Applied Imaging Corp., +1-408-719-6417, Web site: http://www.aicorp.com/

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