To: Rocket Red who wrote (130246 ) 3/24/2004 8:31:48 AM From: Jim Bishop Read Replies (1) | Respond to of 150070 AICX Applied Imaging Announces FDA Clearances to Market Breast Cancer Assessment A plications ( PRNewswire-FirstCall ) SANTA CLARA, Calif., Mar 24, 2004 /PRNewswire-FirstCall via COMTEX/ -- Applied Imaging Corp. (Nasdaq: AICX) today 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(TM) 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 laboratory. The ER and PR results are used as an aid in the management, prognosis and prediction of therapy outcomes for breast cancer patients. ER and PR are hormone receptors found in cancer cells and are two examples of the clinical importance of biomarkers in the assessment of cancer patient status. Unlike normal breast cells, cancer cells arising in the breast do not always have receptors for estrogen. Breast cancers that have estrogen receptors are said to be "estrogen receptor-positive," with cancer cell growth under the control of estrogen. Such cancers are often susceptible to treatment with the drug tamoxifen, because tamoxifen works by blocking the interaction between estrogen and the estrogen receptor. "We are very pleased to receive additional FDA clearances for our Ariol system. This is validation of our work in developing automated microscopy applications to assist pathologists in the interpretation of complex cancer tests. FDA clearances for applications such as ER and PR hormone receptors for breast cancer are important to our success in the clinical pathology market," commented Carl Hull, Chief Executive Officer of Applied Imaging. "The Ariol system provides automated imaging solutions to assist the pathologist and oncologist in assessing tests that are important in helping to select breast cancer patients to receive specific targeted therapeutic agents. We anticipate the development of additional Ariol applications designed to meet the requirements of future biomarkers as they are transitioned from research and drug discovery into the clinical lab environment," continued Hull. According to the World Health Organization, there were over 1 million new cases of breast cancer diagnosed worldwide during 2000. Breast cancer accounted for 15% of all cancer deaths among women. The American Cancer Society estimates that over 215,000 new cases of breast cancer will be diagnosed in the United States during 2004 and that breast cancer will cause the death of over 40,000 American women this year. About Applied Imaging Applied Imaging Corp., based in Santa Clara, California, is the leading supplier of automated imaging systems utilized in genetics and pathology laboratories throughout the world for the analysis of chromosomes in cancer and prenatal disorders. The Company markets a range of imaging systems for fluorescence and brightfield microscopy applications, including the Company's Ariol(TM), MDS(TM), SPOT(TM), CytoVision(R), PowerGene(R) and QUIPS(R) product lines. Applied Imaging has installed in excess of 3,000 systems in over 1,000 laboratories in more than 60 countries. This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, regarding, among other matters, the outlook for the Company's ER and PR applications, our ability to succeed in the clinical pathology market, the future development of additional applications for the Company's Ariol system and possible submissions to and clearances by the FDA. Forward looking statements address matters that are subject to a number of risks, uncertainties and other factors, detailed in the Company's periodic filings with the Securities and Exchange Commission including, but not limited to, those risks and uncertainties listed in the section entitled "Management's Discussion and Analysis of Financial Condition and Results of Operations - Factors Affecting Future Results," in Applied Imaging's annual report on Form 10-K for the year ended December 31, 2002. The forward-looking statements are made as of March 24, 2004, and Applied Imaging is under no obligation to revise or update the forward-looking statements. For additional information on Applied Imaging visit the Company's website ataicorp.com . SOURCE Applied Imaging Corp. CONTACT: Barry Hotchkies, CFO of Applied Imaging Corp, +1-408-562-0250 or Jocelyn Hunter of Financial Relations Board, +1-415-248-34 3, for Applied Imaging Corp. URL: aicorp.com prnewswire.com Copyright (C) 2004 PR Newswire. All rights reserved. -0- KEYWORD: California INDUSTRY KEYWORD: CPR EDA MLM STW MTC SUBJECT CODE: WOM *** end of story ***