Cytyc Announces UK Appraisal Committee Preliminary Report Recommends Use of Liquid-Based Cytology.Business Editors/Health/Medical Writers BOXBOROUGH, Mass.--(BUSINESS WIRE)--April 14, 2003 Cytyc Corporation (Nasdaq:CYTC) announced today that the U.K. National Institute for Clinical Excellence (NICE) Appraisals Committee has issued a preliminary evaluation report recommending the use of liquid-based cytology cytology (sītŏl`əjē), in biology, the study of the structure of all normal and abnormal components of cells and the changes, movements, and transformations of such components. "as the primary means of collecting samples in the cervical screening programme in England and Wales England and Wales are both constituent countries of the United Kingdom, that together share a single legal system: English law. Legislatively, England and Wales are treated as a single unit (see State (law)) for the conflict of laws. ." The Appraisal Consultation Document was posted on the NICE website today and is intended to generate comments on the contents. The document does not constitute the Institute's formal guidance. The NICE Appraisals Committee evaluated the use of liquid-based cytology (LBC LBC Luton Borough Council LBC Liquid Based Cytology LBC Lebanese Broadcasting Corporation LBC Lancaster Bible College (Pennsylvania) LBC Long Beach California LBC Long Beach City LBC Albanian Airlines ) for cervical cancer Cervical Cancer Definition Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors. screening in order to provide guidance to the National Health Service (NHS NHS abbr. National Health Service NHS (in Britain) National Health Service ). The committee assessed a number of factors related to this technology including sensitivity, specificity, specimen adequacy, laboratory efficiency, and cost. In considering all these factors, the Appraisals Committee concluded that, "There is currently insufficient evidence insufficient evidence n. a finding (decision) by a trial judge or an appeals court that the prosecution in a criminal case or a plaintiff in a lawsuit has not proved the case because the attorney did not present enough convincing evidence. to recommend one LBC product over another." However, the Committee did state, "An important factor in the assessment of the increased sensitivity of LBC was its enhanced ability to detect high-grade (severe dyskaryosis), which was confirmed by the results from the pilot study." The previously reported results of the pilot study showed that only the ThinPrep(R) Pap Test Pap test, Pap smear, or Papanicolaou test (păp'ənē`kəlou), medical procedure used to detect cancer of the uterine cervix. demonstrated a significant increase in the detection of severe dyskaryosis. "While we recognize that this is a preliminary report and is subject to change, we are encouraged by the Committee's recommendation," said Patrick J. Sullivan, Cytyc's chairman, president, and chief executive officer. "We look forward to the final report and the issuance of guidance to the NHS." The Committee will reconsider the Appraisal Consultation Document in May of this year and issue a Final Appraisal Determination (FAD) thereafter. The FAD may be used as the basis for the Institute's guidance to the NHS expected in August 2003. Cytyc Corporation develops, manufactures, and markets products for medical diagnostic applications primarily focused on women's health Women's Health Definition Women's health is the effect of gender on disease and health that encompasses a broad range of biological and psychosocial issues. . The ThinPrep(R) System consists of the ThinPrep(R) 2000 Processor, ThinPrep(R) 3000 Processor, and related reagents, filters, and other supplies. Cytyc is traded on The Nasdaq Stock Market Nasdaq stock market The first electronic stock market listing over 5000 companies. The Nasdaq stock market comprises two separate markets, namely the Nasdaq National Market, which trades large, active securities and the Nasdaq Smallcap Market that trades emerging growth companies. under the symbol CYTC. Cytyc and ThinPrep are registered trademarks of Cytyc Corporation. Forward-looking statements in this press release are made pursuant to the provisions of Section 21E of the Securities Exchange Act of 1934. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements relating to the Company's financial condition, operating results and future economic performance, and management's expectations regarding future growth opportunities, product acceptance and business strategy, constitute forward-looking statements. These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties, which could cause actual outcomes and results to differ materially from those statements. Risks and uncertainties include, among others, dependence on key personnel and proprietary technology, uncertainty of product development efforts, management of growth, risks associated with competition and competitive pricing pressures, risks associated with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. regulatory approval processes and any domestic and international healthcare reimbursement policies, and other risks detailed in the Company's filings with the Securities and Exchange Commission, including under the heading "Certain Factors Which May Affect Future Results" in its 2002 Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. . The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in Company expectations or events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. |
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