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New Quantitative Survey Confirms Improved Performance of ThinPrep Pap Test.


Business Editors/Health/Medical Writers

BIOWIRE2K

BOXBOROUGH, Mass.--(BUSINESS WIRE)--July 2, 2003

An independent, quantitative survey published this week reports on the improved sensitivity and specificity of 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.  compared to the conventional Pap smear Pap smear
 or Papanicolaou smear

Sample of cells from the vagina and cervix of the uterus for laboratory staining and examination to detect genital herpes and early-stage cancer, especially of the cervix. Developed by the Greek-born U.S.
 for the detection of cervical dysplasia Cervical dysplasia
Dysplasia is the abnormal growth of the epithelial cells. This is what a Pap smear will detect in the cervix.

Mentioned in: Pelvic Exam

cervical dysplasia
 reported Cytyc Corporation (Nasdaq: CYTC). The study analyzed 24 published studies to assess the consistency of the two methods and to assess the accuracy of each method.

The study by Ovadia Abulafia, M.D., and others, appears in the July 2003 issue of Gynecologic Oncology. The authors conducted searches of computerized databases for literature published between January 1990 and September 2002. The searches yielded 47 potentially relevant articles. The authors then identified 24 articles that met the criteria established for their evaluation.

Based on their findings the authors conclude, "According to our analysis, wide application of the ThinPrep technology potentially may result in cytological cytological, cytologic

pertaining to cytology.


cytological examination
examination of material for purposes of cytology. Carried out on cerebrospinal fluid, joint fluid, aspirates of body cavities and cystic lesions.
 diagnosis of an additional 162,000 patients with HGSIL HGSIL High-grade squamous intraepithelial lesion, see there  and 3000 patients with invasive cervical carcinoma whom otherwise would have been missed by utilization of conventionally prepared Papanicolau smears (false-negative smears). We conclude that ThinPrep liquid-based cervical 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.  should be considered the standard of care, as this technology has the potential to further reduce the incidence and increase the survival of patients with invasive cervical carcinoma as a result of early detection."

"This important independent study is a significant addition to the formidable body of evidence demonstrating the improved clinical performance of the ThinPrep Pap Test," said Patrick J. Sullivan, Cytyc's chairman, president, and chief executive officer. "I believe the consistency of the reported benefits in the published literature serves to validate our claims of the improved diagnostic performance of the ThinPrep Pap Test and provides a clear differentiation from other technologies."

"This is the second independent analysis of previously published studies evaluating the ThinPrep Pap Test," added James Linder, M.D., Cytyc's chief medical officer. "In 2001, Bernstein et al. published a meta-analysis of 25 studies in the American Journal of Obstetrics and Gynecology obstetrics and gynecology

Medical and surgical specialty concerned with the management of pregnancy and childbirth and with the health of the female reproductive system.
 demonstrating that the ThinPrep Pap Test improves diagnosis of high-grade squamous intraepithelial lesions (HSIL HSIL High-grade squamous intraepithelial lesion, see there ) compared to the conventional Pap smear. The current quantitative analysis Quantitative Analysis

A security analysis that uses financial information derived from company annual reports and income statements to evaluate an investment decision.

Notes:
 by Abulafia et al. applies different methodology and inclusion criteria, focusing primarily on split-sample studies, yet the findings continue to confirm improved diagnostic performance."

Cytyc Corporation designs, develops, manufactures, and markets the ThinPrep(R) System for use in 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 System is widely used for cervical cancer screening and is the platform from which the Company has launched its expansion into breast cancer risk assessment with the FirstCyte(TM) Breast Test. The ThinPrep System consists of the ThinPrep(R) 2000 Processor, ThinPrep(R) 3000 Processor, ThinPrep(R) Imaging System, 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. FirstCyte is a trademark of Cytyc Corporation for which registration has been applied.

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, product acceptance, management of growth, risks associated with litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
, 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 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 and its most recent Quarterly Report on Form 10-Q filed with the Commission. 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.
COPYRIGHT 2003 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2003, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jul 2, 2003
Words:761
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