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Four International Studies Showing Benefits of ThinPrep(R) Pap Test Published in British Cytology Journal
MARLBOROUGH, Mass., (Apr 3, 2006) - Cytyc Corporation, a leading women's health company, today announced that four studies describing a variety of clinical and cost benefits of the ThinPrep(R) Pap Test were published in the April 2006 issue of Cytopathology, the official journal of the British Society of Clinical Cytology. The studies were conducted in Canada, Scotland, Ireland, and England. A study by Duggan et al., of the University of Calgary in Canada, compared ThinPrep Pap Test and conventional cytology results in a Canadian cohort. The study included more than 2,000 patients in each group. The authors report a statistically significant increase in the detection of high-grade squamous intraepithelial lesions (HSIL) in patients screened with the ThinPrep Pap Test compared to those screened with the conventional smear. The study also reported that follow-up results of HSIL and more severe lesions showed the ThinPrep Pap Test group had a higher number of tests confirmed as HSIL or malignant and exceeded the number of confirmed conventional tests by 60 percent. A study conducted by Dr. A. R. W. Williams at the Royal Infirmary of Edinburgh in Scotland compared cytology results for a 12-month period when the ThinPrep Pap Test was used exclusively versus a 12-month period when conventional smears were used. Results of the analysis showed the reporting rates for all grades of cytologic abnormality increased in the ThinPrep Pap Test period, while the positive predictive value (PPV) also improved in this group. In addition, the rate of unsatisfactory specimens fell from 13.6 percent with conventional smears to 1.9 percent with the ThinPrep Pap Test. "The Scottish Cervical Screening Programme was the first national program to commit to complete conversion to the ThinPrep Pap Test," said Dr. Williams. "I believe our data as well as the cumulative findings of the other studies published in the current issue of Cytopathology, clearly validate that decision. We have been very pleased with the performance of the ThinPrep Pap Test in our laboratory, and there have been important downstream benefits to colposcopy clinics and to the women being screened." Doyle et al., at St. Luke's Hospital in Dublin, assessed the effects on productivity with implementation of the ThinPrep Pap Test over a two-year period. Based on output of cases per medical scientist, there was a 31 percent increase in output at 73 percent conversion to the ThinPrep Pap Test. The authors also reported "a definite decreasing trend" in the overall number of unsatisfactory cases as the percentage conversion to the ThinPrep Pap Test increased. In a study conducted at Manchester Royal Infirmary and Stepping Hill Hospital, Stockport, England, Dowie et al., evaluated the impact on cervical smear reader efficiency with implementation of the ThinPrep Pap Test. The investigators conducted a series of timing surveys, in which the slide readers used timers to record time taken to examine and report each slide. The author reported that the timing surveys confirm that the ThinPrep Pap Test can improve laboratory efficiency. "The results from international institutions continue to build on the substantial body of evidence that shows improvement in productivity and clinical effectiveness wherever the ThinPrep Pap Test is implemented in the world," said David Harding, president Cytyc International. "It is also noteworthy that all four studies evaluating liquid-based cytology, published in this prestigious journal, utilized the ThinPrep Pap Test exclusively." About HologicHologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic and medical imaging systems dedicated to serving the healthcare needs of women, and a leading developer of innovative imaging technology for digital radiography and breast imaging. Hologic’s core business units are focused on mammography and breast biopsy, osteoporosis assessment, and mini C-arm and extremity MRI imaging for orthopedic applications. Cytyc’s products cover a range of cancer and women’s health applications, including cervical cancer screening, preterm birth screening, treatment of excessive menstrual bleeding, radiation treatment of patients with early-stage breast cancer. Forward-Looking Statements 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 Cytyc's future financial condition, operating results and economic performance, and management's expectations regarding key customer relationships, 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 customers as well as reliance on proprietary technology, uncertainty of product development efforts and product acceptance, management of growth and product diversification, entry into new market segments domestically and new markets internationally, risks associated with litigation, the effective integration of acquired businesses and technologies, competition and competitive pricing pressures, risks associated with the FDA regulatory approval processes and healthcare reimbursement policies in the United States and abroad, introduction of technologies that are disruptive to Cytyc's business and operations, the impact of new accounting requirements and governmental rules and regulations, as well as other risks detailed in Cytyc's filings with the Securities and Exchange Commission, including under the heading "Risk Factors" in its 2005 Annual Report on Form 10-K filed with the Commission. Cytyc cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made. Cytyc disclaims any obligation to publicly update or revise any such statements to reflect any change in its 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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