For Immediate Release

MARLBOROUGH, Mass., (Mar 16, 2006) - Cytyc Corporation, a leading women's health company, today announced that studies evaluating the accuracy and cost-effectiveness of the ThinPrep(R) Imaging System for cervical cancer screening were presented at the 2006 Biennial Meeting of the American Society for Colposcopy and Cervical Cancer (ASCCP) this week in Las Vegas. One study examined the incremental value of high-risk (HR) human papillomavirus (HPV) DNA testing in combination with the ThinPrep Imaging System. The second study compared the cost-effectiveness of cervical cancer screening with the ThinPrep Imaging System compared to various other cervical screening strategies.

The first study, "Age-Specific Detection of High Risk HPV DNA in Cytologically Normal, Computer-Imaged ThinPrep(R) Pap Samples," was conducted at Brigham and Women's Hospital and Harvard Medical School. The investigators identified 1001 patients, aged 30 to 45 years, with a cytologically normal result following image-directed screening with the ThinPrep Imaging System, which were then tested for HR HPV using the Hybrid Capture 2 (hc2) method. The patients were stratified into three age groups: 30 to 35, 36 to 40, and 41 to 45. The results showed that the rates of hc2 HR-HPV DNA positivity were 6.7, 3.0, and 2.9 percent respectively, and 3.9 percent overall in the cytologically negative cohort. When the hc2 positive samples were tested by PCR for specific HPV type, only one-half were found to have types known to be associated with the development of cervical cancer. The authors concluded, "The HR HPV rates in women with a cytologically negative, computer-imaged ThinPrep test result appear to be extremely low. If these findings are confirmed in future studies, current screening guidelines supporting the addition of HPV testing to the liquid-based Pap test in women over 30 may need to be re-considered."

The second study, "A Health Economic Model to Determine the Cost-Effectiveness of Cervical Cancer Screening Methods," was conducted by Quintiles Strategic Research Services, an independent contract research organization. The objective of the analysis was to estimate the clinical and economic benefits of several cervical cancer primary screening strategies including: Pap smear, ThinPrep Pap Test, ThinPrep Imaging System, Pap smear plus HPV Test, and ThinPrep Pap Test plus HPV Test. Estimates from the literature were used to build a state-transition health economic model that follows a cohort of 100,000 women from age 18 to 95 years to simulate the natural history of cervical cancer and to estimate health outcomes, resource utilization, and accumulated costs. The model was developed for a U.S. managed care perspective and results were calculated over the course of a managed care lifetime (defined as ages 18 to 64.5). The analysis concluded that "the Incremental Cost Effectiveness Ratio (ICER) comparisons showed that the ThinPrep, conventional Pap smear + HPV and ThinPrep + HPV strategies were dominated by the ThinPrep Imaging System, meaning the Imaging System was both more effective and less costly. Over the course of a managed care lifetime, the Thin Prep Imaging System screening method is the most cost-effective screening strategy followed by ThinPrep alone, with total costs for these strategies being far less than the two strategies employing HPV DNA testing."

These studies demonstrate the potential clinical and cost benefits of the ThinPrep Imaging System. "The improved sensitivity of disease detection provided by the ThinPrep Imaging System may lessen the potential value of combining HPV testing with this system of cervical cancer screening," said Ellen Sheets, M.D., Cytyc's chief medical officer. "It is particularly gratifying that this data could be presented at the ASCCP Biennial Meeting, as the Society's members comprise some of the most important thought leaders in the field of cervical cancer screening."