Cytyc Submits PMA Application for ThinPrep Imaging System and PMA Supplement for Testing of Sexually Transmitted Diseases Directly From ThinPrep Pap Test Vial.

Business Editors and Health/Medical Writers

BOXBOROUGH, Mass.--(BW HealthWire)--Jan. 7, 2002

Cytyc Corporation (Nasdaq:CYTC) announced today the submission of a Premarket Approval (PMA) Application to the U.S. Food and Drug Administration (FDA) for the ThinPrep(R) Imaging System. The ThinPrep Imaging System is an interactive computer system that will assist cytotechnologists in the primary screening and diagnosis of ThinPrep(R) Pap Test(TM) slides. The system combines imaging technology to identify diagnostic fields of interest with automated microscope stage movements to facilitate locating these fields. The system is expected to increase a cytology laboratory's screening productivity while leveraging the increased sensitivity of the ThinPrep Pap Test.

This PMA Application is supported by a prospective, multi-center clinical study that evaluated the performance of the ThinPrep Imaging System in direct comparison to a manual review method. More than 9,500 patients from both low-risk and high-risk populations were included in the study.

In addition, the company has submitted a PMA Supplement to the FDA to allow testing for Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG) directly from the ThinPrep Pap Test vial using Roche Diagnostics Corporation's COBAS AMPLICOR(TM) automated system.

The PMA Supplement is supported by a clinical study conducted jointly with Roche Diagnostics Corporation that included 1,750 patients from four separate clinical sites. Cervical specimens were collected in the ThinPrep Pap Test PreservCyt(R) collection vial. A microscope slide was processed first using a ThinPrep Processor and an aliquot was then taken from the residual material in the vial and tested for CT and NG using Roche's polymerase chain reaction-based COBAS AMPLICOR system. The results were compared to specimens collected directly into Roche's M4 culture transport medium.

"We believe that these submissions represent achievement of significant milestones in expanding the value of the ThinPrep(R) System. We look forward to bringing both opportunities through the FDA process and to the medical marketplace as quickly as possible," said Patrick J. Sullivan, Cytyc's president and chief executive officer.

Cytyc Corporation develops, manufactures, and markets products for medical diagnostic applications primarily focused on women's health. Cytyc's ThinPrep System is widely used for cervical cancer screening and will form the platform for the Company's expansion into breast cancer risk assessment. The ThinPrep 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 under the symbol CYTC and is a part of The Nasdaq-100 Index.

Cytyc(R), ThinPrep(R), and PreservCyt(R) are registered trademarks and ThinPrep(R) Pap Test(TM) is a trademark 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 regarding management's plans and objectives for future operations, product plans and performance, management's assessment of market factors, as well as statements regarding the strategy and plans of the Company, 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, management of growth, risks associated with competition and competitive pricing pressures, risks associated with the FDA 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 2000 Form 10-K 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.