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Cytyc Receives Expanded Labeling to Facilitate Molecular Testing With the ThinPrep(R) Pap Test

Posted on: Thursday, 29 September 2005, 09:00 CDT

Cytyc Corporation (Nasdaq:CYTC) today announced that the U.S. Food and Drug Administration (FDA) has approved a Pre-Market Approval Supplement for the ThinPrep(R) Pap Test related to the testing of ThinPrep Pap Test samples by molecular diagnostic methods. The approval allows the removal of up to 4 ml from the PreservCyt(R) sample vial before preparing the ThinPrep Pap Test slide to better facilitate ancillary testing.

"The testing of the residual specimen in the PreservCyt sample vial for Chlamydia trachomatis, Neisseria gonorrheae and HPV is currently conducted in many laboratories based on FDA approvals previously granted to Cytyc. The ability to remove an aliquot before preparing the ThinPrep Pap Test slide greatly improves the implementation of amplified molecular testing, particularly in high-volume laboratories," said James Linder, M.D., Cytyc's chief medical officer.

"We are extremely pleased to provide this capability to our customers. The ThinPrep Pap Test is the only liquid-based cytology method to have FDA approval for specific molecular diagnostic tests. Our ThinPrep Pap Test collection vial serves as a platform, enabling ThinPrep plus Imaging and testing for important sexually transmitted infections from a single patient specimen. This newly approved capability to remove a sample for molecular testing from the patient specimen vial before processing on the ThinPrep System should facilitate broader application of these molecular tests," said Patrick J. Sullivan, Cytyc's chairman, president, and chief executive officer.

Cytyc Corporation is a leading women's health company that designs, develops, manufactures, and markets innovative and clinically effective products. Cytyc products cover a range of women's health applications, including cervical cancer screening, breast cancer risk assessment, treatment of excessive menstrual bleeding, and treatment of breast cancer.

Cytyc is traded on The Nasdaq Stock Market under the symbol CYTC. Cytyc, PreservCyt, 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 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, customers and proprietary technology, uncertainty of product development efforts and product acceptance, management of growth and product diversification, entry into new market segments, 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, 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 "Certain Factors Which May Affect Future Results" in its 2004 Annual Report on Form 10-K and its most recent Quarterly Report on Form 10-Q 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.

Source: Business Wire

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