29.09.2005 13:12:00
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Cytyc Receives Expanded Labeling to Facilitate Molecular Testing with the ThinPrep(R) Pap Test
"The testing of the residual specimen in the PreservCyt samplevial for Chlamydia trachomatis, Neisseria gonorrheae and HPV iscurrently conducted in many laboratories based on FDA approvalspreviously granted to Cytyc. The ability to remove an aliquot beforepreparing the ThinPrep Pap Test slide greatly improves theimplementation of amplified molecular testing, particularly inhigh-volume laboratories," said James Linder, M.D., Cytyc's chiefmedical officer.
"We are extremely pleased to provide this capability to ourcustomers. The ThinPrep Pap Test is the only liquid-based cytologymethod to have FDA approval for specific molecular diagnostic tests.Our ThinPrep Pap Test collection vial serves as a platform, enablingThinPrep plus Imaging and testing for important sexually transmittedinfections from a single patient specimen. This newly approvedcapability to remove a sample for molecular testing from the patientspecimen vial before processing on the ThinPrep System shouldfacilitate broader application of these molecular tests," said PatrickJ. Sullivan, Cytyc's chairman, president, and chief executive officer.
Cytyc Corporation is a leading women's health company thatdesigns, develops, manufactures, and markets innovative and clinicallyeffective products. Cytyc products cover a range of women's healthapplications, including cervical cancer screening, breast cancer riskassessment, treatment of excessive menstrual bleeding, and treatmentof breast cancer.
Cytyc is traded on The Nasdaq Stock Market under the symbol CYTC.Cytyc, PreservCyt, and ThinPrep are registered trademarks of CytycCorporation.
Forward-looking statements in this press release are made pursuantto the provisions of Section 21E of the Securities Exchange Act of1934. Investors are cautioned that statements in this press releasewhich are not strictly historical statements, including, withoutlimitation, statements relating to Cytyc's future financial condition,operating results and economic performance, and management'sexpectations regarding key customer relationships, future growthopportunities, product acceptance and business strategy, constituteforward-looking statements. These statements are based on currentexpectations, forecasts and assumptions that are subject to risks anduncertainties, which could cause actual outcomes and results to differmaterially from those statements. Risks and uncertainties include,among others, dependence on key personnel, customers and proprietarytechnology, uncertainty of product development efforts and productacceptance, management of growth and product diversification, entryinto new market segments, risks associated with litigation, theeffective integration of acquired businesses and technologies,competition and competitive pricing pressures, risks associated withthe FDA regulatory approval processes and healthcare reimbursementpolicies, introduction of technologies that are disruptive to Cytyc'sbusiness and operations, the impact of new accounting requirements andgovernmental rules and regulations, as well as other risks detailed inCytyc's filings with the Securities and Exchange Commission, includingunder the heading "Certain Factors Which May Affect Future Results" inits 2004 Annual Report on Form 10-K and its most recent QuarterlyReport on Form 10-Q filed with the Commission. Cytyc cautions readersnot to place undue reliance on any such forward-looking statements,which speak only as of the date they were made. Cytyc disclaims anyobligation to publicly update or revise any such statements to reflectany change in its expectations or events, conditions, or circumstanceson which any such statements may be based, or that may affect thelikelihood that actual results will differ from those set forth in theforward-looking statements.
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