S&P 400 MidCap
15.09.2005 13:24:00
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Medical Associations and Advocacy Groups Acknowledge Importance of New FDA Claims for ThinPrep(R) Pap Test
In a statement posted September 9, 2005, the Society ofGynecologic Oncologists (SGO) "notes with interest a recent regulatoryapproval that could result in improved detection of abnormal glandularlesions of the cervix. This is significant because although glandularcell types comprise less than 20 percent of all cervical cancers,glandular abnormalities have been responsible for the majority of theincreases in cervical cancer among women under age 35.
Specifically, the FDA recently approved a labeling change for theliquid-based cytology test, ThinPrep Pap Test, as a result of evidencethat this technology produces more reliable results in detectingabnormalities of glandular cells. These abnormalities are sometimesmissed by conventional Pap test methods."
The National Association of Nurse Practitioners in Women's Health(NPWH) noted in a statement it "is pleased to join its partners in thehealth professional and women's health communities in educating healthcare providers and the public about the improved ability of theThinPrep Pap Test to detect glandular cervical lesions."
The American Medical Women's Association (AMWA) executivedirector, Linda Hallman, issued a statement that "recognizes theimportance of improving glandular cervical cancer lesion detection."Ms. Hallman added, "AMWA has been very concerned about the rise ofcervical adenocarcinoma, particularly in young women."
The Black Women's Health Imperative issued a statement applaudingthe recent FDA approval of expanded glandular claims for the ThinPrepPap Test and noted that the "improved detection capability is animportant advancement in the fight against cervical cancer" and addedthey will publicize this important cervical cancer improvement. Thestatement emphasized the importance "for women, and particularly forAfrican-American and other underserved women, to have access to themost accurate Pap test available."
The National Family Planning & Reproductive Health Association(NFPRHA) announced that it "welcomes the addition of a new labelingclaim that acknowledges the improved ability of the ThinPrep Pap Testto detect glandular disease versus the conventional Pap smear." NFPRHAadded it "is alarmed by the increasing incidence of glandular disease,particularly of women of reproductive age who comprise the majority ofTitle X patients."
In addition, the Gynecologic Cancer Foundation (GCF) commented onthe new FDA glandular claim for the ThinPrep Pap Test noting "evidenceshowing that Pap tests collected using ThinPrep technology are morereliable in detecting abnormalities arising from the mucous secretinggland cells of the cervix; a part of the cervix that has sometimesbeen missed by conventional Pap test methods." The comments areincluded in "A Letter to Women of America" from GCF chairman KarlPodratz, M.D., Ph.D., that is part of the GCF 2005 State of the Stateof Gynecologic Cancers.
"The immediate positive response to our recent announcement ofexpanded labeling for the ThinPrep Pap Test related to glandulardisease from such a wide and diverse group of organizations on thefrontlines of women's health confirms the significance of thisimportant development," said Patrick J. Sullivan, Cytyc's chairman,president, and chief executive officer. "We are very proud of theunique benefits that the ThinPrep Pap Test has contributed to advancewomen's health and we will continue to work with our partners toimprove women's lives."
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 and ThinPrep are registered trademarks of Cytyc Corporation.
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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