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Medical Associations and Advocacy Groups Acknowledge Importance of New FDA Claims for ThinPrep(R) Pap Test
MARLBOROUGH, Mass., (Sep 15, 2005) - Cytyc Corporation, a leading women's health company, today announced that a number of medical associations and women's health advocacy groups have issued statements acknowledging the importance of the ability of the ThinPrep(R) Pap Test to better detect glandular lesions. Cytyc announced last week that the U.S. Food and Drug Administration (FDA) has approved a Pre-Market Approval Supplement for the ThinPrep Pap Test related to the detection of endocervical and endometrial glandular lesions. The enhanced labeling cites multiple peer-reviewed publications that report on the improved ability of the ThinPrep(R) System to detect glandular disease versus the conventional Pap smear. The comments come from a broad range of organizations representing health care professionals and patient advocacy groups. In a statement posted September 9, 2005, the Society of Gynecologic Oncologists (SGO) "notes with interest a recent regulatory approval that could result in improved detection of abnormal glandular lesions of the cervix. This is significant because although glandular cell types comprise less than 20 percent of all cervical cancers, glandular abnormalities have been responsible for the majority of the increases in cervical cancer among women under age 35. Specifically, the FDA recently approved a labeling change for the liquid-based cytology test, ThinPrep Pap Test, as a result of evidence that this technology produces more reliable results in detecting abnormalities of glandular cells. These abnormalities are sometimes missed 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 the health professional and women's health communities in educating health care providers and the public about the improved ability of the ThinPrep Pap Test to detect glandular cervical lesions." The American Medical Women's Association (AMWA) executive director, Linda Hallman, issued a statement that "recognizes the importance of improving glandular cervical cancer lesion detection." Ms. Hallman added, "AMWA has been very concerned about the rise of cervical adenocarcinoma, particularly in young women." The Black Women's Health Imperative issued a statement applauding the recent FDA approval of expanded glandular claims for the ThinPrep Pap Test and noted that the "improved detection capability is an important advancement in the fight against cervical cancer" and added they will publicize this important cervical cancer improvement. The statement emphasized the importance "for women, and particularly for African-American and other underserved women, to have access to the most accurate Pap test available." The National Family Planning & Reproductive Health Association (NFPRHA) announced that it "welcomes the addition of a new labeling claim that acknowledges the improved ability of the ThinPrep Pap Test to detect glandular disease versus the conventional Pap smear." NFPRHA added it "is alarmed by the increasing incidence of glandular disease, particularly of women of reproductive age who comprise the majority of Title X patients." In addition, the Gynecologic Cancer Foundation (GCF) commented on the new FDA glandular claim for the ThinPrep Pap Test noting "evidence showing that Pap tests collected using ThinPrep technology are more reliable in detecting abnormalities arising from the mucous secreting gland cells of the cervix; a part of the cervix that has sometimes been missed by conventional Pap test methods." The comments are included in "A Letter to Women of America" from GCF chairman Karl Podratz, M.D., Ph.D., that is part of the GCF 2005 State of the State of Gynecologic Cancers. "The immediate positive response to our recent announcement of expanded labeling for the ThinPrep Pap Test related to glandular disease from such a wide and diverse group of organizations on the frontlines of women's health confirms the significance of this important development," said Patrick J. Sullivan, Cytyc's chairman, president, and chief executive officer. "We are very proud of the unique benefits that the ThinPrep Pap Test has contributed to advance women's health and we will continue to work with our partners to improve women's lives." About HologicHologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic and medical imaging systems dedicated to serving the healthcare needs of women, and a leading developer of innovative imaging technology for digital radiography and breast imaging. Hologic’s core business units are focused on mammography and breast biopsy, osteoporosis assessment, and mini C-arm and extremity MRI imaging for orthopedic applications. Cytyc’s products cover a range of cancer and women’s health applications, including cervical cancer screening, preterm birth screening, treatment of excessive menstrual bleeding, radiation treatment of patients with early-stage breast cancer. Forward-looking statements 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.
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