Studies reinforce value of the ThinPrep Imaging System over manual screening
BEDFORD, Mass. (November 16, 2007) - Hologic, Inc. (NASDAQ: HOLX), a diversified diagnostic and medical product and device company dedicated to serving the healthcare needs of women, today announced that twenty-two scientific abstracts evaluating the performance of the ThinPrep® System were presented this week at the 55th Annual Scientific Meeting of the American Society of Cytopathology (ASC) in Houston, Texas. Eleven of these studies featured the ThinPrep® Imaging System and
evaluated a number of screening parameters including disease detection compared to manual screening of ThinPrep Pap Tests, detection of glandular abnormalities, and impact on overall quality and productivity.
A study conducted at Brooke Army Medical Center, by Duby et al., compared 54,093 manually screened ThinPrep Pap Tests and 53,209 cases evaluated using the ThinPrep Imaging System. The author reported that, "Implementation of the ThinPrep Imaging System has improved detection rates for both squamous intraepithelial lesions (SIL) and malignancies, in addition to lowering the rate of unsatisfactory Pap tests."
A study by Volmar et al., conducted at UNC-Chapel Hill, North Carolina reported on the impact of the ThinPrep Imaging System in a medium volume academic medical practice. The authors reported that, "Implementation of the ThinPrep Imaging System led to an increase in the detection of all classes of abnormalities, with a particular increase in atypical squamous cells - cannot exclude high grade (ASC-H), high grade squamous intraepithelial lesions (HSIL), and cancers."
A study conducted at Magee-Womens Hospital of University of Pittsburgh Medical Center by Flanagan et al., reported on the detection rates of cervical epithelial cell abnormalities before and after implementation of the ThinPrep Imaging System. The result showed that with implementation of the ThinPrep Imaging System there was an increase in detection of total abnormalities. The authors concluded, "Assuming approximately 100,000 liquid-based cytology Paps performed per year, up to an
additional 2,609 abnormalities have been detected."
A study by Hannah et al., from Central Coast Pathology Consultants, San Luis Obispo, California, evaluated results of 27,098 slides processed with the ThinPrep Imaging System compared to 24,129 slides processed with the Becton, Dickinson and Company (Surepath) FocalPoint™ Slide Profiler Pap imaging system. The authors concluded that, "the ThinPrep Imaging System detects a higher percentage of atypical squamous cells of undetermined significance (ASCUS), atypical squamous cells - cannot
exclude high grade (ASCUS-HG), and low grade squamous intraepithelial lesions (LSIL) than does the SurePath Focal Point computer-assisted screening system without an increased percentage of unsatisfactory specimens."
"These data continue to reinforce the clinical benefits and value of the ThinPrep Imaging System over manual screening of the ThinPrep Pap Tests and other cervical screening methods," said Ellen Sheets, M.D., Hologic's chief medical officer. "We are gratified that our customers are realizing these benefits in their daily practices and continuing to share their data at these important scientific meetings."
The abstracts of all studies presented at the 55th ASC Annual Scientific Meeting were published in the Cancer Cytopathology, October 25, 2007 Supplement.
About Hologic, Inc.
Hologic, Inc. is a diversified diagnostic and medical product and device company dedicated to serving the healthcare needs of women. Historically, we have developed, manufactured and marketed products focused on mammography, breast care and osteoporosis assessment. In October 2007, we completed our business combination with Cytyc Corporation, a company that develops, manufactures and markets a complementary product line covering a range of cancer and women's health applications, including
cervical cancer screening, treatment of excessive menstrual bleeding, and radiation treatment of early-stage breast cancer. As a result of our business combination with Cytyc, we have become one of the largest companies in the world focused on creating innovative and clinically effective advanced technologies in women's health. For more information visit
www.hologic.com
Hologic and ThinPrep are registered trademarks of Hologic, Inc. FocalPoint is a trademark of Becton, Dickinson and Company.
Forward Looking Disclaimer
This release contains forward-looking information that involves risks and uncertainties, including statements regarding the performance and clinical benefits of Hologic's ThinPrep Imaging System and related products, Hologic's plans, objectives, expectations and intentions. Such statements include, without limitation, statements regarding the benefits and performance of Hologic's ThinPrep Imaging System. These forward-looking statements are subject to known and unknown risks and
uncertainties that could cause actual results to differ materially from those anticipated. Factors that could cause actual results to materially differ include, without limitation, the risk that Hologic's products may contain defects or otherwise not perform as anticipated; the early stage of market development for certain of the Company's products; technical innovations that could render products marketed or under development by Hologic obsolete and competition. Other factors that could
adversely affect Hologic's business and prospects are described in Hologic's filings with the Securities and Exchange Commission. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in Hologic's expectations or any change in events, conditions or circumstances on which any such statement is based.
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