Press release from PR Newswire
Hologic Receives FDA Clearance to Include Advanced Body Composition Assessment in Its Bone Density Systems
Wednesday, April 20, 2011
Hologic Receives FDA Clearance to Include Advanced Body Composition Assessment in Its Bone Density Systems13:30 EDT Wednesday, April 20, 2011Hologic is first to incorporate National Health and Nutrition Examination Survey Whole Body Reference Data into its Discovery line of DXA systemsBEDFORD, Mass., April 20, 2011 /PRNewswire/ -- Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced that it has received U.S. Food and Drug Administration (FDA) clearance to incorporate the U.S. National Health and Nutrition Examination Survey (NHANES) Whole Body Reference Data into its Discovery dual x-ray absorptiometry (DXA) systems. These body composition values are useful to healthcare professionals in their management of diseases and conditions when the disease or condition itself, or its treatment, can affect the relative amounts of fat and lean tissue.To view the multimedia assets associated with this release, please click: http://multivu.prnewswire.com/mnr/hologic/39366/(Photo: http://photos.prnewswire.com/prnh/20110420/MM81286 )The prevalence of obesity has reached pandemic proportions. Globally, 1.5 billion adults, 20 years old and older, were overweight in 2008 and 65 percent of the world's population live in countries where the number of obese and overweight people now exceeds the underfed.(1) According to the U.S. Centers for Disease Control and Prevention (CDC) approximately 72.5 million adults in the United States were considered obese in 2007-2008, increasing their risk for coronary heart disease, hypertension, stroke, type 2 diabetes, certain types of cancer, and premature death.(2) Unfortunately, children are not immune to this disease. It is estimated that 17 percent of American children and adolescents ages 2-19 years old are obese, according to the latest NHANES.(3)The FDA clearance of the Hologic Advanced Body Composition Assessment package opens up a new market for the Hologic Discovery whole body DXA systems which, up to now, have primarily been used to measure osteoporosis in women after they reach menopause."Body mass measurement on our Discovery systems is another significant milestone for Hologic and our skeletal health business," said John Jenkins, Vice President and General Manager of the Hologic Skeletal Health business. "Our new Advanced Body Composition assessment package provides a more detailed and more consistent baseline for measuring body mass changes than bio-impedance testing, hydrostatic weighing and skin fold thickness. This new indication is a major step forward in helping maintain the quality of life of men and women and, we hope, will become the standard of care for adults and children."About Advanced Body Composition AssessmentThe Hologic Advanced Body Composition assessment package is designed to provide a quick, accurate and precise low-dose x-ray exam to aid the physician in the assessment of fat, lean tissue and bone. Some of the diseases and conditions for which body composition values are useful include chronic renal failure, anorexia nervosa, obesity, AIDS/HlV, and cystic fibrosis. A whole body composition scan can take as little as three minutes. During the exam, the patient lies comfortably on a padded table while the Discovery system scans the body. Unlike typical x-ray machines, radiation exposure during this exam is extremely low and involves no injections, invasive procedures or pain. Hologic's new assessment package includes color images displaying the distribution of fat, lean tissue, and bone and an easy to interpret report for improved patient management and counseling. About Hologic, Inc.Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic's core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, breast magnetic resonance imaging, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia and uterine fibroids, permanent contraception, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging and molecular diagnostic products including HPV and reagents for a variety of DNA and RNA analysis applications.Forward Looking Statement DisclaimerThis News Release may contain forward-looking information that involves risks and uncertainties, including statements about the use of the Discovery bone density system. There can be no assurance the system will achieve the benefits described herein and that such benefits will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of the Discovery bone density system can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in the Company's expectations or any change in events, conditions or circumstances on which any such data or statements are based.Hologic, Advanced Body Composition and Discovery are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.(1) World Health Organization Obesity and Overweight Fact sheet N 311 http://www.who.int/mediacentre/factsheets/fs311/en/ (2) Vital Signs: State-Specific Obesity Prevalence Among Adults --- United States, 2009 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm59e0803a1.htm (3) National Health and Nutrition Examination Survey (NHANES) http://www.cdc.gov/obesity/childhood/index.html Contact:Olga KaragiannisAnne RiversSenior Global Advertising and Publicity SpecialistManager, Corporate ProjectsHologic, Inc.Hologic, Inc. Tel: +1.781.761.7069Tel: +1.508.263.8765SOURCE Hologic, Inc.