BEDFORD, Mass. Hologic, Inc. is the first diagnostic medical device manufacturer to receive U.S. Food and Drug Administration clearance to incorporate the World Health Organization (WHO) FRAX™ 10-year fracture risk calculator into its bone densitometer systems.

The WHO Collaborating Centre for Metabolic Bone Diseases, located at the University of Sheffield Medical School, UK, under the leadership of Prof. John Kanis developed FRAX as a tool to help healthcare providers identify and proactively treat patients with a high risk of bone fractures due to low bone mass and other risk factors. Hologic, a leading provider of state-of-the-art diagnostic and digital imaging systems directed towards women's health, has built this breakthrough technology into its Discovery™ and Explorer™ bone densitometer systems.

While the T-score remains the standard for diagnosing osteoporosis, FRAX breaks new ground enabling healthcare providers to identify patients with a high risk of experiencing bone fractures within a period of 10 years. By combining eleven of the highest risk factors, including age, personal history of fractures, and family history of fractures, plus country-specific life expectancy and country-specific fracture data, FRAX identifies patients who are at high risk of fracture but would not be candidates for preventative therapy using the traditional T-score.

"The prompt integration of the FRAX calculator into our products exemplifies Hologic's on-going commitment to provide the most up-to-date technology combating osteoporosis, a critical women's health issue," said Kevin Wilson, PhD, Scientific Director at Hologic. "By incorporating the FRAX calculator into our bone densitometer systems, we dramatically alter and improve the way patients are evaluated and treated for potential bone fractures. In the United States, the National Osteoporosis Foundation in collaboration with many other physician groups has issued guidelines recommending that a patient's 10-year fracture risk calculated with FRAX be used by physicians to determine whether pharmacological treatment is indicated for prevention of bone fractures.1"

1 Clinician's Guide to Prevention and Treatment of Osteoporosis 2008, National Osteoporosis Foundation. Available at www.nof.org.

FRAX is a trademark of the World Health Organization Collaborating Centre for Metabolic Bone Diseases, located at the University of Sheffield Medical School, UK.

About Hologic

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, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia, osteoporosis assessment, preterm birth risk assessment, and mini C-arm for extremity imaging.
FAQs

Q. What Is FRAX™
A. FRAX is an algorithm developed by the World Health Organization Collaborating Centre for Metabolic Bone Diseases, located at the University of Sheffield Medical School, UK that calculates a ten-year fracture probability as a percentage. Individual countries can then determine a country specific intervention threshold, where pharmacological treatment is justified for fracture prevention. In the United States, the National Osteoporosis Foundation, in collaboration with other physician organizations has recommended intervention thresholds for postmenopausal women and men over the age of 50.

Q. How is FRAX calculated?
A.FRAX is based on individual patient models that integrate the risks associated with clinical risk factors as well as bone mineral density (BMD) at the femoral neck to calculate a patients 10-year fracture risk.1 The FRAX tool combines eleven risk factors such as age, sex, ethnicity, BMI, prior fracture, parental history of hip fracture, smoking, rheumatoid arthritis, other causes of secondary osteoporosis and daily alcohol consumption

Q. Does FRAX replace the T-score?
A. No, the T-score remains a critical diagnostic tool and the diagnostic threshold is unchanged at T-score = -2.5

FRAX represents a major breakthrough in early intervention to prevent bone fractures. It identifies patients who have a high risk of experiencing fractures over a period of ten years but who have not yet crossed the diagnostic threshold for osteoporosis.

Q. How Was FRAX Developed?
A. The FRAX model has been developed from studying population-based cohorts in Europe, North America, Asia, and Australia. The FRAX algorithms give the 10-year probability of hip fracture and the 10-year probability of a major osteoporotic fracture, (clinical spine, forearm, hip or shoulder fracture)1

Q. Will the FRAX tool be available for existing Discovery and Explorer bone densitometer systems?
A. Yes, upgrades are available for installed Discovery and Explorer systems.
For additional information:

International Osteoporosis Foundation: http://www.iofbonehealth.org/
National Osteoporosis Foundation: http://www.nof.org/
WHO Collaborating Centre for Metabolic Bone Diseases, located at the University of Sheffield Medical School, UK : http://www.shef.ac.uk/FRAX/