Hologic, Inc. Receives U.S. FDA Clearance to Incorporate WHO FRAX 10-Year Fracture Risk Calculator Into Bone Densitometer System
by
Joan Trombetti, Writer | September 09, 2008
An algorithm developed
by the WHO Collaborating Centre
for Metabolic Bone Diseases
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.
