Over 20 Total Lots Up For Auction at One Location - TX Cleansweep 06/25

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

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?