Targeted Strategies for Today's Evolving Markets

MissionIR Blog

Hologic, Inc. (HOLX) Receives FDA Clearance to Incorporate World Health Organization 10-Year Fracture Risk Assessment into Its Bone Densitometer Systems

Hologic, Inc. (HOLX) is a developer, manufacturer and supplier of 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. The company, in June, announced the acquisition of Third Wave Technologies, which develops and markets molecular diagnostic reagents for a wide variety of DNA and RNA analysis applications based on its proprietary Invader® chemistry.

Hologic recently announced that it 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, U.K., 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 built this technology into its Discovery™ and Explorer™ bone densitometer systems.

FRAX, an algorithm, enables healthcare providers to identify patients with a high risk of experiencing bone fractures within a period of 10 years. Individual countries can determine a country specific intervention threshold, where pharmacological treatment is justified for fracture prevention. FRAX identifies patients who are at high risk of fracture but would not be candidates for preventative therapy. Using the traditional T-score, FRAX combines 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.

Let us hear your thoughts below:

This entry was posted in Small Cap News. Bookmark the permalink.

Leave a Reply

Your email address will not be published. Required fields are marked *