News | September 30, 2008

Hologic Receives 510(k) for Breast Density Assessment Tool

September 30, 2008 - Hologic Inc. received FDA 510(k) clearance for the R2 Quantra volumetric breast density assessment tool, a software application for use with Hologic digital mammography systems as an automated method for assessing breast density.
It creates an internal 3D model of the breast from which it derives estimates of the fibroglandular tissue volume and total breast volume; volumetric breast density is the ratio of these values. Using the Quantra tool to provide numeric values for each breast may aid radiologists in the assessment of breast tissue composition without the subjectivity of human interpretation.
According to research published in Journal of the National Cancer Institute, new models for predicting a woman’s risk of developing breast cancer find that breast density is a highly clinically significant predictor of breast cancer risk that is almost as powerful a risk factor as age. Prior to the development of Quantra software, there has not been a consistent breast density assessment method available to clinicians.
“The recent FDA clearance of the Quantra breast density assessment application provides radiologists with a clinical tool to assess breast density and should facilitate better breast cancer risk assessment models for the future,” said Dr. Ronald A. Castellino, Chief Medical Officer for Hologic. “Current clinical breast density assessment methods do not offer a consistent way to assign breast density categories as they tend to focus on human observations of density, rather than numeric measures of density. The Quantra tool should provide researchers with the information they need to conduct further research on breast density’s true relationship with breast cancer.”
The R2 Quantra volumetric breast density assessment application will be available in the U.S. market in October 2008.

For more information: www.hologic.com

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