Volumetric Breast Density Assessment Tool Developed for Digital Mammography

It creates an internal three-dimensional (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.

Hologic, Inc. (Bedford, MA, USA), a leading developer, manufacturer, and supplier of diagnostics, medical imaging systems, and surgical products announced that it has received U.S. Food and Drug Administration (FDA) clearance for the R2 Quantra volumetric breast density assessment tool.

Using the Quantra tool to provide numeric values for each breast may help radiologists in the evaluation of breast tissue composition without the subjectivity of human interpretation. Based on previous research, new models for predicting a woman's risk of developing breast cancer find that breast density is clinically a highly significant predictor of breast cancer risk, a factor almost as powerful 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.”

FDA clearance of the R2 Quantra volumetric breast density-assessment application was received in September 2008. The product is expected to be available in the U.S. market in October 2008.

Hologic's core business units are focused on breast health, diagnostics, gynecologic-surgical, and skeletal health. Hologic provides a range 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, mini C-arm for extremity imaging, and molecular diagnostic products including reagents for a variety of DNA and RNA analysis applications.

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