Hologic has received FDA clearance for the R2 Quantra volumetric breast density assessment tool, a software application intended for use with Hologic digital mammography systems that provides radiologists with an automated method for assessing breast density.

"Our research has shown that increased breast density corresponds to an increase in incidence of breast cancer, and it was difficult for radiologists to asses the breast density accurately," product manager Sibel Narin told DOTmed News. "Because of the need for a reliable, consistent measurement application for breast density, Hologic created R2 Quanta."

The software 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.
"Quantra provides valuable information that radiologists use," Narin added. "They had to manually estimate this. Due to shade differences or observer differences, one radiologist may assess things differently, and it was less consistent. Quantra provides reliable breast tissue quantitative assessment."

According to research published in the 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."

Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women.

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

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