Breast Imaging Software Designed for Automatic Calculation of Volumetric Breast Density

(Wellington, New Zealand) announced that it has received clearance from the US Food & Drug Administration (FDA) for its Volpara breast imaging software. Volpara, a subsidiary of Matakina Technology, Limited of New Zealand, is responsible for commercial operations in the United States.

Cleared for use with digital mammography systems, Volpara is currently available for Hologic (Bedford, MA, USA) and GE Healthcare (Chalfont St. Giles, UK) digital mammography systems with other systems undergoing validation.

Breast tissue density has not only been associated with an increased risk of breast cancer, it also decreases the sensitivity of the mammogram and thereby may affect early detection. Several large studies have validated that as tissue density increases the accuracy of mammography decreases. Thirty-five percent of breast cancer goes undetected by mammography in women with dense breasts, as density camouflages the appearance of tumors, according to a study published 2007 in the New England Journal of Medicine (NEJM). Since both dense breast tissue and tumors appear white on a mammogram, detecting tumors can be similar to looking for a snowball in a snowstorm.

"Radiologists and imaging scientists have known for years the challenges that tissue density presents to mammography, but there haven't been the means to objectively and automatically quantify the actual amount of breast density from the screening mammogram,” said Dr. Ralph Highnam, CEO, Volpara, Ltd. Radiologists currently use the Breast Imaging Reporting and Data System (BI-RADS) system to classify density. Developed by the American College of Radiology (Reston, VA, USA), the density assessment ranges from category 1 (mostly fat) to category 4 (extremely dense). However, the density category assessment is subjective and varies greatly among interpreting physicians, even those who are experienced. Automated, objective, volumetric density assessments, consistently applied, has the potential both for establishing a new and significant measurement for mammography, and for allowing physicians to compare a patient's volumetric density from year to year.

"With the ability to objectively and accurately measure breast density, we can look at screening women with low and high densities differently rather than one size fits all universal screening programs. For example, it may be a good idea for women with very dense breasts to receive ultrasound or MRI [magnetic resonance imaging] in addition to mammography as part of regular screening. In the future, it may be possible by lowering breast density to reduce breast cancer risk. In this case, it would be helpful to monitor this process by tracking changes in breast density over time. An automated breast density system like Volpara provides quantitative reproducible measurements of breast density and could be useful for both of these purposes,” said Prof. Martin J. Yaffe, PhD, of the Sunnybrook Health Sciences Center (Toronto, Canada) and a renowned physicist responsible for pioneering work on quantitative breast imaging.

Volpara provides an easy to implement, objective volumetric assessment of breast tissue density. Using digital images and information captured in every mammographic exam, the system applies a cutting-edge algorithm developed by some of the world's top imaging scientists using new developments in imaging physics. The software provides quantitative effetiveness, allowing Volpara to be incorporated in both research and with clinical imaging protocols, which are becoming increasingly important as adjuvant imaging is being added to conventional screening mammography.

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