Volpara breast imaging software receives FDA clearance

Offering radiologists a reliable and cost-effective tool to generate automatic volumetric breast density values, Volpara, Ltd., announced today that it has received clearance from the U.S. 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.

Automatically computing volumetric breast tissue density from screening mammograms, Volpara software assists radiologists by providing objective, automatic and robust measurement of volumetric breast tissue density.  Cleared for use with digital mammography systems, Volpara is currently available for Hologic and GE digital mammography systems with other systems undergoing validation.

Breast tissue density has not only been linked to an increased risk of breast cancer, it also decreases the sensitivity of the mammogram and thereby may impact early detection.  Several large studies have confirmed 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 masks the appearance of tumors (Boyd et al 2007, NEJM).  Since both dense breast tissue and cancer appear white on a mammogram, finding cancers can be analogous to looking for a snowball in a snow storm.

"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.  "Volpara will improve radiologists' understanding of breast composition and assist them in helping patients to make appropriate screening decisions."

Radiologists currently use the Breast Imaging Reporting and Data System (BI-RADS) system to classify density.  Developed by the American College of Radiology, the density assessment ranges from Category 1 (mostly fat) to Category 4 (extremely dense).  However, the density category assessment is subjective and varies widely among interpreting physicians, even those who are experienced.  Automated, objective, volumetric density assessments, consistently applied, has the potential both for establishing a new and important metric 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 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 Centre in Toronto, 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 state-of-the-art algorithm developed by some of the world's top imaging scientists using new developments in imaging physics. The robustness of the software provides quantitative reliability, 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 traditional screening mammography.

"Density has become a breast healthcare issue of increasing importance as Connecticut and at least seven other states have enacted or are considering density notification legislation. This was bolstered recently as Nancy Brinker, founder and CEO of Susan G. Komen for the Cure, expressed Komen's position that it should be regular practice for doctors to inform women of their breast density if their mammogram shows they have dense breast tissue, and that it is important for doctors to discuss with their patients with dense breasts what additional screening tools might be appropriate for them," said Gerald Kolb, vice president of Business Development for Volpara.

SOURCE Volpara, Ltd.