U-Systems announces significant upgrade for somo•v ABUS at RSNA 2009

U-Systems, Inc., the leader in developing automated breast ultrasound systems, announced a significant upgrade for its somo•v™ Automated Breast Ultrasound System (ABUS) here at the 95^th Annual Meeting of the Radiology Society of North America. The INSIGHT Class release incorporates a series of image quality and analysis enhancements designed to better visualize and differentiate complex breast tissue and enable fast and accurate image review. These enhancements were designed and developed to provide the foundation functionality for U-Systems’ ground-breaking, prospective SOMO•INSIGHT study, a nationwide multi-center clinical study designed to evaluate whether digital mammography in combination with the somo•v ABUS is more sensitive to detecting breast lesions when compared to digital mammography alone in women with dense breasts. The SOMO•INSIGHT study is notable in its scope and potential impact on women’s health.

“Ultrasound is an effective adjunct to mammography especially for women with dense breasts who as a group, have a 4-6 times greater risk of breast cancer,” said Rachel Brem, MD, principal investigator for the SOMO•INSIGHT clinical study at The George Washington University Medical Center. “The somo•v ™ Automated Breast Ultrasound System (ABUS) is a robust ultrasound technology that allows for additional evaluation of women in whom mammography may be more challenging.

“SOMO•INSIGHT is a pivotal study, designed to evaluate the sensitivity of mammography and somo•v ABUS together, as compared to mammography alone in women with dense breasts. We are excited to participate in this important study evaluating potential new approaches to the early detection of breast cancer. This scientifically rigorous study will evaluate over 20,000 women to determine the incremental increase in cancer detection with automated whole breast ultrasound in women with dense breasts,” Dr Brem added.

Studies show that approximately 35 percent of breast cancer goes undetected by mammography in women with dense breasts. This multi-center study, which intends to recruit over 20,000 women, is an important milestone in evaluating new approaches to improved cancer detection in this population. ABUS uses ultrasound (sound waves) at a safe frequency to create images of the breast tissue, unlike mammography, which uses radiation. Ultrasound has been shown to find cancer not visible with mammography in women who have dense breasts.

“We are working with 12 dedicated breast imaging centers across the country in this landmark study with more to be added as we progress,” said Ronald Ho, president and CEO of U-Systems. “More than 2,000 asymptomatic women meeting the eligibility requirements have been enrolled, thus far, with the remainder expected to be enrolled through 2010. To date, the SOMO·INSIGHT study has resulted in the detection of cancers previously undetected by mammography. The data analysis from the SOMO•INSIGHT study may provide the scientific foundation for the establishment of the standard for ultrasound breast cancer screening.”

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