Study to evaluate sensitivity of mammography combined with somo•v ABUS technology in breast cancer screening

Henry Ford West Bloomfield Hospital announced today that it has joined U-Systems national clinical research study designed to evaluate whether digital mammography, when combined with the somo•v™ Automated Breast Ultrasound System (ABUS) from U-Systems, Inc (Sunnyvale, CA), is more sensitive in detecting breast lesions compared to mammography alone in women with dense breasts. Henry Ford West Bloomfield Hospital is the only site in Michigan, and one of only ten breast cancer centers in the entire country, currently recruiting women for the SOMO•INSIGHT clinical study.

“While mammography remains the gold standard, visualization of cancers in dense breast tissue with mammography can be limited in some women”

"While mammography remains the gold standard, visualization of cancers in dense breast tissue with mammography can be limited in some women," says Henry Ford radiologist Biren A. Shah, M.D., who is principal investigator for the SOMO•INSIGHT Clinical Study at Henry Ford West Bloomfield Hospital. "It is exciting to participate in this study designed to determine if somo•v Automated Breast Ultrasound can identify breast cancers not seen with digital mammography alone, in women with dense breasts. We believe if this study is successful, it will be a tremendous technological advancement in early breast cancer detection, especially for the high risk group of women with dense breasts."

The SOMO•INSIGHT multi-center study will enroll up to 20,000 women at clinical study sites in the United States to determine the sensitivity of mammography and somo•v together, compared to mammography alone for women with greater than fifty percent dense breast tissue.

Ron Ho, President and CEO of U-Systems said, "We are honored to partner with Dr. Shah and Henry Ford West Bloomfield Hospital for the SOMO•INSIGHT Clinical Study as we believe that somo•v ABUS technology will play a vital role in significantly advancing breast cancer screening."

Unlike mammography, which uses radiation to identify breast cancer lesions, somo•v ABUS technology uses sound waves at a safe frequency to create images of the breast tissue. Ultrasound has been shown to find cancer that may not be visible with mammography alone, in women who have dense breasts.