Clinical study to evaluate potential new approaches for early detection of breast cancer

U-Systems announced today that Community Hospital of the Monterey Peninsula’s Breast Care Center has initiated participation in the SOMO·INSIGHT Clinical Study. The first breast center in California to participate, Community Hospital is recruiting participants for the national clinical study designed to evaluate whether digital mammography in combination with the somo•v Automated Breast Ultrasound System (ABUS) from U-Systems is more sensitive to detecting breast lesions when compared to mammography alone in women with dense breasts.

“We are pleased to take part in this important study evaluating potential new approaches to the early detection of breast cancer, particularly in women with dense breasts, which historically have been difficult to screen,” said Susan G. Roux, M.D., medical director of the Breast Care Center and principal investigator for the SOMO·INSIGHT clinical study at Community Hospital. “Despite recent criticism of screening, we strongly believe that early detection is critical and we are gratified to be able to provide women in the Monterey Peninsula area with access to a technology that could potentially detect tumors earlier in the fight against breast cancer.”

The initiation of this multi-center study, which intends to recruit over 20,000 women, is an important milestone for U-Systems in evaluating new approaches to improved cancer detection. Screening mammography can be limited in women with dense breasts and these women may have a higher risk of breast cancer. 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. A new approach to improving breast cancer detection is critical for women with dense breasts who undergo mammography. It is for this reason that U-Systems developed the somo•v and is sponsoring the SOMO·INSIGHT clinical study.

“We are very excited to be initiating the SOMO·INSIGHT Clinical Study with Dr. Roux and Community Hospital of the Monterey Peninsula,” said Ron Ho, president and CEO of U-Systems. “We believe that somo•v™ ABUS technology will play a vital role in significantly advancing breast cancer screening in the community hospital setting. The use of the somo•v™ ABUS in combination with mammography may aid the physician in earlier detection of breast cancer for this large group of asymptomatic women with increased breast density.”