U-Systems has completed the study evaluating the sensitivity of its somov Automated Breast Ultrasound (ABUS) in detecting breast cancer in women with dense breast tissue.
The study was designed to determine the effect of ABUS on interpreting physician performance when used in combination with mammography as a screening modality for asymptomatic women with dense breast tissue.
The multi-reader, multi-case study, which involved more than 12,000 women, identified a significant number of mammographically negative breast cancers that were subsequently detected by ABUS.
Following the successful completion of the study, the company is planning to seek a new indication for the use of somov ABUS for use in screening women with dense breast tissue.
The somov is currently FDA 510(k)-approved for adjunctive diagnostic use with mammography.
U-Systems CEO Ron Ho said while ultrasound is a proven tool throughout the diagnosis and treatment of breast cancer, it is not typically used during the screening process.
"However, for women with dense breast tissue several large studies have shown that supplementing mammograms with ultrasound can increase detection from 48 to 97 percent," Ho said.