Study Shows Advantage of Delphinus Medical’s SoftVue UST in Breast Cancer Detection

Delphinus Medical Technologies Inc.’s SoftVue Breast Ultrasound Tomography (UST) is better than mammography alone in detecting cancer in women with dense breasts, a new study has concluded. 

Among 140 cases included in the multi-reader, multi-case study, mammogram plus SoftVue UST demonstrated superiority in cancer detection compared to mammography alone. Thirty-two Mammography Quality Standards Act-qualified radiologists from academic, private, and community-based practices in diverse areas participated in the study. For each case, readers independently evaluated the mammogram and assigned a Breast Imaging Reporting and Data System (BI-RADS) score. They then assessed the mammogram plus UST for the same case and assigned a separate BIRADS assessment.

• Adding SoftVue UST to screening mammography showed statistical superiority in the performance of breast cancer detection in women with dense breasts compared with mammography alone.
• Adding SoftVue UST to screening mammography led to a statistically significant 25% improvement in sensitivity for breast cancer detection of BI-RADS 4 or higher lesions compared with mammography alone.
• Adding SoftVue UST to screening mammography led to a statistically significant 8% improvement in specificity for BI-RADS 3 lesions compared with mammography alone.

“SoftVue provides a unique solution that has been missing in dense breast screening. As a breast imager it is exciting to see a screening technology that not only increases cancer detection, but also allows us to reduce the number of short-term follow-ups. This means more women who have breast cancer will be referred for biopsy immediately and more women without breast cancer will be reassured they do not need follow-up,” Delphinius Medical Technologies Medical Director Dr. Elise Berman stated.

Breast cancer screening with mammography reduces mortality by 41% in women with non-dense breasts but reduces mortality by only 13% in women with dense breasts. The U.S. government has also reinforced the importance of supplemental screening by mandating federal breast density notifications to be sent to each affected patient, effective in September this year.

SoftVue UST paired with mammography provides a new annual screening solution for women with dense breasts and is the only ultrasound-based breast imaging system that is U.S. Food and Drug Administration-approved for same-day screening as mammography.

Headquartered in Novi, Mich., Delphinus Medical Technologies Inc., developed SoftVue, featuring the first circular array transducer technology. The patented technology is a 3D whole-breast ultrasound tomography system that delivers no radiation, requires no compression, and images the entire breast with a single scan.