Pivotal Study Supports Use of Automated Breast Ultrasound for Cancer Screening

A multireader, multicase (MRMC) ROC (receiver operating characteristic) reader study was performed to evaluate the sensitivity of automated breast ultrasound (ABUS) together with a screening mammograms in detecting breast cancer in women with dense breast tissue.

U-Systems, Inc. (Sunnyvale, CA, USA), a developer of automated breast ultrasound, announced the completion of the pivotal ROC Reader Study for ABUS, which was conducted by radiologists from the University of Chicago (IL, USA). "For most women, mammography remains the gold standard for the early detection of breast cancer, but multiple studies have demonstrated that it is not enough for women with dense breast tissue," said study lead investigator Maryellen Giger, PhD, professor of radiology at the University of Chicago. "The primary objective of this reader study was to determine the impact of ABUS on Reader [interpreting physician] performance when used in combination with mammography as a screening modality for asymptomatic women with dense breast tissue. This study brings us one step closer to earlier detection of breast cancer using ultrasound as an adjunctive screening tool."

"The reader study data will provide the scientific and statistical foundation to validate the efficacy of our ABUS technology and will be used as the basis for our Pre-Market Application [PMA] submission to the US Food & Drug Administration," said Ron Ho, president and CEO of U-Systems.

Successful completion of this key milestone keeps U-Systems on schedule for an FDA submission in which the company will seek a new indication for the use of somo•v ABUS for use in screening women with dense breast tissue. The somo•v is currently FDA 510(k)-cleared for adjunctive diagnostic use with mammography.

The Reader Study cases were collected under the SOMO•INSIGHT Clinical Study, which is the largest prospective clinical trial ever undertaken by an ultrasound company. The SOMO•INSIGHT Clinical Study was, designed to evaluate whether digital mammography in combination with somo•v ABUS is more sensitive than a routine screening mammogram alone in detecting breast cancer in women with dense breast tissue. To date, more than 12,000 women have participated in the study, which is actively recruiting up to 20,000 women at multiple breast imaging centers. To date, the study has identified a significant number of mammographically negative breast cancers that were subsequently detected by ABUS.

"While ultrasound is a proven tool throughout the diagnosis and treatment of breast cancer, it has not typically been 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%," added Mr. Ho. "New approaches to improve early detection in women with dense breasts are clearly needed. We have dedicated significant time and resources to establishing a solid scientific basis for the use of ABUS as a cancer screening tool for women with dense breast tissue."

A growing body of research demonstrates a strong link between breast density and increased cancer risk--up to four to six times in one study. The research showed 35% of breast cancer goes undetected by mammography in women with dense breasts as density masks the appearance of tumors. Since both dense breast tissue and cancer appear white on a mammogram, it is difficult to detect cancer when there is increased dense breast tissue. As breast density increases, the accuracy of the mammogram decreases.

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