FDA Approves Ultrasound Tool

The U.S. Food and Drug Administration (FDA) has approved a new adjunct screening tool to be combined with mammography for asymptomatic women with dense breast tissue who have not had prior clinical breast intervention.

About 40% of women who are screened by mammography have dense breast tissue. These women have a higher proportion of dense fibro-glandular tissue, which can obscure smaller tumors, and mammography fails to detect about 35% of their breast cancers. Although a recent paper (J Natl Cancer Inst 2012;104:1218–27) indicates that high breast density does not increase risk of death from breast cancer in women once diagnosed, it has been associated with an increased risk of developing the disease.

The somo-v Automated Breast Ultrasound System (ABUS) from U-Systems of Sunnyvale, CA, was initially approved in a premarket notification program in 2005 for adjunct diagnostic purposes, which involves the assessment of tumors already identified or suspected.

The FDA's new approval for its use as a screening tool was based on a clinical reader study in which radiologists looked at 200 cases of asymptomatic women with dense breast tissue from a prospective multicenter registry. The study found that using somo-v ABUS in addition to mammography improved the detection of cancerous tumors by about 30% compared to mammography alone.

“What was very exciting in this reader study was that a majority of the cancers, which had not been seen on the screening mammograms during the prospective registry study, were invasive cancers that had not spread to the lymph nodes,” says Maryellen Giger, PhD, principal investigator of the study and professor of radiology at the University of Chicago. “If we were to wait for these to grow and become visible on a mammogram, there's the chance the cancers would become lymph node positive.”

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