A diagnostic ultrasound scanner designed to work with digital mammography to screen women with dense breast tissue for cancer had been approved by the FDA.
U-Systems in Sunnyvale, Calif, announced that the FDA has granted its premarket approval application for the somo-v Automated Breast Ultrasound System (ABUS) to screen women with dense breast tissue who have had a negative mammogram and show no symptoms of cancer.
"Mammography is an effective tool at finding breast cancer, but it doesn't work equally well in everyone," Rachel Brem, M.D., director of breast imaging at The George Washington University Hospital in Washington, D.C., said in the release. "For the more than 40 percent of women who have dense breasts, this is a significant advancement in their breast healthcare."
"Sometimes the glandular tissue is so dense that radiation doesn't penetrate it. You can't see anything," Robert Smith, senior director of cancer screening at the American Cancer Society said in response to the FDA decision, according to the website areyoudense.org, an organization that raises awareness about dense breast tissue and its significance for the early detection of breast cancer.
Recent studies have demonstrated about a 30 percent increase in the diagnostic yield of breast cancer from the addition of ABUS in women with dense breast tissue who have had a normal mammogram and physical examination, according to Brem.
A multi-center clinical trial evaluating the added efficacy of breast cancer screening of dense breasts performed with ABUS as an adjunct to digital mammography has also been completed, according to U-Systems. More than 15,000 asymptomatic women with dense breast tissue at more than 10 sites were recruited for the study. Published results are expected in 2013.
To learn more:
- see the announcement
- read the aryoudense.org post