FDA Advisory Panel to review somo•v Automated Breast Ultrasound System

Women with dense breast tissue are a step closer to having access to an important new breast cancer screening tool.

On April 11, 2012, an FDA Advisory Panel is scheduled to decide whether to recommended approval of a new breast cancer screening indication for the somo•v® Automated Breast Ultrasound (ABUS) System. If approved by the FDA, the somo•v would be the only breast cancer screening tool approved for use as an adjunct to mammography for women with dense breasts.

STORY SUMMARY:

Most women who go for breast cancer screening expect mammography will provide them with accurate, early detection. According to the American Cancer Society, early detection can result in a survival rate of 96%.

However, while mammography is an effective tool at finding breast cancer, it doesn't work equally well in everyone. In women with dense breasts, more than a third of breast cancers are missed.

Dense breast tissue not only increases the risk of breast cancer up to 4-6 times but also makes cancer more difficult to detect via mammography according to multiple large studies. One study, published in the New England Journal of Medicine, showed 35 percent of breast cancer goes undetected by mammography in women with dense breasts, as density masks appearance of tumors.

Recently completed studies show the use of Automated Breast Ultrasound (ABUS) finds about 30 percent more cancers in women who have normal mammogram, normal physical examination and dense breasts. More than 40 percent of women in the United States have dense breasts.