A new screening process for breast cancer approved by the FDA on Sept. 18 will afford greater protection to women who have dense breast tissue.
The new system is called the somo-v Automated Breast Ultrasound System, or ABUS, and will allow doctors to differentiate between dense breast tissue and the smaller tumors that can be missed in regular mammograms.
“A physician may recommend additional screening using ultrasound, for women with dense breast tissue and a negative mammogram,” Dr. Alberto Gutierrez, director for the Office of In Vitro Diagnostic Device Evaluation and Safety, said in a statement. The department is part of the FDA’s Center for Devices and Radiological Health.
Gutierrez said the somo-v ABUS is “a safe and effective breast ultrasound tool when such screening is recommended.”
According to the FDA, somo-v ABUS sends high-frequency sound waves through the selected part of the body. The entire process takes one minute and when completed, doctors can analyze images of the entire breast that are created by the sound waves bouncing off of the tissue.
The visuals given to the physician allows them to see any abnormalities in the tissue that might normally be missed because dense, fatty fibroglandular breast tissue and tumors both look like opaque white areas under current screening methods.
This causes women with dense breast tissues to often be diagnosed only in the later stages of the disease.
According to the National Cancer Institute 40 percent of the mammograms performed are done on women with dense breasts.
Somo-v ABUS is only approved for women who have not had surgery, a biopsy, or any other type of “clinical breast intervention,” as this could possibly distort the results of the ultrasound.
According to the Centers for Disease Control, breast cancer is the leading type of cancer among women after non-melanoma skin cancer. African Americans have the second highest rate of developing the disease, but rank first for the number of women dying from the condition each year.