The Food and Drug Administration approved a powerful ultrasound Friday to help doctors determine when lumps in women’s breasts are non-cancerous - so those women can avoid a common surgical cancer test.
Advanced Technology Laboratories predicts its High-Definition Imaging, or HDI, ultrasound eventually will cut by 40 percent the 700,000 breast biopsies performed annually in the United States.
Out of those biopsies, 180,000 women are diagnosed with breast cancer every year. The rest have benign lumps.
Women must undergo a regular mammogram to detect any suspicious cells in their breasts. The ultrasound is intended to help doctors then decide which of those women need a biopsy to tell if the lesion is cancerous or benign and which can safely skip that outpatient surgery.
A biopsy costs about $2,500, while the 15-minute, painless ultrasound will cost $75 to $300, Bothell, Wash.based ATL said.
“No test is 100 percent, although this is very close,” said Dr. Brian Garra, a breast cancer specialist at Georgetown University Medical Center, who advised the FDA on the machine’s effectiveness.
But “it doesn’t mean a clean bill of health,” he warned, noting that women who likely have benign lumps still must be watched to ensure the mass doesn’t change, which can signal cancer.
A mammogram displays suspicious masses in breasts as blurry white spots against normal tissue.
Doctors can sometimes tell from a clear mammogram that the lesion is merely a cyst and may tell the woman just to get rechecked in a few months.
However, to be safe, many doctors order a biopsy, cutting out a tiny portion of breast tissue to check for cancerous cells. But doctors want to reduce the number of unnecessary biopsies performed each year to spare women anxiety, pain and expense.
Ultrasound sends high frequency sound waves into the body, which reflect back to create images. While weaker ultrasound is used in numerous medical procedures, ATL’s is the first strong enough to show a clear picture of breast lumps. If they have, for example, smooth edges and no irregular colors or dark shadows, they probably are benign, ATL says.
ATL said that when it tested the ultrasound on 1,021 breast lumps, it was 99 percent accurate in diagnosing lumps as benign. It missed one cancer - hidden in the shadow of a large cyst.
However, the ultrasound did have a high false positive rate: 41 percent of the lumps HDI indicated were cancerous turned out to be benign. But those are women who would have had biopsies anyway.
The ultrasound cannot picture the very smallest breast lesions, so FDA scientists recommended it be used on those at least 0.4 inches large.
Nine hospitals in eight states - in California, Texas, Pennsylvania, Alabama, Illinois, Ohio, Louisiana and Connecticut - already have trained doctors to use the ultrasound and can offer it immediately.
ATL is performing FDA-required ultrasound training for other doctors, and expect the machine to be in use nationwide by the end of the year.