FDA OKs New Breast Cancer Test

A new device approved by the Food and Drug Administration may help reduce the number of women who get unnecessary biopsies because their mammograms are unclear.

TransScan Medical Inc.'s T-Scan 2000 uses electricity to map possible breast lumps. The FDA approved the device as an extra tool for radiologists to use in determining whether women with ambiguous mammogram results need an immediate biopsy to check for cancer.

"The device has the potential to reduce the number of negative biopsies, thus saving women worry about breast lesions that turn out to be non-cancerous," the agency said in a statement.

Doctors perform about 1.1 million biopsies a year, but only about 200,000 of them test positive for cancer, Carl Alfarano, chief financial officer of privately-held TransCan, said in an interview with Reuters. The rest are benign lumps. So scientists have hunted ways to reduce unnecessary biopsies without missing women who have cancer.

"There's a very high degree of false positives in the current practice, which generates anxiety, cost, scarring and other problems," Alfarano said. "This device can provide additional information."

American women undergo 30 million mammograms a year. The breast X-ray is the gold standard in detecting breast cancer, particularly early tumors.

Some doctors use ultrasound machines that use sound waves to picture lumps as an addition to the mammogram's X-rays.

Mammograms often clearly show which breast lesions should be biopsied immediately. But they also can be ambiguous, leaving a doctor in doubt as to whether to do a biopsy immediately, or to wait six months and X-ray again.

The T-Scan 2000 is another alternative. It uses electricity to create a map of the breast.

A one-volt shot of electricity is sent into the hand, where it travels through the body into the breast. A handheld probe is moved over the breast, where it measures the electrical conductivity of breast cells. Cancer cells conduct much less electricity than healthy cells -- so when the probe flashes its findings onto a computer screen, possible tumors show up as bright white spots.

TransScan's studies suggest that adding the electricity test for women with ambiguous mammograms can improve diagnostic accuracy and lower unnecessary biopsies by about 20 percent, said company president George Solomon.

The T-Scan should be used only in women whose doctors cannot decide about ordering a biopsy based on other standard procedures, said Dr. Dan Schultz, FDA's chief of radiological devices.

The new scan should add less than $100 to a woman's exam, Solomon said.

U.S. radiologists could begin using the T-Scan 2000 in about 60 to 90 days, Alfarano said.

The FDA said three studies involving nearly 1,200 patients showed that using the T-Scan improved radiologists' accuracy in diagnosing cancer.

"When used along with mammography, T-Scan gives doctors a useful tool to enhance care of women whose mammogram rsults are ambiguous," the FDA said.