New 3-D Mammography Test Approved by the FDA

Posted on Mar 14, 2011

The first-ever three-dimensional diagnostic test for breast cancer was approved by the United States Food and Drug Administration (FDA) in February 2011. In the wake of this breakthrough, breast cancers are expected to be easier to detect, and the 3-D tests also may eliminate many unnecessary tissue biopsies.

Until now, the 3-D screening method has only been tested in the U.S., even though it has already been approved in Europe. Because extensive training is needed before radiologists can properly interpret the results of a 3-D mammogram test, the FDA approved the system as a supplement to the traditional 2-D test.

The difference between the two mammograms is that with the 2-D technology, only two images are taken and abnormalities can be easily missed or obscured by surrounding tissue. With 3-D technology, a multitude of images are taken and can create a much clearer depiction of the internal structure of the breast.

Created by Hologic Inc. of Bedford, Massachusetts, the new 3-D technology can be installed by medical centers that already have the company's 2-D technology in place. Though the software upgrade would cost around $150,000, initial studies have shown that 3-D and 2-D technology utilized in conjunction with one another significantly reduces the number of times women are called back for additional testing due to inconclusive test results with the 2-D method alone.

Potential downsides of the testing method are increased radiation exposure for women using 3-D over 2-D, as the amount of exposure may actually be doubled. Though higher than with 2-D mammography, this level of radiation exposure is still within the limits established by the FDA.

Currently, the Mayo Clinic recommends that regular mammograms begin for women at age 40.

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