By Heather Mayer and Brendon Nafziger, DOTmed News reporters

A new modality that captures 3-D images of the breast and which is touted to improve cancer detection faces scrutiny this week, as a U.S. Food and Drug Administration panel is set to decide whether to recommend that the agency let the device hit American markets.

On Friday, the FDA's Radiological Devices Advisory Panel will review Hologic, Inc.'s 3-D digital mammography unit, for which the company has been trying to get approval since 2008.
Friday's meeting will look at the company's data regarding the Selenia Digital Breast Tomosynthesis System to determine its safety and effectiveness in screening or diagnosing breast cancer.

Bedford, Mass.-based Hologic, which focuses on products for women, said the new system produces clearer images that can help detect cancer that otherwise could be hidden behind breast tissue.

The FDA has said it's concerned about issues over reader training in analyzing the scan, and possible study bias. Friday's meeting will also look at whether the benefit of detecting cancer outweighs the risks of patients being exposed to extra radiation through this exam. The panel's recommendations are not binding for the agency.

The company originally filed for approval in 2008, but since then has been required to obtain additional data. The technology is already available for use in some 40 countries, including those in the Middle East, South America, Asia and Australia. It is also commercially available in Canada and Mexico.

Rival device makers, including Siemens, Fujifilm Medical Systems and GE Healthcare, also have tomosynthesis devices in the works.

The Hologic device captures 3-D images of the breast by swiveling the X-ray tube head in a 15 degree arc over the breast, taking between 11 and 21 X-ray snapshots. The pictures are then reconstructed to make cross-sectional slices of the breast.

"This panel review of our Selenia Dimensions breast tomosynthesis system is part of the FDA process of assessing this remarkable new technology," said Rob Cascella, Hologic's president and CEO, in remarks this past July. "We believe tomosynthesis represents the next phase in breast cancer detection - fast, high-quality 3-D imaging of the breast. We are thrilled to have a panel date set ... as an important step in the review of our next-generation technology."

FDA concerns

The FDA's concerns focus on a pair of studies submitted to the agency as part of the device's application. While both studies showed a drop in the recall rate of non-cancer patients, only one did so without missing cancer patients.

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