3-D mammogram study questioned

Bloomberg News / September 23, 2010

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WASHINGTON — Hologic Inc.’s re-use of cancer cases in a study of its three-dimensional breast-cancer detector raises concerns the trial’s results may be biased, according to US regulators weighing whether to approve the device.

Training provided to radiologists in the study also may have skewed the results, Food and Drug Administration staff reviewers said in a report issued yesterday.

The device, known as Selenia Dimensions, is designed to identify tumors that could otherwise be masked by overlapping tissues, according to the Bedford, Mass.-based company. The product already is sold in Europe, Asia, South America, and Australia. There aren’t any major safety or effectiveness obstacles to US approval of the device, which was submitted to the FDA in 2008, said Ira Loss, an analyst at Washington Analysis.

“The bigger issue is whether hospitals will buy it,’’ Loss said. “There’s a lot of concern about reimbursement. It may be difficult to sell into this particular market.’’

An FDA advisory panel is scheduled to meet tomorrow to review the findings and vote on whether the device’s benefits outweigh potential risks.

“We’re still positive on the potential of a positive panel meeting supporting the safety and efficacy’’ of the device, Joshua Jennings, an analyst at Jefferies & Co., said.

The 3-D device may render 2-D mammography obsolete in three to five years, Hologic chief executive Robert Cascella said Sept. 14 at a conference.

Hologic already sells a 2-D version of the machine in the United States.