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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. 

"The decrease in cancer recall rate in Reader Study 1 raises concerns, but the results for Reader Study 2 suggest that with better training the recall rate could decrease without the loss of cancers," the agency said. 

Also among the agency's worries is the level of radiation per scan. The FDA's Mammography Quality Standards Act requires the radiation dose to the breast not to exceed, for a typical breast, around 3 mGy for a single craniocaudal view. In phantom studies submitted to the FDA for the Hologic device, the agency said total dose for 2-D plus 3-D, totaling four views, is 5 mGy, and for three views, 3.5 mGy. 

However, the FDA said the "glandular dose to a phantom simulating a standard breast for 2D plus 3D would be less than twice the MQSA limit for single CC view." 

A spokesman from Hologic told DOTmed News that dose for 2-D and 3-D combined falls below the FDA regulatory limit for a single 2-D exposure, and that the additional effective dose from the 3-D scan is about the same as two months of annual natural background radiation. 

The response from the market has been mixed. Hologic's stock fell 3.9 percent to close at $15.42 on Nasdaq. But some analysts are upbeat about the device's prospects. 

"[We] believe that risk/reward heading into the [Center for Devices and Radiological Health] panel meeting is favorable," Jefferies, an investment bank, said according to Benzinga.