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Breast-care advice tests firms

New guidelines could hurt mammography equipment makers

By Robert Weisman
Globe Staff / November 18, 2009

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The region’s makers of mammography systems, digital detectors, and medical imaging software are bracing for the fallout from guidelines released Monday that suggest women start regular breast cancer screenings at age 50, rather than 40, and get mammograms every two years instead of annually up to age 74.

While companies say the recommendations from the US Preventive Services Task Force won’t have an immediate impact on their business, they worry the guidelines could lead to fewer screenings - especially for women in their 40s - and to longer intervals between hospital orders to replace mammography equipment.

“This is another blow to the equipment industry,’’ said Maria Shepherd, founder of Data Decision Group, a Belmont research firm specializing in medical devices. “This could take away a big portion of the population that gets screened. Anybody who sells equipment is already having a hard time, because hospitals are having to make really tough choices’’ about how to spend money in a slow economy, she said.

Mammography systems can cost hundreds of thousands of dollars, making them big-ticket purchases for health care providers, especially smaller community hospitals.

Shares of Hologic Inc., based in Bedford and the world’s largest maker of digital mammography systems, retreated 3.5 percent, or 55 cents, to $15.12 on the Nasdaq exchange yesterday.

The company, along with others, was quick to point out that the new recommendations differ from those of other organizations, such as the American Cancer Society and the American College of Radiology, which continue to recommend that women over 40 get annual mammograms.

“We have expected this [task force] announcement for some time, and have been analyzing the effect it might have on our business,’’ said Hologic spokesman James Culley. “We do not feel there is sound medical evidence supporting changes to the screening age or interval.’’

Other companies that could be affected by a decline in breast screening include Aurora Imaging Technology Inc., a North Andover developer of breast magnetic imaging resonance systems; Analogic Corp., a Peabody maker of diagnostic imaging equipment; and Advanced Image Enhancement Inc., a medical imaging software start-up in Providence that uses technology developed by the Naval Undersea Warfare Center in Newport, R.I., to detect mines.

Michael Duarte, cofounder of Advanced Image Enhancement, said the company’s image-processing applications have been included in the latest software suite assembled by Hologic, which will be embedded in its new mammogram machines and marketed as a software upgrade to health care providers with older equipment.

The software improves the clarity of tumor detection in dense breast tissue. Difficulty in identifying tumors in denser breast tissue, which is common in women under age 50, was one of the factors cited in the guidelines proposed by the preventive services task force.

“If it does turn out that age segment is closed out, it would be a somewhat smaller market,’’ Duarte said. “It may drive some of the smaller hospitals and clinics out of mammography. I don’t think this will have an immediate impact. We’re going to have to wait and see how it’s adopted, or if it’s adopted, by women and the medical community.’’

One key issue, said Shepherd at Data Decision Group, will be whether Medicare and private insurance payers embrace the recommendations and stop covering mammograms for women in their 40s.

“Once insurance companies no longer pay for it, that would begin to have a big effect,’’ she said.

“They’ll all be watching to see who will be the first to stop covering it, and what kind of impact that would have in terms of negative publicity or loss of customers and clients.’’

Aurora Imaging, whose magnetic resonance imaging systems for breast screening use a different kind of technology than that cited in the new guidelines, nonetheless is concerned a shift in thinking about the effectiveness of screening could erode its market niche - especially because radiologists often order breast MRI screens as a complement to mammograms.

“We’ve grown very rapidly with the technology for breast MRIs,’’ said Debbie Thomas, Aurora’s vice president of marketing. “But it wouldn’t be hard to imagine these guidelines could lead to a decrease in the frequency of all imaging [methods], including MRIs.’’

Companies working on the digital end of mammography say their advanced technology increasingly will help to eliminate false positives in screenings - negating another factor behind the revised guidelines.

“In the past 24 hours, we’ve done some thinking about this,’’ said Mark Namaroff, director of strategic marketing at Analogic, which supplies digital detector plants to mammography equipment makers like Siemens Healthcare, Philips Medical Imaging, and Toshiba Medical Systems.

“At the end of the day, doctors and women are going to make the decision whether to get screened. And we don’t think they’ll stop.’’

Robert Weisman can be reached at weisman@globe.com.