Hologic Inc. is trying to give breast cancer detection an upgrade.
The Bedford medical-equipment maker, which dominates the market for mammography machines, is planning to launch its next generation of the X-ray machines within the next year - a so-called 3-D version.
Using a process called digital tomosynthesis, the new machines take pictures of the breast from a series of slightly different angles, which doctors can then scour for signs of tumors. Hologic says the new machines will give doctors about 100 images of each breast, compared to just two with the current technology.
"This is as big a change for mammography as CT scans were to body imaging," said Hologic's cofounder and chief technical officer Jay Stein.
Radiologists say tomosynthesis promises several key advantages over the current two-dimensional digital and film snapshots.
First, it gives a more comprehensive view of the breast, so radiologists may be able to spot cancerous tissue hidden behind other tissue. Now, doctors miss 20 to 30 percent of breast cancer in regular mammography exams, industry executives say.
Physicians may also be able to more quickly resolve concerns about possible signs of cancer. Currently, about 10 percent of women are called back for a second exam, even though doctors eventually find nothing wrong in the vast majority of those cases. Hologic says three-dimensional systems cut the recall rate by nearly half.
In addition, Hologic also faces competition from other companies, such as General Electric Co. and Siemens, which are working on their own versions of tomosynthesis. GE says it expects to launch its 3-D systems in two to three years, though Hologic believes GE is likely just a year behind. Siemens is also a few years away from marketing a 3-D system.
"The basic technology is the same" for all three companies, said Joseph Lo, assistant professor of radiology and biomedical engineering at Duke University Medical Center, who is leading a clinical study of the Siemens system. "There are some fine differences, but I believe the results [in detecting cancer] will be very similar."
Indeed, Massachusetts General Hospital is testing both GE and Hologic machines, and so far has not found that one is significantly better than the other in detecting cancer, despite GE's claim that its system offers higher resolution, officials say.
"There probably won't be a lot of qualitative differences," said Dr. Elizabeth Rafferty, director of breast imaging at the hospital, who is heading clinical studies of Hologic's system. "They're both on the right track."
Modern mammography - using X-ray machines to spot breast cancer - traces its roots to the 1950s and 1960s. But mammography didn't become common until the 1980s, after the technology became more sophisticated and studies showed the value of mammograms in helping to spot cancer.
In most machines today, a women's breast is positioned on a flat panel, then pressed down with a paddle to help spread out the tissue and hold the breast in place. A large X-ray machine then beams radiation through the tissue, hitting a screen that converts the radiation to visible light and exposing a slide of film.
GE introduced the first machines to replace film with digital images in 2000. But even though GE launched the digital machines first, Hologic eventually caught up and now sells more than anyone else. Hologic claimed 55 percent of US mammography revenue in 2006, compared to 34 percent for GE, according to Life Science Intelligence Inc., a market researcher in Huntington Beach, Calif. Siemens and Fuji are a distant third and fourth. Hologic said breast health products, like mammography, account for 45 percent of its $1.7 billion in annual revenue.
Hologic is widely expected to become the first to launch 3-D mammography later this year, but it is already at least two years behind schedule. In November 2005, Jack Cumming, the company's chief executive, said it expected Food and Drug Administration approval by the end of 2006. Now the company says it hopes for FDA approval by the end of 2008, with its US launch coming in early 2009. The company is already taking orders in Europe and expects to start shipping systems there later this year.
"There's definitely some uncertainty," said Leerink Swann & Co. analyst Isaac Ro, adding that he still thinks Hologic is a year ahead of GE and even farther ahead than Siemens and other competitors. Leerink helped Hologic with a recent stock offering. "It's been a moving target for two years," Ro said.
GE marketing executives said they expect further delays with Hologic's machines, arguing Hologic does not yet have enough data to convince the FDA that its system is effective in patients. But Rafferty said she wasn't aware of any FDA qualms with the data. Ro also said he thought Hologic was on track for approval later this year. Hologic says its new machines will still let doctors view the conventional 2-D images, so it calls its new machines a combination 2-D/3-D system.
Of course, even after the FDA approves the first 3-D systems, it could take hospitals time to make the switch. Cumming guessed it would take a couple years for major insurers to start reimbursing hospitals for the cost of the new mammography machines and for doctors to become comfortable with the new technology. At that point, Cumming and Ro believe, the new technology will skyrocket.
"It should be 2010 - that's when you'll see the real acceleration," Ro said.
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