Barco is stepping up efforts to make soft-copy solutions a vital tool in gastrointestinal exams. U.S. regulatory authorities this month cleared the company’s colonography software application for distribution to the potentially sizable screening market.
Barco is stepping up efforts to make soft-copy solutions a vital tool in gastrointestinal exams. U.S. regulatory authorities this month cleared the company's colonography software application for distribution to the potentially sizable screening market.
The company, headquartered in Kortrijk, Belgium, developed an active interest in soft-copy tools last fall, following its acquisition of 3D medical imaging software specialists Voxar (DI SCAN 09/29/04). At the time, Voxar's Colonscreen software had 510(k) clearance from the FDA to aid visualization of colonic tumors, polyps, and other lesions in symptomatic patients. The software had also received a CE mark, sanctioning its sale throughout European Union countries.
This latest application permits Voxar Colonscreen to be marketed in the U.S., not only for visualization but also for the detection of pathologies in the colon, clearing the way for its use in screening. Its uptake, however, could hinge on the wider acceptance of CT colonography itself.
"It is a very large potential market," said Carter Yates, senior director of strategic marketing with Barco. "The next hurdle to get across in the U.S. will be for the major healthcare payers, particularly Medicare, to reimburse for screening using virtual colonography."
Voxar Colonscreen is not the first software tool to be cleared for CT colonography screening. Viatronix of Stonybrook, NY, got FDA approval to market its V3D-Colon virtual colonoscopy system as method of detecting colon pathologies last April. This followed a paper in the December 2003 New England Journal of Medicine on the software's performance as a diagnostic tool compared with conventional colonoscopy.
The main advantage of Voxar Colonscreen over its rivals is its ability to boost radiologists' productivity, Yates said. He ascribes this to key workflow features. Preprocessing of CT data is unnecessary. Fly-through views show tissue surrounding the lumen, as well as the colonic surface itself, promoting detection of possibly relevant extracolonic findings. Radiologists can scan simultaneously through reconstructions derived from patients lying in two different positions, which may aid differentiation of polyps from residual fecal matter. Points of interest can then be marked up, and relevant 2D and 3D views integrated into a structured report.
"With this, you can do your exams more quickly than with other products out there," Yates said. "From beginning to end, it's just faster and more efficient."
But no matter how smart the visualization aids, the success of such software packages rests on growth in CT colonography. That essentially comes down to colon cancer screening. Patients presenting with signs of colon cancer will be referred for CT only if they cannot tolerate a conventional exam, Yates said.
"That's a fixed percentage of patients that hasn't really changed over time," he said. "It's a steady business that is important, but the real majority of use for such a product would be in screening the at-risk population."
Interest in colon cancer screening has grown on political agendas over the past few years, fueling considerable discussion of the clinical value and cost-effectiveness of competing techniques. CT colonography is currently not included among tests recommended by the American Cancer Society for early detection of colorectal cancer, nor is it used widely in Europe. Barco plans to continue its support for peer-reviewed studies into CT colonography on both sides of the Atlantic, in the hope that clinical results will prove persuasive.
"In encouraging the studies to be done, or supporting the studies, I think we are helping get to the point where payers get more comfortable with this approach," Yates said.