Medical Device Daily National Editor

Computer-aided detection (CAD) has been shown to be an aid in detecting breast cancers using analog film technology.

Digital mammography has been shown to enable identification of breast cancers as readily as with analog systems, while also providing the added advantages of omitting film handling and film storage and offering seamless integration into a facility's other digital systems.

And CAD systems are now being used to enhance digital mammography as they have analog systems.

But let's not forget one problem related to all of the above: for many users, these new technologies, while not exactly new, aren't yet fully mature either.

And device developers well know what that means: evidence – enough to satisfy clinicians and, certainly just as important in today's evidence-based/cost-based healthcare environments, evidence to satisfy payers.

"There's a large body of data on how CAD works with analog," Jeff Hoffmeister, VP and medical director for iCAD (Nashua, New Hampshire), told Medical Device Daily, "but the body of evidence is not that large [for CAD] with digital mammography yet."

However, with a study in this month's issue of the American Journal of Roentgenology (Volume 192, Issue 2) – the journal of the American Roentgen Ray Society (Leesburg, Virginia) – the necessary evidence is growing, says Hoffmeister.

The study, titled "Detection of Breast Cancer with Full-Field Digital Mammography and Computer-Aided Detection," employs the company's SecondLook CAD system, and includes 123 cancers obtained with full-field mammography (FFDM).

The study finds:

that CAD with FFDM showed a high sensitivity in identifying cancers;

that SecondLook CAD correctly marked 94% of biopsy-proven cancers;

and that the sensitivity of iCAD's SecondLook system was not dependent on the size of the tumor; it was equally accurate with small and large lesions.

"This is just one more piece of evidence that supports CAD detection," says Hoffmeister.

And the company will use the new study to drive assurance among those looking to acquire digital systems, or have already done so, that CAD can be useful in making digital mammography more effective for clinicians wanting to provide the best service for their patients in a cost-sensitive environment.

"The impact [of the study] is a confirmation of that expectation," Hoffmeister says, adding that the acquisition of a digital mammography system ought to be linked to the combination with CAD as an obvious add-on value to the system.

An iCAD representative reported that of the 8,800 mammogram centers in the U.S., 47% have adopted digital technology and that more than 90% of these have also acquired a CAD system for the additional analysis that it provides.

SecondLook can be integrated into – or, to use iCAD's press statement term, "optimized for" – digital mammography systems from GE Healthcare (Waukesha, Wisconsin), Siemens Medical Systems (Malvern, Pennsylvania), Fujifilm Medical Systems (Stamford, Connecticut), IMS Giotto (Pontecchio Marconi, Italy), Agfa Healthcare (Mortsel, Belgium), and Sectra (Stockholm, Sweden).

Hoffmeister acknowledges that the new study also is good news for Hologic (Bedford; Massachusetts).

Hologic makes the Selenia digital mammography system with integrated CAD tools, called Citra on SecurViewDX. The two companies share the U.S. market about 50/50, according to iCAD.

Kathy Schilling, MD, a radiologist at the Center for Breast Care, Boca Raton Community Hospital and the Boca Radiology Group (Boca Raton, Florida) and one of researchers who developed the new study, told MDD that her facility has been using the SecondLook system in some of the earliest clinical trials of the technology.

And she says that with the system's FDA approval in 2002, the center switched from using two radiologists to read mammogram images to one reader, the SecondLook substituting computer eyes for the second reader, thus fulfilling the technology's brand name.

That move, combined with some minimal reimbursement from CMS, has made the system cost-effective, adding a dollar benefit to its strong ability to identify cancers.

She also notes that the new study supplies the clinical support to keep insurers from pulling back from reimbursement, which she suggests is something they occasionally attempt with newer technologies.

Radiologist Juliette The, MD, also at Boca Raton Community Hospital, cites SecondLook's ease of use "and ability to help radiologists find more cancers, at an earlier stage. Coupled with full-field digital mammography, which has been shown to be more accurate in certain populations of women, we feel that CAD is an important tool that highlights the areas of a mammogram warranting closer inspection."

Schilling notes that the Boca Raton facilities where they work are early adopters of CAD systems breast MRI, and Schilling says she sees potential for the use of CAD in a variety of imaging modalities. "It's absolutely going to become more important" with some of these.

The study does come with some qualifiers, which may or may not be of interest to potential buyers.

Schilling owns stock in iCAD, and two other researchers listed as involved in the study reported that they own stock in and are employees of iCAD.

Another qualifier is that the 123 patients in the study is not a number offering robust clinical power, and in the report the researchers acknowledge that larger numbers are needed in future studies, "including prospective studies ... to assess the potential for CAD to reduce radiologist false-negatives ...."

But the study clearly identifies a key benefit of CAD technology that iCAD and Hologic are likely to promote: the technology's sensitivity "in identifying cancers manifesting as calcifications and masses" and maintaining CAD sensitivity "in cancers with lower mammographic sensitivity, including invasive lobular carcinomas and small neoplasm."

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