While evidence shows that the use of CAD with screen-film mammography is equal to or better than single reading of the screen-film mammography (SFM) images, there is scant information on the performance of CAD with FFDM. Logically, it might seem that CAD should play the same role with FFDM as with SFM, but the differences between film and digital mammography - which show up in the greater accuracy of FFDM in certain populations - preclude extrapolating from the impact of CAD with SFM to CAD with FFDM. The large increase in the magnitude of the data collected by FFDM, the ability to fine-tune the digitally acquired images, and the elimination of the digitization step make FFDM sufficiently different from SFM that separate studies on the impact of CAD on FFDM are needed. Until results from better studies focusing on the use of CAD with FFDM become available, the benefits of CAD with FFDM cannot be determined.
Based on the available evidence, the Blue Cross and Blue Shield Association Medical Advisory Panel made the following judgments about whether the use of computer-aided detection (CAD) as an adjunct to single reading of full-field digital mammography meets the Blue Cross and Blue Shield Association's Technology Evaluation Center (TEC) criteria.
1. The technology must have final approval from the appropriate governmental regulatory bodies.
Two CAD systems have received premarket application (PMA) approval by the U.S. Food and Drug Administration (FDA) for use with FFDM.
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes.
While there is a growing literature on the use of CAD with screen film mammography, there are very few articles that look at CAD with FFDM. Because the FDA approved the CAD devices for use with FFDM as a modification of their original approval of the CAD systems for use with SFM, whatever data were used to support the request for pre-market approval of these CAD systems with FFDM are not readily available. The articles on the use of CAD with FFDM are inadequate to determine the incremental impact on sensitivity, specificity, and biopsy rates.
In summary, the available evidence is considered insufficient to permit conclusions on the effect on relevant outcomes of using CAD after initial radiographic interpretation as a quality adjunct to single-reader mammography in patients having full-field digital mammography for screening or diagnostic purposes.
3. The technology must improve the net health outcome; and 4. The technology must be as beneficial as any established alternatives.
The available data from well-conducted studies are insufficient to make a determination of whether adding CAD to FFDM leads to diagnoses that are as or more accurate than reading the FFDM images alone. Given the lack of data on these intermediate outcomes, it also is not possible to determine the impact of CAD on health outcomes such as treatment success, recurrence rates, and survival. As a result, it is unclear whether health outcomes are the same or better with the use of CAD with FFDM compared to single reading of FFDM alone.
5. The improvement must be attainable outside the investigational settings.
Given the inability to determine whether the use of CAD improves health outcomes, considering the generalizability of the impact of CAD is premature.
For the above reasons, the use of CAD systems as an adjunct to single reading of full-field digital mammography images does not meet the TEC criteria.