orr.jpg (8823 bytes)After 15-plus years of promoting early detection via mammography, specialists in breast cancer are being pursued by a host of new technologies and diagnostic opportunities. Target markets for these devices include luminaries, researchers, clinicians and patients. Manufacturers are actively positioning their products as both cost-effective and patient-effective tools. The market is certainly listening, as healthy attendance at the Society of Breast Imaging’s 5th Postgraduate Conference meeting in San Diego recently demonstrated high levels of both scientific and market interest.

The primary driver behind this interest is the continuing opportunity for improved early detection and diagnosis of breast cancer. Mammography alone provides a good screening and diagnostic service, widely used and extensively tested. The limitations of mammography in dense breasts, lesions and masses are now routinely discussed at the scientific level, and computer-assisted-detection (CAD) and digital mammography are new additions to the X-ray modality of testing. CAD is clearly targeted at improving the radiologist’s ability to identify important information contained in the mammogram. Digital mammography, on the other hand, is intended to deliver new information via an image, adding more contrast for evaluating soft-tissue features by way of a wider dynamic range. While both CAD and digital mammo each have only one FDA approved manufacturer (R2 Technology and GE Medical Systems, respectively), many more FDA submissions are in the pipeline.

The second key modality for breast cancer diagnosis is ultrasound, which initially entered the field by evaluating lesions or masses for distinguishing their cystic or solid properties. The development of higher performance ultrasound transducers and systems has now positioned ultrasound as a controversial tool for “screening” applications as well. Luminaries recommend ultrasound for a series of specific diagnostic and screening indications (patient management applications), but are carefully guarding their words regarding broad-based screening (not yet ready for this step).

Other tests discussed in some detail at the meeting include MRI and nuclear medicine or functional testing. MRI is in a stage of extensive research as a tool for high-risk breast cancer screening, i.e., women who have a family history or clinical indications that place them at high risk for this disease. This approach matches well with the extensive time and cost associated with MRI, but offset by the clinical value that the procedure delivers. The patient demand for breast MRI is presently running ahead of the science, as there is no data demonstrating the efficacy of breast MRI (just early clinical trials), and no standardized method for performing the study or interpreting the images. A high false-positive rate currently accompanies breast MRI, as many benign lesions and normal breast tissue demonstrate contrast enhancement, and require biopsy testing to distinguish them from cancer. Researchers are unified in recommending that breast MRI only be performed in conjunction with clinical trials, not as a normal screening or diagnostic test. Nuclear imaging also is garnering attention in clinical trials, albeit more limited than MRI tests, and is less in demand by patients although it provides some unique metabolic information, especially in high-risk patient groups.

Other breast cancer tests include electrical conductivity of breast tissue cells (TransScan Medical), thermal mapping of breast tissue (CTI) and optical imaging of breast tissue (DOBI and CT Laser Mammography). Most of these procedures are seeking applications to differentiate malignant from benign tissue, in order to reduce the number of biopsies performed, largely as a result of the limited specificity of mammography and ultrasound tests.

The performance of breast biopsy tests was substantially altered by the introduction of X-ray equipped prone-breast biopsy tables in 1992 (by Fischer Imaging and Lorad). Biopsy attachments to free-standing mammography systems also are now widely used, and biopsy systems using ultrasound guidance are used in abundance. The reason for the biopsy is to make a definite diagnosis, indirectly pointing out the limitations of imaging, especially the high false-positive rate that drives many negative biopsy results.

So, what are patients to make of all this effort and investment in the field of breast cancer imaging today? In the U.S., we have a growing population that obtains screening services using imperfect technology for definitive detection and diagnosis of the disease. We have improving, new and developing technologies to deploy, and hospitals and imaging centers, largely focused on women’s health, that are interested in maintaining their clinical positions by buying and testing these new methods. Funding for breast cancer research is still widely supported in the U.S. High growth areas in clinical breast cancer management are presently limited to CAD and digital X-ray, with CAD presently favored to outperform all industry growth projections.

From the radiologists’ perspective, confusion and uncertainty are notable, as these specialists assess the practical implications — financial, staffing, patient management — of investing in expanded capacity and new capabilities. With the coming shortage of radiologists, productivity tools and improved performance of main-stream diagnostic devices such as X-ray and ultrasound look to be sure-fire winners. Predictably, augmented analysis devices must follow the paths of clinical trials as their road to the future.

Doug Orr, president of J&M Group (Ridgefield, Conn.), consults with medical device companies in strategy and business development for emerging growth markets, notably radiology and cardiology. Comments and suggestions can be sent to [email protected].