Over the years ultrasound has evolved as an adjunct to mammography, becoming a valuable tool for use in the diagnosis of breast cancer. Historically, the gold standard for routine breast cancer screening involved radiographic mammography technology but imaging limitations for those patients with dense breast tissue was an issue; dense breast tissue makes mammography interpretation difficult as radiographic images of dense breast tissue appear similar to cancer.
This introduced ultrasound as a ‘second look’ option for patients, especially those with dense breast tissue. However, like mammography, ultrasound has its own set of limitations as the process is very user dependent and scanning the breast is difficult, inconsistent and time consuming. These issues led to the development of a new ultrasound technology that addressed some of the limitations, leading to the birth of automated breast ultrasound (ABUS). Advantages with the ABUS technology includes a reduction in the time of procedure and operator dependency as the equipment utilizes transducer technology that automatically scans the breast in several seconds, acquiring volumetric image data that can address the issue of dense breast tissue.
Over the past few years, some states have also begun to pass laws requiring sites that perform mammography to inform patients when they have dense breast tissue. These laws were created after an incident in 2009 when a Connecticut woman with dense breast tissue was diagnosed with advanced breast cancer that the mammogram had missed. She had not been informed by her doctor that she had dense breast tissue. She took her story to the state legislatures and soon after Connecticut became the first state requiring women be told if they have dense breast tissue and insurance companies to cover ultrasound scans for these women. Other states with such laws currently include Connecticut, Texas, Virginia, California and New York. Under the laws the patient is informed that dense breast tissue can hide tumors on a mammogram and it may increase the risk of breast cancer going undiagnosed. The patient is encouraged to ask the physician if they need additional screening tests such as ultrasound or MRI exams.
Ultrasound is expected to be effected greatly by these laws due to the relative lower cost of technology, widespread availability and technological advancements that have shown detection accuracy as a supplement to the mammogram. MD Buyline has seen several vendors market ABUS Systems, including Siemens with the S2000 ABUS, U-Systems with the somo-v ABUS and SonoCine. While this new technology initially created some interest, over the past several years interest and quote activity from MD Buyline members has declined in regards to ABUS. Questions potential customers face are related to the expense associated with having an ultrasound system dedicated solely to breast imaging and issues of reimbursement for this application.
Despite remaining relatively quiet, the market experienced a bump last December when at the time of the RSNA 2012 Meeting it was announced that the FDA had approved U-Systems’ somo-v Automated Breast Ultrasound system for breast cancer screenings as an adjunct to mammography for asymptomatic women with dense breast tissue. This resulted in the somo-v ABUS being the only approved ABUS for breast cancer screening and this remains the case as of now. Also at this time, GE announced the acquisition of U-Systems and reported that GE offers the most comprehensive portfolio of breast care innovations on the market.
Review of the MD Buyline Database for Quotation activity as of Q1 2013 shows minimal interest and activity for ABUS technology. In the past 12 months we have reviewed five quotations for the U-System somo-v ABUS and only two since the FDA approval for breast screening, six quotations for the SonoCine ABUS technology and no quotations for the Siemens product. Clearly, the healthcare community is taking a ‘wait and see’ approach to this technology. Follow-up with some facilities that are evaluating the equipment have indicated an interest due to residing in a state with a breast density law on the books. A director with a facility in the process of evaluating ABUS commented that the radiologists are skeptical of the procedure and the law creates challenges such as workflow adaptations and cash pay services for a non-FDA approved device for breast screening.
General ultrasound breast imaging has been very popular due to the advantages as an adjunct to mammography and the ability to identify lesions missed by X-Ray. MD Buyline is seeing increased growth of traditional ultrasound systems dedicated to Women’s Healthcare and for breast imaging applications. As procedure volumes grow and issues of reimbursement become clear, investment in ABUS technology will become more economically feasible. I expect over the next couple of years we will begin to see ABUS activity increase.
I would really like to know your thoughts and experience regarding ABUS and would love to hear from you.