From the July 2017 issue of HealthCare Business News magazine
The Invenia ABUS
GE Healthcare acquired U-Systems in November 2012 and developed its Invenia ABUS, which got the FDA nod in June 2014. It’s currently the only ABUS system that can be used as a screening adjunct to mammography.
The European Asymptomatic Screening Study, which was published in the European Journal of Radiology in October 2016, found that the Invenia ABUS increases breast cancer detection by 57 percent. The analysis involved 1,668 women between the ages of 40 and 74 who underwent 15-minute ABUS exams after digital mammography screening.
The findings were equivalent to 6.6 cancers detected per 1,000 women compared with the 4.2 cancers detected using mammography alone. In addition, 23 women who underwent mammography alone were recalled for further testing, but only 15 women who received the supplemental ABUS exam were recalled.
Dr. Jason Davis, radiologist and director of imaging at OSF Medical Group in Illinois, has been using the Invenia ABUS as a supplemental screening tool for women with dense breasts since February 2016. He prefers it over conventional handheld ultrasound.
“Handheld ultrasound used for screening was shown to be good, but the problem is that it consumes a lot of time and resources, and screening exams are not supposed to be that way,” he says.
He believes ABUS gives the patient and reading radiologist another level of confidence. He explains that mammography detects only 50 percent of breast cancer in women with dense breasts, but adding ultrasound can bring that rate up to 90 percent.
“When [dense breast] cancers are finally detected, they tend to be larger cancers at a higher stage,” he says. “We would like to catch those at the size they are when cancers are found with mammography.”
There isn’t a dedicated screening reimbursement code for ABUS like there is for mammography, but facilities can use the code for bilateral breast ultrasound to receive reimbursement
More than 200 facilities worldwide have purchased the Invenia ABUS and over 120 are in use in the U.S.
The state of the market
iVu Imaging Corporation, a small start-up company based in Texas, developed an ABUS system called SOFIA that’s different from other systems in that the patient is placed in the prone position. The company designed it that way in order to capture the entire breast at one time, instead of acquiring multiple views of the breast from different angles.
During the exam, the patient’s breast is coated with a warm acoustic lotion and placed into a funnel with a built-in transducer. SOFIA then takes 52 seconds to scan the entire breast and the entire exam, including acquisition and interpretation, takes about 10 minutes.
In December 2014, iVu announced that Hitachi Aloka Medical America, Inc. (HAMA) would be the exclusive distributor of SOFIA in North America. As part of the agreement, iVu used HAMA’s wide market reach to launch SOFIA to the masses.
Philips Healthcare also became involved in the ABUS market after signing an agreement with SonoCiné in February 2014 to incorporate the company’s AWBUS technology into its EPIQ and iU22 ultrasound systems.
The global ABUS market is flourishing. A Global Market Insights report from January estimated that the market will exceed $2 billion by 2024. Factors driving the market include the rising prevalence of breast cancer and programs and government initiatives that are creating greater awareness of breast density.
Certain segments of the market are expected to witness substantial growth through 2024. China’s market share made up over 60 percent of regional revenue in 2015 and is anticipated to reach approximately $1 billion by 2024.
Brazil is expected to grow at an annualized rate of 20 percent during the forecast period and surpass $60 million by 2024.
“The space is very attractive now for adjunct breast screening and we are seeing a lot of new entrance in this space,” says GE’s Suryanarayanan. “GE still continues to be the largest player, but we have seen a lot of smaller players coming in with their own versions of ABUS.”
Mammography remains the gold standard for breast cancer screening, but Suryanarayanan says researchers and many of GE’s customers are investigating whether ABUS could be a primary screening tool for women with dense breasts.
However, a large-scale clinical trial that demonstrates the performance of each modality on a population level will be required for guidelines to change.
“From what we can see, it seems to make sense because where mammography is weak, ABUS is strong,” says Suryanarayanan. “This whole notion of personalized breast care is the path in which the industry is moving.”
Back to HCB News
