Wednesday, September 28, 2011

Help for Women with Dense Breasts: U-Systems' somo-v Automated Breast Ultrasound (ABUS)

The movement toward enhanced breast screening for women with dense breast tissue is gaining momentum. Today's blog is meant to help these women advocate for a specific supplemental screening option: automated breast ultrasound. We'll focus on the somo-v ABUS system from U-Systems. I'll use a Q&A format.

First, how does Automated Breast Ultrasound (ABUS) differ from regular ultrasound?
Both use sound waves to detect abnormal structures in the breast that could be tumors. With plain vanilla ultrasound (hand-held ultrasound, or HHUS) either a radiologist or a highly-trained technician called a sonographer moves a kind of wand ("transducer") over the surface of the breast. Think of the wand like a flashlight. As the she moves the wand, she looks at the image on a monitor in real-time, trying to see possible tumors. Images can also be captured for later viewing.  With ABUS are that a much larger transducer is configured over the breast (it isn't manually moved over the breast), automatically taking different ultrasound images from different angles. These are then processed by a computer to construct a 3-D image.

What are the main advantages of ABUS?
First, the 3-D image gives a more complete picture of the entire breast than HHUS. Second, the images can be compared from year to year, or between visits, so any changes in the breast are easier to detect. Finally, the method doesn't require a diagnostic medical sonographer to perform. The imaging is automated, similar to mammography. So you don;t have to worry about whether or not the technician might be less experienced. Most ultrasound sonographers are trained and accredited. But their level of experience can also matter with HHUS.   

What systems are out there?
The main system on the market is called (and this is a mouthful...) the somo-v INSIGHT Automated Breast Ultrasound (ABUS) system.  It was developed by U-Systems, a Silicon Valley company that pioneered the field. A similar competing system called the ACUSON S2000 Automated Breast Volume Scanner (ABVS) is marketed by the large German company Seimens AG.

Can Automated Breast Ultrasound be used for screening?
The simple answer is "Yes, and it increasingly is." But realize that breast ultrasound, automated or not, is usually performed as a diagnostic procedure to further characterize a suspicious mammogram or MRI result. It's also commonly used to help surgeons guide needles when they perform biopsies.  Ultrasound is not traditionally used for screening to assess women with no suspicion of disease. However, given the growing concerns about mammography and women with dense breast tissue, ultrasound is increasingly used as a second, supplemental screening method for that subgroup of women. Generally, screening methods need to be more automated and require less technical skill than diagnostic methods, simply because more tests have to be performed more rapidly.  This is part of the appeal of the ABUS system.  But read on...

Is ABUS approved as a screening method in the US?
No. It's approved for diagnosis, but not for screening. That doesn't keep physicians from using it as a screening method. It does keep U-Systems from marketing it for screening. U-systems is conducting a very large study (20,000 women with dense breasts) in the United States to gain approval for screening. The study is looking at whether screening with mammography plus ABUS outperforms mammography alone.  Here we're talking about traditional 2-D mammography and not 3-D mammography (tomosynthesis). Enrollment continues, but the company already feels the data are strong and so they submitted an application to the FDA in April 2011. They added to the data a few weeks ago. The FDA could decide any day now.

Is ABUS approved as a screening method outside the US?
Yes, in Canada and in Europe. It was approved as a screening method by the Canadian regulatory agency Health Canada just last month (Aug 2011). Here's the announcement. It was granted European Union marketing approval a year ago (Sept 2010). Here's some info on that.

Is there a way I can see how it works?
The somo-v system was recently featured on Dr. Oz. Their site has three videos of that episode, which is all about supplemental breast screening. Watch all three if you have time.  If you just want to see the somo-v system, just watch part 2. Once you get there, you'll see the links to parts 1 and 3. Sorry but they're going to subject you to some commercials...

How much does it cost? 
That depends on the facility providing the service, but typically about $250-300.

Will it be covered by insurance?
That also depends on the judgment and policy of the facility you use, but often it's reimbursed.

How can I find a doctor that performs ABUS in my area?
First, you might check to see if you can get access through U-Systems' clinical study. Data from the trial have already been submitted, but they might still be recruiting. Outside of the clinical trial, it might take you a lot of time to call breast centers on your own. I'd probably just call the company (1-866-364-6777). Legally, remember, they can't talk about the system for screening. So just ask where there's a system installed in your area and hold the screening questions for the facility. Let's just call it "don't ask, don't tell!"

Where can I find more information?
Go to the somo-v Automated Breast Ultrasound page on the website. There we list web links to high-quality news articles and medical journal abstracts about every new medical option.

No comments:

Post a Comment