You may remember our post in October about the recently FDA-cleared SenoBright Contrast Enhanced Spectral Mammography system developed by GE Healthcare. We wanted to provide you with more information about SenoBright and GE’s plans, so we took advantage of the opportunity to interview Anne LeGrand, GE Healthcare’s Vice President and General Manager of its global X-Ray & Mammography business:
Shiv Gaglani, Medgadget: Ms. LeGrand, I know you’re currently en route from Paris to the US so thank you for taking the time to speak with us.
Anne LeGrand: It’s my pleasure, Shiv. The audience that Medgadget reaches is an interesting mix of healthcare professionals, engineers, and tech enthusiasts so I’m happy to do this.
Medgadget: Excellent – we’ll begin at the beginning. SenoBright was announced by GE in June 2010 and received FDA 510(k) clearance in October 2011. What’s been happening in the meantime?
LeGrand: We introduced SenoBright to the European market at the end of 2010. At the same time we were working on our 510(k) clearance, which we were excited to receive last month. SenoBright is technology offered as an upgrade to our existing Senographe platforms, which makes it easier for an existing clinical site doing diagnostic mammography to adopt since the system and workflow of each system are similar. I like to think of SenoBright as an incredibly sophisticated “app” that augments the original platform.
Medgadget: Interesting, so how does SenoBright actually work?
LeGrand: The technology behind SenoBright is also known as contrast enhanced spectral mammography (CESM). Procedurally, it’s very similar to traditional mammography. For example, it still takes only a few minutes to perform the procedure, an iodine contrast agent is used to visualize diffusion within the breast tissue, and a low-energy X-ray is used to generate the primary image. With SenoBright we added one more higher-energy X-ray so that we could perform something called “a dual-energy aquisition,” meaning we could compare the images produced by the two different X-rays and remove a lot of the confusing noise [conceptually similar to reducing the appearance of red eye in photos by adding additional light flashes]. This allows SenoBright to highlight areas of interest and has proven incredibly helpful for dense breast tissue.
Medgadget: I’ve seen the example images produced by SenoBright and they look fantastic. Has GE performed or sponsored any studies that assess whether CESM actually improves diagnostic capabilities and/or patient care?
LeGrand: Absolutely, there have been a number of studies coming out of teams in Europe [including this one from France]. The findings validate that SenoBright is useful in helping to localize a known or suspected lesion. A perpetual challenge facing diagnostic technologies is false positives that result in additional costs, waiting times, and unnecessary anxiety for the patient. With SenoBright’s technology, both specificity and sensitivity may be improved when used as an adjunct to digital mammography and ultrasound. To name a few statistics from early research, compared to conventional mammography alone, SenoBright can spot 13 percent more cancers, correctly classify 6 percent more benign lesions, and send home 19 percent more patients who do not have cancer.
Medgadget: You mentioned that SenoBright uses X-rays of two different energy levels. As we reported last year, this includes the conventional energy of 26-32 kilovolt peak to discern morphology as well as the higher 45-49 kVp to capture diffusion of the contrast agent. Given this new energy peak, are there concerns for over-exposure to radiation?
LeGrand: It’s a good question, and we found that the SenoBright dosage is average about 20 percent higher. Remember though that this is a diagnostic exam. Some of our partners have described this as being equivalent to performing an additional view, which is standard diagnostic procedure when in the situation where a physician is trying to confirm or rule out a suspicion.
Medgadget: That’s good to hear. In addition to SenoBright, and while we have you on the phone, we’d like to know more about your global X-ray division’s recent move to China – a first for GE – which was announced this past July. In an interview with the Wall Street Journal, you said that you expect 20 to 25 percent of GE Healthcare’s X-ray products to be developed in China during the next three to five years. Can you please comment on the move and your division’s plans?
LeGrand: You’ve done your research! I moved to China earlier in the year and what it means is that the division that I manage has become much more global. Four of my senior executives are in China and we spend a lot of time between our sites in Beijing, Paris, and Wisconsin, among other places.
GE has invested $500 million to build customer innovation centers in China. In Beijing I have a very strong R&D team focused on traditional digital & analog radiography. We are also just starting up a center in the western city of Chengdu that will focus on value products for radiology specifically meant to address the needs of rural areas. The Chinese government is making a significant investment through its Western Zone economic expansion to develop stronger medical offerings in this area. The goal is to develop products in China for China, in China for other developing markets, and eventually in China for other global markets. GE has a strong history of global innovation and collaboration; for example, our Bangalore R&D center develops all of the software for our radiology solutions.
Medgadget: Fascinating, we’ll definitely be looking out for news about products developed to address the needs in China. As the 2011 Breast Cancer Awareness Month comes to a close, it’s interesting to consider how global the disease actually is. Has GE been doing anything special for Breast Cancer Awareness Month?
LeGrand: More than 1.2 million people around the world are diagnosed with breast cancer. Many more are not diagnosed because they are not aware or do not have access. This year during Breast Cancer Awareness Month, GE promoted both awareness and access by making more than 25 human pink ribbons in global communities. For example, I was in Paris recently where 350 of us made a human pink ribbon right near the Eiffel tower. We also had a mobile mammography machine on site to raise awareness of mammography screening. We consider it our responsibility as a healthcare company to raise awareness. I’m very passionate about this, having been in healthcare for many years. Anything we can do to improve awareness and access to diagnostic tools is both an opportunity and responsibility of GE.
Medgadget: Great to hear. We appreciate your time and insights, Ms. LeGrand, and look forward to keeping up-to-date on emerging medical technologies coming out of GE.
LeGrand: You are welcome. It was my pleasure.