Can Early Breast Cancer-Detection Be Painless, Low-Cost, and Radiation-Free?
Miles away from the nearest imaging center and wearing a kimono instead of a medical gown, I am sitting at the kitchen table in my Brooklyn apartment with Matthew Campisi, a professor of electrical and computer engineering at NYU. Goateed and genial, Campisi has stopped by to give me a demo of iBreastExam, a handheld breast-cancer-scanning device that he and fellow med-tech entrepreneur Mihir Shah began developing in 2009 as part of their UE LifeSciences health care start-up. “This is it,” he announces, removing the innocuous-looking pink-and-white appliance from a brown leather box.
Resembling a travel-size clothing steamer, the device uses an electronic sensor similar to a smartphone’s touchscreen to detect abnormal breast lumps as small as five millimeters. Cloud-connected and radiation-free, it allows health care workers to perform breast exams anywhere, in minutes, and without a degree in radiology. Over the past three years, iBreastExam—which has a distribution partnership with GE and has attracted research grants as well as venture capital funding—has been deployed in parts of the developing world where mammograms are scarce due to their high cost, a lack of electricity, or a dearth of radiologists (India has just one for every 100,000 people). Its usage has proliferated across Asia, Mexico, and Africa, where it has already screened a quarter-million women—and as of this month, the rollout is under way with gynecologists and primary-care physicians in select U.S. cities. It is poised to be the biggest innovation in early breast-cancer detection since the mammogram was widely introduced in 1963—and the average American doctor has never heard of it.
Part of that is by design, explains Campisi, who has close relatives who have survived breast cancer. “Our original plan was to fill a huge need specifically in the developing world, as most diagnoses were coming in at a very late stage,” he says. “And then a light bulb went off.” Why, he and Shah—an adjunct faculty member at Drexel University’s School of Biomedical Engineering, Science and Health Systems—wondered, shouldn’t they try to get the device approved for use in the United States?
“A quarter of patients in this country should be getting mammograms and just don’t,” says Brian Englander, M.D., chairman of radiology at Pennsylvania Hospital and an associate professor of clinical radiology at Penn’s Perelman School of Medicine, who has been conducting clinical trials on iBreastExam for more than a year. Fear of radiation and a mistrust of the health care system are often factors. But so-called health care deserts—underserved parts of the country where the closest radiologist might be miles away and insurance coverage may be at an even higher premium—have much to do with it as well.
“There is a developing-world demographic in many urban areas of the U.S.,” confirms Campisi. But he also sees enticing promise in serving the demographic that does have access to mammography. He’s promoting the apparatus as a way to document a clinical breast exam—“which, if you ask any O.B., is a missing link.” (I ask my own ob-gyn, who agrees—and is eager to hear more about the device.) “It gives you absolute, retrievable, reproducible data you can compare year to year,” Englander reiterates. “And the sooner breast cancer is diagnosed, the better the chances of successful treatment.”
Campisi logs my personal information into an Android phone (the most common platform worldwide), I slip off my kimono, and we get started. On a gray screen, each breast is divided into 16 quadrants; typically, only the middle four need to be measured, but this varies with breast size. He gently presses the padded sensor onto an upper quadrant of my left breast. Capturing data, a screen says. Green indicates no lumps; red means something has been detected. He measures four areas on both breasts. Each, thankfully, glows green. Data recorded. “Looks good,” he says as my husband, unperturbed, wanders into the kitchen for a sandwich. The whole process has taken five minutes.
While several studies have found iBreastExam’s sensitivity to be on par with a mammogram’s—including a 2016 article published in the World Journal of Surgical Oncology, in which iBreastExam demonstrated a sensitivity rate of 85.7 percent compared with a mammogram’s sensitivity rate of 85–88 percent—Campisi is the first to admit that the tool has limitations, one being that unlike mammograms, it can’t pick up microcalcifications: small deposits of calcium that can be an early sign of precancerous cells. “There is also a concern that people will say, ‘Well, I got an iBreastExam; I don’t need a mammogram,’ ” Englander points out. “But mammography is proven. So my hope is that if someone does get an iBreastExam, we can say, ‘Now that you’ve done it and it’s not that bad, let’s have you go for further evaluation.’ ” The technology’s potential to determine which women should go on to further testing is promising, agrees Victoria Mango, M.D., an eminent breast radiologist at Memorial Sloan Kettering Cancer Center in New York, which is conducting additional clinical trials on the device. For those in the trenches, it cannot be overstated how exciting that development is for fighting this disease. Adds Campisi, “We need all the tools in our arsenal to beat this thing.”
Originally Appeared on Vogue
