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May 14, 2019 | The Philadelphia Citizen
When computer engineer Mihir Shah was about to get married in 2007, the joyful occasion was overshadowed by a shock: His mother-in-law was diagnosed with breast cancer, had to undergo chemotherapy, and attended the wedding covering her head with a wig.
The experience motivated 41-year-old Shah to research breast cancer treatments, and he was surprised to realize that the survival rates of women with breast cancer largely depend on one factor: where they live.
Shah hails from Mumbai, India, but has lived in Chester Springs near Philadelphia since 1997, so he is familiar with the health care in both countries. While his mother-in-law received state-of-the-art treatment and is now cancer free, this is not the reality for most. “The survival rates are incredibly different,” Shah says. “In the US, 90 percent of women with breast cancer live for at least five years; in India it’s somewhere between 50 to 66 percent; in Uganda 46 percent.”
One crucial difference, Shah found, was early detection. In developing countries, most women don’t have access to mammograms. In India, for example, Shah says there is one radiologist for every 100,000 people; in the United States, it’s 12.
Shah, who was an Entrepreneur in Residence at Drexel for three years, set out to look for a solution. He came upon a ceramic sensor developed at the university by Drs. Wan and Wei-Heng Shih, and licensed the technology in 2010. Over the course of three years, Shah’s colleague, Matthew Campisi, worked with a team of about 20 researchers, engineers and clinicians to design iBreastExam, and then worked with local maker space NextFab to make a prototype. Along the way, they secured funding from Drexel ($200k), University City Science Center ($100k), and the Pennsylvania Department of Health ($900k), as well as private investors and social-impact fund Unitus Venture, based in Seattle.
The small, battery-powered, handheld machine resembles an oversized pink and white whistle and gently vibrates when you run it over a woman’s chest. Without causing any pain or radiation, it detects abnormal breast tissue as small as 3 millimeters within a few minutes. “The basic principle is the fact that abnormal breast tissue, including breast cancer, is stiffer and harder than normal tissue,” explains Shah. “In simple words, when a clinician does a breast exam, this is what they are looking for with their hands, trying to feel areas that do not move as easily.”
The machine emulates that process. When the iBreastExam discovers abnormal tissue, the machine highlights it in its corresponding mobile app. “With the machine, you can put that capability in the hands of anyone, even a social worker with little training,” Shah says.
The device has been approved in 12 countries, and currently about 250 devices are out in the field. According to Shah, the technology has been used to screen more than 250,000 women and led to the detection of more than 120 breast cancer cases that would otherwise not have been diagnosed. Several studies, including at the University of Pennsylvania, have shown that the machine detects breast cancer with an accuracy of about 87 percent.
The machine itself currently costs around $10,000, and each scan comes to around $1 to $3;Shah believes he could reduce costs once more machines are produced. That cost is a fraction of that of a mammogram.
UE LifeSciences now has about 70 employees spread across seven offices in the U.S., India and Malaysia, as well as distribution partners in 10 countries. Shah says the company multiplied revenue five times between 2016 and 2018, and will break even for the first time this year. Meanwhile, foundations such as the Pfizer Foundation and the Bayer Cares Foundations, are currently sponsoring screening programs in Burma and Brazil.
Shah emphasizes that the machine is not meant to replace mammograms, but to help early detection, “to identify the small group that needs to go forward for further screening.” The next step after the iBreastExam identifies suspicious tissue is usually an ultrasound, which is available and affordable in many rural areas, then potentially a biopsy.
UE LifeSciences works primarily in developing countries—India, Mexico, Indonesia, Thailand, Myanmar, Nepal, and Oman—where, according to Shah, 90 percent of women don’t have access to mammograms. “We know the person at the front line is a woman health worker, she is not a doctor, so we tried to build a device that can withstand these limitations and yet provide quality early detection,” he says. The training of the health workers to use the machine takes between four to eight hours.
Brian Englander, associate professor of clinical radiology at the University of Pennsylvania was initially skeptical of iBreastExam, and expected the machine to fail when Shah asked him to evaluate it. “Mammography is the standard of care,” he told the New York Times. But the sensitivity of the device convinced him. “I hope something like the iBreastExam would be accepted in the United States because there’s places and groups that don’t have access” to breast cancer screening.
The technology could help women in Philadelphia and other parts of the U.S., particularly those in underserved populations. More than two-thirds of uninsured women don’t get routine mammograms. And black women have a 40 percent higher risk of dying from breast cancer than white women, mostly due to lack of access to health care. The same holds true for other minorities in the U.S. who might not have access to affordable preventive health care, might be afraid of radiation or have other concerns.
The iBreastExam is radiation free. General practitioners could use it as part of routine checkups to flag early warning signs. Shah does not advertise the iBreastExam as a replacement for mammograms, but he believes it can fill a glaring gap in early detection. “Women below 45 years of age who are not eligible for mammograms have a lower risk, but they are another vulnerable population,” he notes. “Mammograms are also not as effective in women with dense breasts. The advantage is that there is no bias in terms of breast density.”
The FDA has already cleared iBreastExam in the U.S. as a “breast lesion documentation system.” Technically, Shah says, he could sell it here, but he believes that “for a much wider adoption, we need to lay the ground first. There is no dearth of gadgets, but we want to do justice to its potential, not just have it be another piece of electronics.”
At least in the U.S., he wouldn’t encounter the same suspicions as in his birthland. Once he walked in on Indian villagers who ran the handheld device over the belly of a pregnant woman to see if it could detect the sex of the fetus. Due to the high risk of aborting unwanted female babies, determining the sex before birth is illegal in India. Shah smiles. He believes his invention could accomplish a number of feats, including help reduce breast cancer risks. But no, it can’t tell if someone is expecting a girl.