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48 Draper Laboratories developing hand-held, point-of-care TB test By LYNN YOFFEE Medical Device Daily Staff Writer Tuberculosis (TB) is still a killer in developing countries with one of the primary hurdles to controlling disease spread being a fast, cost-effective diagnostic tool. Draper Laboratories (Cambridge, Massachusetts) is about to start a human trial to test a hand-held, point-of-care TB testing device that has already been used for several years by the military in biodefense applications. “We see that in the future Differential Mobility Spectrometry (DMS) will eventually be able to determine if someone is infected with TB just by exhaled breath, but that’s in the experimental stage. What we’re working on now is to identify TB from sputum,” Jose Trevejo, MD, senior biomedical scientist, Bioengineering Division at Draper, told Medical Device Daily. “A lot of infections are detected using ELISA. But there’s something about TB’s biology that the standard approach of using antibody detection doesn’t work well. We’ve come up with a new approach to detect the biomarkers.” The Centers for Disease Control and Prevention (CDC; Atlanta) reports that more than nine million people get sick each year with the TB bacteria that usually attacks the lungs and almost two million die. The tests currently available to diagnose TB are a sputum culture, a skin test and a blood test, all of which require trained healthcare workers, special lab equipment and the need for patients to return for a follow-up. “I think the DMS would have a huge impact on the global TB situation,” Trevejo said. “There’s a huge need. I went to an international meeting last year and physicians there told me they have a lot of problems diagnosing TB. The gold standard that’s more sensitive, a culture, takes one to three weeks, is expensive and requires an advanced facility. Most of the time it’s not feasible, testing takes too long and they lose the patient in follow-up. They need something rapid. This could be a paradigm-shifting technology.” The DMS technology is currently used by the military and through a license to Sionex (Bedford, Massachusetts). “It’s a MEMS [microelectromechanical systems] chip that’s the size of a dime. It has a small sensor,” he said. “When you introduce volatiles, it detects ions. Fully assembled prototypes are as small as a deck of cards.” He explained that the DMS technology is different from electronic noses, which work by pattern recognition. “This is more like mass spectrometry, the gold standard, and has similar sensitivities,” he said. It rapidly analyzes volatile organic compounds (VOC) in the sputum or breath. “To date we have identified over 16 VOCs associated with TB,” he said. “For the initial development we focused MEDICAL DEVICE INNOVATION 2010 on three compounds which were expressed in the highest amount.” Trevejo said Draper is collaborating with the University of Texas (Brownsville) to initiate a 25-patient study in Mexico within the next six months. If all goes well, a larger trial will be initiated. Upon clinical validation, his team will start the regulatory review process. He speculated that the device, with an approximate one-year lifetime, would cost $1,000 to $2,000 and individual tests would cost as little as $1. Trevejo said other teams around the world are working on point-of-care TB diagnostics, but, “We think our instrumentation is much more advanced. We have a good lead on the biomarkers and it will enable us to identify the bacteria with more sensitivity too. Our main advantage is that our devices are already portable, already sensitive and potentially point-of-care.” (This story originally appeared in the Aug. 30, 2009, edition of Medical Device Daily) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
MEDICAL DEVICE INNOVATION 2010 Drexel makes portable, radiationfree breast cancer detector By OMAR FORD Medical Device Daily Staff Writer The only approved FDA breast cancer screening system in the U.S. is mammography beginning at age 40 for women. The main issue is the effectiveness of the screening device is often substantially lessened in women with dense breast tissue. The mammogram also provides little to no information on the stiffness or mobility of a tumor and has a sensitivity level of 85% but in dense tissue breasts that decreases to 65%. Researchers at Drexel University (Philadelphia) are vying to bring their developed breast cancer detector to market, a device which could overcome the limitations of a mammogram and provide a portable and radiation free alternative to the clunky devices. The detector is based on piezoelectric fingers, an elastic and shear modulus sensor developed at the university. The proposed screening tool will be positioned as an early breast cancer test to be used by physicians and gynecologists in the clinical setting in conjunction with the physical examination. It supplements mammography to screen early for breast cancer in women with dense-tissue breasts. “We have been working of this for quite a long time,” Wan Shih PhD, a breast cancer survivor and an associate professor in Drexel’s School of Biomedical Engineering, Science and Health Systems told Medical Device Daily. “I envisioned this device in the early 2000’s. The device was not originally intended to detect breast cancer. I was envisioning a device that could measure the elasticity of tissue.” But five years into the program Shih changed the focus of the device and geared it more toward detecting breast cancer, a disease which she survived. Shih said that the PEF device is comprised of a handheld probe with small electrical measurement units that can be operated by a laptop computer. Here are some highlights of the device: • Palpation-like tissue stiffness imaging both under shear and under compression with less than one-millimeter spatial resolution up to a depth of several centimeters. • Use of the shear modulus/elastic modulus ratio to measure tumor mobility to screen for malignancy. • It has demonstrated more than 90% correlation between the shear/elastic modulus ratio and tumor malignancy – a capability all existing technologies lack. • With a single or double 1.5 cm wide PEF of depth sensitivity of 3 or 6 cm, it can probe for breast cancer for almost all body types. • Patients are in a supine position which poses no discomfort. • The PEF is gentle. It only works with less than 1% strain, which would cause minimal discomfort to the patient. Researchers are also saying that there are cost benefits for using the device as a pre-screening system. The portable system much would be much cheaper and require fewer operators than ultrasound, MRI and nuclear medicine tests. Plans call for Shih to make bid for the device to be commercialized and seek FDA clearance. “There are several entrepreneurs talking with us about licensing the technology,” she said. “As for FDA approval right now we’re planning on having clinical trials in India and China. And the reason we want to go in to those places is because there are a higher percentage of women with dense breast tissue in China than in the U.S.” Ultimately the goal is to have a calculator-size electrical measuring unit and a less than a less than 5” x 5” x 5” 3-D automation unit to operate the PEF. This imaging tool will help the physician locate smaller breast tumors than the current technologies and screen for tumor malignancy at the same time to save lives. As to when the device would actually hit the market, Shih said it would be realistic to think that we could see it in clinics in about five years. Shih added, “It’s really not complicated. It’s not radioactive and it’s very friendly to the human body.” (This story originally appeared in the Sept. 28, 2009 edition of Medical Device Daily.) 49 To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
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