regulatory hurdles, including clinical trials, for eventual approval by the FDA.
Qin says the device can detect infectious diseases, such as cholera, following a natural disaster when power and sanitation systems are shut down or insulin levels for soldiers on the battlefield. It also could be used to do routine checks for important parameters like cholesterol levels in patients in villages without access to modern healthcare facilities.
The chip’s uses even extend beyond medical diagnosis. “This could be used for water purification, if you find an appropriate marker,” says Joanne Mitchell, director of Methodist’s tech transfer office. “This is a broad platform.”
Typically, such tests are done in a laboratory environment using large, complex equipment such as mass spectrometers. Or caregivers reach a diagnosis through fluoroscopy analysis, which must also be done in a lab.
The potential market is huge. Point-of-care diagnostics is expected to grow to $16.5 billion in 2016, according to BCC Research in Wellesley, MA. Such diagnostics can include glucose monitoring—the largest segment—blood chemistry analysis, and diagnosing infectious diseases or tumors. Eliminating even a few days of waiting for a laboratory—when one is available—to come back with results is significant, especially one when treating patients with fast-moving diseases like cholera.
The development of a diagnostic laboratory-on-a-chip has long been a goal of medical researchers. Because of the importance of rapid diagnoses for the military and in areas without lab facilities, for instance, the Defense Advanced Research Projects Agency, or DARPA, and the National Institutes of Health have been funding a number of research teams. For instance, grant funding has helped GE Global Research, the technology development arm of General Electric (NYSE: GE), and University of Washington scientists to develop a diagnostic device, the size of a pack of playing cards, to detect infectious disease with a nasal swab.
In a similar project, Singapore’s Agency for Science, Technology and Research (A*STAR) and Veredus Laboratories