Your phone is more than just a communication device. It is your alarm clock, your calendar, your bus schedule, and your record collection. It is personalized; a digitalization of day-to-day comings and goings tucked away comfortably in your pocket. This digitalization of you is exactly where hand-held technology is taking the future of health care. Electronic medical records will soon be made accessible to mobile devices, and new “lab-on-chip” technology is being developed to turn smartphones into mobile diagnostic labs. Soon, patients will have direct and immediate access to their medical and biological information anytime and anywhere they please.
“Smartphone labs” are an emerging area of development in clinical diagnostics. These devices, which many of us rarely part with, are the perfect platforms for portable biosensors. Achieving this requires an “add-apter,” which is an accessory to the smartphone managed by a downloadable app. The add-apter is a high-end component, such as an opto-electronic image sensor, embedded in mobile phones that can read raw images taken from a patient sample. The results are then processed by a downloadable app and delivered within minutes to the user. These rapid test devices thus allow for quick diagnosis and early detection of disease at a low cost, and can be performed just about anywhere without having to wait for results to be returned from the lab. Just last year (Dec 2014), a team from UCLA’s California NanoSystems Institute developed a 3D-printed optical device that uses the phone’s existing camera to image and determine the length of individual DNA molecules. This additional unit effectively turns the mobile phone into an advanced microscope with a laser diode that excites fluorescently labelled DNA. The raw image readout is transmitted to a UCLA server that will read the length of the single-stranded DNA molecule to an accuracy within 1 kilobase-pair (kbp) of a 10 or more kbp long DNA sample over a 2mm2 field of view, thus showing potential in the rapid visualization of chromosomal abnormalities in disease detection and prognostics. Earlier last year, a group led by Brian T. Cunningham from the University of Illinois received a grant from the National Science Foundation to start work on a next generation device based on a prototype that turned a typical smartphone into a high resolution spectrophotometer. This device would be able to read colorimetric tests, such as the enzyme-linked immunosorbent assays (ELISA) commonly used in the clinic, not only for diagnostics in the biomedical field but also in quality control of food and environmental safety industries.
The development of mobile and wearable “smartphone labs” will amplify the impact of individuals in driving health care. The conduit of information will flow directly into the hands of patients, which in itself opens up several conundrums. Is allowing direct patient access to this information a good thing? What procedural safeguards need to be in place in order to deal with false positive or false negative results? Furthermore, as is the case with all digital devices, security is paramount when private medical information is in play. These concerns, among others, are why the Food and Drug Administration (FDA) has not yet approved any smartphone-based rapid test devices. However, the last few years have seen several other forms of biomedical smartphone technology receive FDA clearance. Examples include physiometric monitoring systems like AliveCor®’s Heart Monitor and AliveECG app, which is an iPhone-enabled heart monitor; Vital Art and Science Inc. (VAS)’s myVisionTrack™, which enables patients of retinal diseases to monitor their vision function; and the iBGStar™ Blood Glucose Monitoring System, which allows in vitro blood glucose monitoring at home for diabetic patients. In addition, the software ResolutionMD®, which enables physicians to view patient reports and test images through a mobile device, also received clearance. More devices are in the pre-submission stage of their FDA submissions, and may eventually see daylight in the marketplace within the decade.
Dr. Eric Topol recently wrote in his 2014 Cell paper that the increasing accessibility of biological and medical data to individuals will be a, if not the principal, driver of medicine in the future. The emergence of smartphone-based biomedical technology can change how we diagnose and monitor disease. It remains to be seen whether smartphone-based add-apter screening devices will be the best way of establishing reliable portable biosensors, but its relative low-cost and immediate response may make it an appealing product to a highly health-conscious and increasingly mobile society.
This article was written with assistance from Sharon Cunningham, the President of ThyroMetrix Inc. ThyroMetrix is currently developing a smartphone add-apter that will perform quantitative tests for thyroid disease. Look for part 2 of this series in the next issue, which will feature an interview with Sharon about her company and her career path.
- Ozcan, A. 2014. Mobile phones democratize and cultivate next-generation imaging, diagnostics, and measurement tools. Lab Chip. 14(17):3187-94.
- Topol, EJ. 2014. Individualized medicine from prewomb to tomb. Cell. 157(1):241-53.
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