Experts Say Lab Industry Needs to Prepare for Adoption of Do-It-Yourself, Smartphone- Based Diagnostics

Like all other industries, the laboratory industry will feel the effects of the digital revolution. In some cases, digital technology will make operations more efficient and cut human errors by eliminating the need for written requisitions, faxes, and manual entry of test results. However, laboratories will be affected in previously unimagined ways too. Futuristic fantasies are rapidly becoming realities and within a few years experts predict patients will be able to perform clinical-grade testing in their homes through their smartphones.

At-home, smartphone-based testing will hasten the co-occurring trends of moving testing towards the patient and the move to using only micro-samples of blood, urine, and saliva. Through wirelessly enabled, handheld devices and smartphones with cameras and/or small, plug-in accessories, patients will be able to perform diagnostic testing (is it a viral cause of cold-like symptoms?) and monitor an expanded array of chronic conditions, much as diabetics have monitored their own glucose.

“Unimpeded by geographical boundaries, smartphone-linked wearable sensors, pointof- need diagnostic devices, and medical-grade imaging, all built around real-time data streams and supported by automated clinical decision–support tools, will enable care and enhance our understanding of physiological variability,” predicts Eric Topol, M.D., from the Scripps Translational Science Institute, in a review published April 15 in Science Translational Medicine.

Defining the Trend
Despite all of the excitement and investment ($2 billion in venture capital in digital health in the first half of 2015, according to Mercom Capital Group), mobile health (mHealth) remains in its infancy and lacks a universal definition. mHealth is a subset of the broader term digital health that includes price-comparison platforms and even physician rating sites. Clinical laboratory-type smartphone testing represents an even smaller, more nascent subset of mHealth, which can include health and wellness smartphone applications too. (This article will focus on user-enabled clinical laboratory-type testing on smartphones.)

mHealth is feasible today because of the convergence of personal computing power with mobile connectivity.

“The first supercomputer, the Cray-1, cost $5 million, weighed 5 tons, and used as much electricity as twenty homes and it could not even play a song, a game, or make a phone call. iPhones are 100 times more powerful than the Cray-1 and we carry them in our pocket or purse,” says author John Patrick, D.H.A., formerly the vice president of Internet technology at IBM.

By all accounts smartphone-based testing is in the very early days, but enthusiasm for its potential is great. Consumer do-it-yourself testing, like all new things, experts say, will have nonuniform adoption initially. Some patients with chronic diseases, the “worried well,” and some clinicians will enthusiastically embrace the convenience and real-time benefits of the technology, while others will be distrusting of the quality and utility of patient-generated data. High-quality evidence to support adoption is still needed and regulatory issues and business models are still being framed. Yet, experts are convinced, this movement will be upon us rapidly.

What does this mean for laboratories?
“Too often, studies of mHealth technology have been designed to answer the question ‘How can ‘these technologies’ fit into existing systems of care?’” says Topol, who is the Gary and Mary West Endowed Chair of Innovative Medicine at Scripps. “The more appropriate question is ‘How can systems of care be altered to best take advantage of ‘these technologies?’” … The implementation of mHealth technologies only as adjuncts to existing systems of care likely will lead to results that fall well short of demonstrating their true impact.”

Now is the time for laboratories to develop a framework for ensuring these test results are used clinically and to define a role for themselves given the anticipated evolution of the industry. With high enough quality of data, payers’ interest in these smartphone-based tests will grow as testing moves to “least-cost” settings.

“New innovations in the diagnostic world have lived within the reference laboratories,” Chris Wasden, Ed.D., executive director of the Sorenson Center for Discovery & Innovation at University of Utah, tells DTET. “Diagnostics were performed in a clinical environment, processed by large organizations in batches, and results were sent to a clinician for interpretation. It hasn’t been very consumer-oriented, but now all pressures are driving towards a consumer-centered model.”

While the initial inclination is for laboratories to view do-it-yourself, smartphone-based testing as a competitive threat, experts say that laboratories really need to look for the opportunity.

“This is an unstoppable phenomenon,” Patrick predicts. “Is health care immune? No. If I was a lab director, I’d say, it has happened to all of the other industries. I probably shouldn’t ignore it. I can’t fight it, so how can I participate?”

Industry leaders are beginning to envision what participation might look like.

“We serve as expert advisors in diagnostic testing. As clinical laboratory medicine expands to the point-of-care in professional health care settings and into the medical home, we will continue to be consulted as domain experts in the field,” Sharon Geaghan, a professor of pathology at Stanford University, told the American Academy of Clinical Chemistry in an April 2014 interview on home-based specimen collection. “In addition to the analytic testing and interpretation of test results from home-based collection kits, there are new professional opportunities offered by an increase in home test collection.

Laboratorians are essential to successfully implementing self-collection programs and designing community-based or patient-centered recruitment efforts to increase participation in … screening programs.”

David Dean, associate director at Cambridge Consultants (developers of the home-testing Flow Health Hub), says that by pushing “smart point-of-care” tests to the patient, laboratories could free up capacity to do more innovative, high-value, complex testing that they may otherwise not have the capacity to perform. Other experts say that traditional laboratory and diagnostics companies’ experience with the regulatory environment makes them a valuable partner to technology companies from outside of health care.

Regulation
Back in February, the U.S. Food and Drug Administration (FDA) issued a guidance to clarify the subset of mobile apps it intends to regulate. Analysts say that the guidance offered the budding mHealth industry some needed clarity. It says approval will be needed for accessories to medical devices and accessories that transform mobile platforms into a regulated medical device.

“Regulation can be an obstacle, but it can save lives,” says Patrick. “Think about it. If there is the slightest hiccup or bug on an iPhone, it is a big deal online. Shouldn’t we expect the same high expectations for how a medical device should work?”

For smartphone-based laboratory tests, experts say there is now no question that FDA approval is needed. The only question is which pathway—reliance on a predicate device or filing a premarket submission for a novel device.

“The problem is that the FDA requires a predicate device to avoid a lengthier, costlier, approval process,” Wasden tells DTET. “But, predicate devices don’t exist. A few years ago we didn’t have mobile phones acting as super-computers. We didn’t have advanced microfluidics like we have today. We are doing things differently.”

Takeaway: Despite concerns over security and the quality of patient-generated mHealth data, experts expect the technology to become more widely commercially available in the next several, so laboratories must act to become valued partners in adoption of this industry-altering technology.