As Medical Testing Goes Mobile, Risk and Opportunity Rise

There’s a neat trick that Sharon Weiss, Ph.D., likes to do when she’s participating in STEM outreach events for schoolchildren. She takes porous silicon films, similar to soap bubbles, and drops certain liquids onto the surface of the film. The result is a vibrant color change in the film, the consequence of how light interacts with the nanostructure of the material.

Weiss, an engineering professor at Vanderbilt University, specializes in light-matter interactions and nanotechnology, work that also takes her into the sphere of biomedical imaging.

Perhaps it was inevitable that she would make a connection that could dramatically change how we perform a whole range of medical tests. Weiss realized that a smartphone has all the components necessary to detect even subtle color changes in nanoscale porous silicon. That meant, in theory, that a smartphone could serve as a sensor to interpret results when a bodily fluid such as urine or blood landed on a silicon chip that had been pre-treated with a special coating.

It was a challenge Weiss couldn’t resist.

“The opportunity to show that the more complicated sensing experiments we previously carried out in our laboratory with benchtop instrumentation could be carried out with a phone in your pocket was an intriguing research challenge that we wanted to pursue,” she told Inside Digital Health™.

Last month, the results of her work were published in the journal Analyst. And while a number of engineering challenges remain before the device can be commercialized, her results point to a dramatic change in the way patients could soon undergo an expansive range of medical tests: The medical labs of the future aren’t just mobile, they’re in your pocket.

Increasing Prevalence of At-Home Testing

The advent of at-home testing isn’t news to Mindy S. Christianson, M.D., an assistant professor of obstetrics and gynecology at Johns Hopkins Medicine.

“As a fertility specialist, I would estimate that at least half of my patients are already performing some type of home testing prior to their initial visit,” she said. “The most common that I see is home ovulation predictor kits for those attempting pregnancy.”

But Christianson told Inside Digital Health™ that several patients have come to her after doing a new type of test: at-home sperm counts or semen analyses.

Still, while Christianson said assessments such as home pregnancy tests are highly accurate, they’re not as specific as the tests she does in the clinic. At her lab, she can order other tests, like serum HCG quantitative levels, that give her more granular and informative results.

Michael S. Blum, M.D., a cardiologist who leads the University of California, San Francisco’s Center for Digital Health Innovation, also sees more patients leveraging the power of their smartphones.

Patients with chronic diseases increasingly use such tools to track blood pressure, heart rhythms and diabetes.

Sometimes, with established patients, Blum said at-home measurements are sufficient bases upon which clinicians can make certain treatment decisions, such as medication adjustments, without the need to replicate the results in the clinic.

“For the near future, I would expect that an initial in-person visit will be required to validate the results of in-home testing and do a relevant examination,” he told Inside Digital Health™. “However, I can foresee a time in the not-too-distant future when we have more experience with the devices, where low-risk management could occur initially via virtual visits.”

Artificial intelligence is likely to have a significant impact on this space in the coming years, offering the ability to collect data and also provide patients with guidance for minor flare-ups or other issues.

Another advancement rapidly changing the landscape is direct-to-consumer genetic testing. However, Blum said, such data are complex and require careful interpretation before medical decisions can be made based on these tests.

Ethical Concerns for At-Home Medical Tests

Genetic testing offers an important case in point. With genetic testing, a patient can theoretically learn that they have, or are likely to have, a devastating disease. Historically, only a trained medical professional would deliver such news. Today, however, such results could come directly to the patient.

That idea is worrisome to Christianson, who said providers play a vital role in delivering life-changing test results to patients.

“I think it’s important, in the event of a devastating diagnosis such as cancer, that a patient have a medical resource person immediately available,” she said. “It’s better to share that news with a patient, either face to face or on the phone.”

At UCSF, researchers have been working to balance the need to meet patients’ increasing expectations of quick results with the need to ensure that results are delivered in an appropriate manner by a medical professional.

“While it may seem paternalistic, the unnecessary stress, anxiety and damage that can be done to a patient who receives bad news without context or support is real and needs to be minimized,” he said.

Even Weiss, who is working to make it easier to perform a wide range of tests at home, agrees that at-home results aren’t always optimal.

“These are important questions to address,” she said. “It is hard to imagine a future where you do not have traditional doctors in the healthcare loop.”

Medical Test Error Warning

Even for relatively simple, low-stakes testing, another issue arises. What if the test is inaccurate? At-home testing not only introduces the possibility of human error but also the possibility that the test or app itself is flawed. After all, despite pushing providers to adopt new technology, regulators have yet to catch up with the emerging healthcare app industry. As a result, many apps and other devices that offer what appear to be medical services are not regulated like medical devices.

“The risk of incorrect data or interpretations is real and significant,” Blum said. “I think that both providers and regulators are currently grappling with this new world of at-home healthcare technology.”

Christianson agrees, saying there’s a significant risk that patients might make healthcare decisions based on invalid data.

Still, she said, that risk shouldn’t mean a retreat from at-home testing. In addition to making it easier and quicker to get medical test results, these new technologies can also make such testing cheaper.

“For instance, if a male partner didn’t have insurance coverage for a semen analysis, then a home test that detected sperm and provided a rudimentary sperm count could be helpful in at least confirming there are sperm,” she said.

However, if the infertility problems persisted, Christianson would want to perform a comprehensive semen analysis in her clinic’s andrology lab.

In short, while at-home testing raises significant regulatory and ethical issues, Christianson, Blum and Weiss all agree that at-home testing will play an important role in the future of healthcare, even if it doesn’t replace professional laboratory testing.

“At least in the near term, I would expect that smartphone-based systems would be used to complement existing testing technology,” Weiss said. “In cases where resources are limited and extreme detection sensitivities are not necessary, the smartphone could offer an excellent solution.”

The day when all medical testing is done on a mobile device is still in the realm of fiction. At least for now.

“One day we may finally have a tricorder, as envisioned many years ago in Star Trek,” Christianson said.

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