In the original 1960s Star Trek television series, the Dr. McCoy character had a diagnostic device called a Medical Tricorder, a computer with a deployable hand-held scanner that he used to measure crew members’ vital signs and symptoms. That fictional medical marvel has now become a reality. Contestants in the $10 million Qualcomm Tricorder XPrize competition—announced in 2012 and concluded in April—designed devices capable of diagnosing at least 13 health conditions and continuously monitoring five vital signs, all with a consumer-friendly interface and weighing no more than 5 pounds. Qualcomm announced the winning team, Final Frontier Medical Devices, on April 12.

These devices are even more advanced than Star Trek’s Tricorder because they bypass the doctor. With the XPrize prototypes, the idea was for consumers to make their own diagnosis at home without interacting with any medical professional or facility. “When you think about some of the medical devices that are engineered today, the emphasis is really on the healthcare professional,” said Grant Campany, leader of the Qualcomm Tricorder XPrize competition. “Companies design devices knowing that either a nurse or a doctor is going to be the primary end user of the device. I think where this competition makes a dramatic shift is its focus on the consumer.”

Campany and two XPrize contestants have been invited to participate in the 69th AACC Annual Scientific Meeting & Clinical Lab Expo this summer in San Diego during a special session. XPrize semifinalist Eugene Chan, MD, founder, president, and chief scientific officer of the DNA Medicine Institute (DMI) in Cambridge, Massachusetts will discuss the DMI team’s rHEALTH Sensor. Second-place winner Chung-Kang Peng, PhD, co-director of the Rey Institute for Nonlinear Dynamics in Medicine at the Beth Israel Deaconess Medical Center in Boston and K.-T. Li chair professor of the National Central University in Taoyuan City, Taiwan, also will explain his Dynamical Biomarkers Group Smart Test Kit.

2017 AACC Annual Scientific Meeting

The goals of the special session are to see what these inventors are creating and learn more about their challenges, while letting them know that laboratory professionals are available as a resource, said Shannon Haymond, PhD, associate professor of pathology at Northwestern University Feinberg School of Medicine in Chicago and a symposium moderator. Haymond is also the director of clinical chemistry and mass spectrometry laboratories and laboratory research services, and associate director for the clinical and translational research program at the Ann and Robert H. Lurie Children’s Hospital of Chicago.

“We are interested in new technologies and have the necessary experience to help evaluate and advise on the development and performance of diagnostic tests,” Haymond said. In fact, many AACC members work with or serve as consultants for the in vitro diagnostics industry, but this relationship has not been as robust with startup biotech companies that are developing new diagnostics, she noted.

“Engineering is fantastic,” Haymond said. “Advances in microfluidics, sensors, and the digitization of information are driving the development of exciting new diagnostics like those we’ll see in this session. But that alone does not ensure diagnostic test performance or improved patient care. I think there is a need to join these efforts with clinical and laboratory medicine expertise, and this is one forum in which we’re hoping to do that.”

For the Tricorder XPrize, 34 registered teams out of 300 submissions competed on user experience and accuracy. Qualcomm Tricorder XPrize announced ten finalist teams in 2014 that included the Dynamical Biomarkers Group as well as DMI; Dynamical Biomarkers then advanced to the final round in December 2016 along with Final Frontier Medical Devices. The teams’ devices had to reach at least 70% accuracy in diagnosing 13 health conditions—including anemia, diabetes, urinary tract infection, and pneumonia—to advance to the final round. The winning devices performed diagnostic tests only after querying users about symptoms and employing algorithms to reach a suspected diagnosis.

Dynamical Biomarkers Group, a team of dozens of collaborators in the United States and Taiwan, approached the challenge from the perspective of the lead scientists’ research interest: the continuous collection of biological data. This led the team to explore, for example, ways of diagnosing emphysema by analyzing a person’s continuously monitored respiratory rate or oxygen saturation and looking for changes, perhaps day to day or during exertion. They also explored using electrical impedance to measure breathing and acoustic impedance to measure lung capacity.

Often these ideas required further study to discern whether candidate markers actually correlated with disease, said Andrew Ahn, MD, a hospitalist at Beth Israel Deaconess Hospital in Boston, Massachusetts and lead medical advisor for the team. “That was a big challenge, because we needed some of that clinical data, but we also needed to do this in a short period of time,” he said. The 5-pound weight limit was also a challenge. Initially, the Dynamical Biomarkers Group team worked on single-drop blood tests and an “electronic nose” to analyze breath, but both projects had to be abandoned because of weight.

Final Frontier Medical Devices was led by Basil Harris, MD, PhD, FACEP, a Philadelphia-area emergency physician. This small team was composed entirely of people who have other day jobs, many of them family members, including Harris’s siblings. They developed a device called DxtER. One of its innovations is a non-invasive monitor similar to a pulse oximeter finger clip to measure blood glucose and hemoglobin concentrations, and leukocyte count. Like a pulse oximeter, it detects the absorption of different wavelengths of light, specifically light absorbed by white blood cells or dissolved substances, such as glucose, Harris explained. “We are just taking the finger clip to the next level,” he said, “and the overall simplicity of this solution is what makes it so cool.”

Harris and his collaborators used DxtER on hospital patients with high glucose levels, collecting data as their blood sugar was corrected. The more data collected, the more accurate the monitor became, Harris said. Initially DxtER could only assign patients to a simple range for blood glucose level, such as low, normal, elevated, or markedly elevated. A version currently undergoing a 500-patient clinical trial could get within plus or minus 10 mg/dL of the glucose reference method, though it is early to declare this particular mission accomplished. “We do not want to overstate its abilities, and it is still undergoing clinical testing,” Harris noted.

DxtER diagnoses 34 diseases, said Basil’s sister and team member Julia Harris, MPH, MIA, whose day job is with Tennessee’s Medicaid program. The Harrises hope to raise that number to 100 to 200 diseases before releasing the device commercially. They expect DxtER will help people manage chronic diseases at home and prevent costly, avoidable emergency visits.

“A technology like this could be a triage system initially,” Julia Harris said, perhaps marketed for use by healthcare professionals first, then later directly to consumers. “[It] could also be used in a smart way to take people out of potentially more expensive care settings and give them answers they need at home or at Walgreens or at CVS.”

The Dynamical Biomarkers Group is also planning to commercialize its prototype, initially for use in remote areas with limited medical care. Peng is already working to get support from the Chinese government.

Devices like these will play a critical role in bringing down the cost of healthcare in the United States, as well, Ahn said. “Part of addressing these high costs is focusing more on doing things at home, being proactive rather than reactive, focusing on prevention, and having patients empowered so that they have information and know what to do,” he said.

The Tricorder XPrize was only a starting point, Campany said. “I envision that once the competition is over there’s going to be a strong demand for ways to partner, to actually look at ways in which different technologies can be integrated into these Tricorder-like devices,” Campany said. “I think this is only really the beginning of a whole new future of how devices are going to be designed and engineered with the consumer in mind.”

Laboratory professionals should play a key role in developing these devices because they understand the importance of obtaining real and reliable data, Harris said. “This type of technology is coming,” he said. “This is going to happen whether we are involved or remain on the sidelines. We need clinicians and laboratorians to guide the development and direct the conversation....We need to demand that devices coming to market deliver worthy, medically significant data.”

Julie Kirkwood is a freelance journalist who lives in Rochester, New York. +EMAIL: julkirkwood@gmail.com