Clinical OMICS

MAR-APR 2019

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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12 Clinical OMICs March/April 2019 www.clinicalomics.com the insights that smartphone technology can provide with those of clinicians and therapists. Choudhury is also an asso- ciate professor of information science at Cornell University where she runs the People-Aware Computing Lab. "This is a domain where most diagnosis is done either through obser- vation or patient-self-reporting," she said. Choudhury's goal is to make diagnosis more objective and quantifiable. "That's where biomarkers come in." HealthRhythms uses smartphone sensor data to automat- ically measure patterns of behavior. In 2017, the company received a $2.1 million grant from the NIH to continue investigating smartphone-based behavioral health inter- ventions. Currently, the company's applications focus on measuring biomarkers of depression, including how a per- son uses their phone, their number of steps, location (at home, work, or out in the community), and sleep time. These data help gen- erate scores of sociability, mobility, and activity. The company is cur- rently performing a clini- cal trial with researchers at the University of Utah to look at interventions based on these data, which can inform researchers if peo- ple are becoming more iso- lated, if their energy levels are decreasing, and if they are sleeping poorly—all indications of worsening depression. "We can actually track change in mental health," Choud- hury noted, adding that the challenge she and other clinical researchers face is how to turn vast amounts of continuously collected data into packaged results physicians can—and will—use the data. The question, she said, is how can these data be delivered in the most clinically efficient way so that doctors can use it to improve the efficiency of their practice. "Most physicians don't want to see data unless something is wrong," Choudhury said. "The delivery has to be targeted." Collier even suggested that digital biomarkers may require new training for medical professionals. "This is more data than we have ever had," he said. Counting Steps in Patients Digital biomarkers also promise to change in-patient care. An ankle-worn step tracker by modus health, called the StepWatch, received FDA clearance more than 15 years ago. "Our goal is to become part of routine clinical care world- wide," said CEO Teri Rosenbaum-Chou, Ph.D. More wear- able device makers are likely to pursue FDA clearance in the future, opening up new research opportunities. While the FDA determined the StepWatch is safe for use, and some devices, depending on their classification, can be used in the context of clinical decision-making, they are not, however, used to diagnose or treat disease. In 2018, the AppleWatch with EKG and abnormal heart rhythm indicator received FDA clearance, followed in 2019 by the Study Watch with ECG by Verily—a subsidiary of Alphabet, Google's parent company—that is available only to researchers. StepWatch's most recent version is Bluetooth-enabled, which makes it more attractive for research studies. In fact, the company customized a mobile app to use with its Step- Watch4 for use in a small clinical trial looking at intravenous infusion of a drug to treat children with Duchenne muscular dystrophy. A 2017 study led by researchers at the University of California, Los Angeles showed the StepWatch accurately measured "community ambulation" in this population in which strides per day and frequency of strides correlated with condition status. Rosenbaum-Chou said the StepWatch uses highly accurate algorithms for quantifying walking. "Accuracy and reliability are very important to digital bio- markers because filtering out the noise is required to cap- ture clinically relevant change." The StepWatch was developed using patients who had difficulty walking, patients in which other consumer-avail- able activity trackers often did not record steps taken. These monitors have the potential to improve the efficiency with which nurses and other caregivers in hospitals triage patients after surgery. Both in hospitals and after discharge, patients recover from surgery more quickly if they are able to walk around. "The more patients walk before they leave (continued from previous page) Teri Rosenbaum-Chou, CEO modus health The StepWatch easily attaches to a patients' ankle while in the hospital.

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