Wearable System Detects COVID-19 Before Symptoms Appear

(Boston, MA, USA), an MIT spinoff, will validate the early warning system for COVID-19 and other respiratory infections using its wearable sensors and proprietary algorithm. The system, named Aura, is completely non-invasive, utilizing Empatica's medical smartwatches, software, and artificial intelligence capabilities. Aura will enable continuous and real-time insight into the likelihood of SARS-CoV-2 infection before symptoms present, and send a warning to the user and their healthcare provider.

Empatica will validate the system in partnership with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services (HHS). In February 2019, Empatica and BARDA's Division of Research, Innovation and Ventures (DRIVe) began to develop a digital biomarker that predicts respiratory infections. Preliminary findings have been promising, showing a strong correlation between viral shedding and changes in a person's physiology. Empatica will now be sponsored to run a validation trial specific to early detection of COVID-19. The aim is to validate Empatica's algorithm in real-life settings, with the participation of healthcare workers who are exposed to a high viral load while treating hospitalized COVID-19 patients. They will wear the E4, Empatica's medical-grade research wearable wristband, for 30 days, and their physiological data will be reviewed against daily nasopharyngeal (NP) samples and a daily qRT-PCR swab, ensuring the highest ground truth.

“We are very proud to join forces with BARDA to help improve the health and safety of millions of Americans going back to work,” said Empatica CEO Matteo Lai. “This product introduces a new paradigm: empowering individuals and institutions with smart health monitoring, so that they will know early when they need to self-isolate and take care of themselves. Without BARDA's leadership and foresight over the past year, our early detection algorithm would not have reached this pivotal stage of clinical validation, which will accelerate our request for FDA's approval of Aura as a medical product for use by people at risk of contracting COVID-19.”

“We anticipate that access to real-time and actionable health information will empower people to seek medical advice and care sooner, or to adopt behavioral changes such as temporary self-isolation that can help reduce the spread of COVID-19 and similar infections,” said BARDA Acting Director, Gary Disbrow, Ph.D.

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