"This product introduces a new paradigm by 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," says Empatica CEO Matteo Lai. "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 approval of Aura as a medical product for use by people at risk of contracting COVID-19."
BARDA Acting Director, Gary Disbrow, Ph.D.,adds, "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."
Such early detection of disease, says the company, can protect frontline workers, reduce spread, and improve the overall public health response as lockdowns ease globally. CDC estimates suggest that 35% of infections are asymptomatic, making contact tracing and containment of the virus a challenge.
Meanwhile, the most infectious period could be one to three days before symptoms start, so even those patients who eventually display symptoms can still infect other people they interact with, before realizing they are ill. Digital biomarkers like Aura, says the company, can help efficiently triage patients, enabling more effective care and prioritization of cases, and potentially saving lives.