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BARDA and Empatica forge new partnership to develop an early monitoring platform to identify COVID-19 infection

BARDA Response

BARDA and Empatica embark on a new partnership to develop and seek U.S. Food and Drug Administration’s Emergency Use Authorization for Aura, a wearable system and algorithm that can serve as an early warning platform for COVID-19 infections.

This system will utilize a wearable physiological monitor, Empatica’s E4 wristband device, to detect early signs of infection in individuals. Study participants also will self-collect daily nasal swabs, self-report symptoms, and self-collect daily saturated oxygen read-outs for analysis by Empatica. All data will be used to fine-tune and validate Empatica’s early diagnostic algorithm, which will provide a probability of infection.

The results will be shared with the user via a mobile application and a caregiver through a web dashboard. The overall goal of the platform is to provide an early warning to COVID-19 contagion, helping reduce the transmission of infected individuals and save lives.

Individuals infected with SARS-CoV-2 may only seek diagnostic tests once they begin exhibiting symptoms. Empatica aims to disrupt this health-care paradigm by detecting infection in individuals before the onset of symptoms. This project will leverage data from a previous partnership with BARDA on early detection of respiratory infection, and include a clinical study monitoring at-risk healthcare workers for COVID-19. The goal is to alert healthcare workers and patients to infection early, preventing further spread by allowing for early self-quarantine, treatment, and care.

This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.

About the Company:

The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.

Empatica is a digital health company that designs and develops medical wearables, software and digital biomarkers, providing an AI-enabled platform to advance the health monitoring, forecasting, treatment and research of medical conditions. A pioneer in the enablement of continuous, unobtrusive patient monitoring, Empatica's platform uses a combination of biosensors to detect features of human physiology that are distilled in AI-based algorithms and can remotely monitor autonomic activity, movement, sleep and cardiac activity. Empatica's devices are FDA cleared and CE-marked and have been sold to thousands of companies and institutional partners for clinical trials, health monitoring, and research, examining stress, sleep, epilepsy, migraine, depression, addiction and many other conditions. Their upcoming EmbracePlus device has been built to monitor the health of astronauts on NASA's journeys to Mars, but will also be used to monitor the health of individuals here on Earth.

Last Updated: June 19, 2020