The system, named Aura, is completely noninvasive and uses the company's wearable medical smartwatches, software, and artificial intelligence (AI) capabilities. Aura, says the company, 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.
Early last year the company and BARDA's Division of Research, Innovation and Ventures (DRIVe) began to develop a digital biomarker that predicts respiratory infections. Preliminary findings, says the company, have been promising, showing a strong correlation between viral shedding and changes in a person's physiology. Now it will be sponsored to run a validation trial specific to early detection of COVID-19.
The aim of the validation trial is to validate the company'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 company's E4 medical-grade research wearable wristband for 30 days, during which their physiological data will be reviewed against daily nasopharyngeal (NP) samples and a daily qRT-PCR swab, ensuring the highest ground truth.