Concept: American startup, Ava has announced the launch of COVID-19: Rapid Early Detection (COVID-RED) clinical trial, the first study of its kind to test whether a wearable device can detect a COVID-19 infection in real-time and alert people to get tested or self-isolate before showing symptoms. COVI-GAPP’s study claims that Ava’s algorithm can detect COVID-19 virus with up to 71% accuracy, at least two days before the symptom onset. COVID-RED clinical trial takes the research to the next step by testing the real-time efficacy of Ava’s device that is currently used primarily for fertility tracking, to identify the virus during its pre-symptomatic phase.

Nature of Disruption: Ava leverages its sensor’s ability to track menstrual cycle changes in multiple physiological parameters including skin temperature for the early detection of COVID-19 positive cases. During the testing stage, participants wear the Ava fertility tracker for up to nine months, while they sleep in the night, and upon waking, they will be able to see an AI-generated indicator reflecting their overall health status. Based on changes in their physiological parameters, the three possible indicators displayed on the device are; detection of no change in wellness; minor changes in symptoms with the suggestion to self-isolate; changes in symptoms, and detection of biophysical data to signal a potential COVID-19 infection. The asymptomatic participants can get identified as potentially ill by the app with access to a diagnostic test, ideally enabling them to self-isolate and prevent infecting others. Tests are being conducted to detect infection in real-time, providing bracelet wearers with daily updates about their health and well-being.

Outlook: Identifying virus carriers as early as possible is a big challenge in the fight against COVID-19. COVID-19 symptoms occur late due to which the virus spreads unknowingly, making effective tracking difficult. The situation has become more difficult by the emergence of virus mutations that seem to spread more quickly from person to person than the original strain. More than 20,000 participants of all genders and across general and high-risk populations are supposed to get access to an Ava bracelet. Ava expects its algorithm to further improve its accuracy for better detection of the COVID-19 virus.  COVID-RED is funded by the Innovative Medicines Initiative 2 Joint Undertaking, the COVID-RED consortium is a collaboration bringing together global experts from the private and public sectors. Members of the consortium include Ava, Julius Clinical Research, Labormedizinisches Zentrum Dr Risch Ostschweiz, Roche Diagnostics Nederland (Roche), Stichting Sanquin Bloedvoorziening (Sanquin), Takeda Pharmaceuticals International (Takeda), University College London (UCL), Universitair Medisch Centrum Utrecht (UMC Utrecht), and Vive.

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