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Ground Breaking Human Trial for COVID-19 Ultra-Rapid Breath Test Begins in India

Cleveland based companies, Canary Health Technologies and SmartShape Design, have collaborated to create ASU Detect CV19, an ultra-rapid, highly accurate breath test device for the detection of COVID-19. The digital, hand-held test requires minimal training and can be performed at the point of care without the need of a laboratory. 

Using exhaled volatile organic compounds found in human breath as biomarkers of the virus, ASU Detect CV19 is designed to detect the virus in people that are exhibiting symptoms or asymptomatic. While current available tests measure the viral load in a person to determine if they are infected, Canary’s breath test detects the metabolic response almost immediately after infection.  It is designed to detect the virus and produce a positive or negative result in less than three minutes.

The current ASU Detect CV19 clinical trial taking place in Delhi, India is the first and largest clinical trial using a real-time breath test for the detection of an infectious disease with cloud-based artificial intelligence for pattern recognition as the analytical tool. Trials in the United States are being planned and are due to begin before the end of 2020. If the trial is successful, Canary will move quickly to apply for fast-track regulatory approval while continuing to trial the test in real-world settings such as airports, resorts and other high traffic areas.

Canary’s CEO and inventor of the breath sensing technology, Raj Reddy, believes Canary’s breath diagnostic platform will be the future of COVID-19 detection, as well as many other diseases. According to Reddy, “Our cutting-edge technology enables easy, rapid testing every few days in order to optimize safety in workplaces and other settings. Our unique strength will be our ability to detect COVID-19 in under three minutes before the onset of symptoms which will be critical in reducing transmission and ultimately putting an end to this pandemic.”

Canary was able to develop this novel test for COVID 19 at top speed because the platform was already in advanced development to detect early stage lung cancer.  By February 2020, it was clear the pandemic would lead to major global disruption, and Canary quickly pivoted to design an ultra-rapid test that can be used to mitigate transmission and open the economy.  Canary’s scientists and engineers focused on developing a mobile test powered by cloud-based artificial intelligence that can be used for mass screening and monitoring, all in real-time.

Supporting Canary with industrial design and manufacturing has been both personally and professionally rewarding for SmartShape CEO & Founder Mike Maczuzak, “As a consultancy, SmartShape helps invent, design and develop innovative new products across a broad spectrum of verticals, from medical devices to industrial and consumer products. We’re involved with many emerging technologies that are exciting, but when we can help develop a product that will have such an impact on peoples’ lives, and even save lives, that is incredibly satisfying. Everyone has been affected by this global pandemic and to know that our team will have contributed to solving it – that really fuels my passion for healthcare innovation.”

The multi-disciplinary team of scientists, engineers, industrial designers and tooling experts working across continents were able to turn a next-generation sensor technology into an easy to use device with unprecedented speed.  Mark Cartellone, SmartShape Design's Director of Engineering, “The ability to transition the project from conceptual designs quickly into complete engineering design, tooling and eliver production ready parts in less than 6 months is a credit to the national teams.  This afforded Canary production testing units in a rapid, efficient manner.” 

Canary’s powerful breath analysis platform is also in development for the diagnosis of cancer, infectious disease and inflammatory disease. In 2019, a clinical trial in Canada demonstrated the platform can detect lung cancer with high sensitivity and specificity. Proof of concept and pivotal trials for several high-burden diseases are being planned in the US and Asia in 2021.  Trials to diagnose rheumatoid arthritis and monitor effectiveness of therapy are due to start in New York and Hong Kong in early 2021. Canary has also performed bench studies for tuberculosis with promising results, indicating that a highly sensitive breath test for TB detection is within reach.