CLEVELAND—Canary Health Technologies, in a collaboration with SmartShape Design, has created ASU Detect CV19 — an ultra-rapid, breath test device for the detection of COVID-19 that is heading for human trial in Delhi, India.
ASU Detect CV19 is a highly accurate handheld digital test which requires minimal training and can be performed at the point of care, with no need for a laboratory. This is reportedly the first and largest clinical trial for a real-time breath test for the detection of an infectious disease, using cloud-based artificial intelligence for pattern recognition as the analytical tool.
With exhaled volatile organic compounds found in human breath serving as biomarkers of the SARS-CoV-2 virus, the diagnostic is designed to detect virus in both symptomatic and asymptomatic patients. Currently available tests can measure the viral load in a person to determine if they are infected, but Canary’s breath test has an advantage: it’s said to detect the metabolic response almost immediately after infection.
Raj Reddy, chief executive officer of Canary Health Technologies and inventor of the breath sensing technology, believes that Canary’s breath diagnostic platform will be the future of COVID-19 detection, as well as many other diseases.
“Our cutting-edge technology enables easy, rapid testing every few days in order to optimize safety in workplaces and other settings,” Reddy noted. “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 capable of developing this COVID-19 diagnostic at top speed because the platform it’s built on was already in advanced development for detecting early stage lung cancer. In February, the company pivoted to design an ultra-rapid COVID-19 test. Canary’s scientists and engineers focused on developing a mobile test for mass screening and monitoring in real-time.
“We’re involved with many exciting and emerging technologies, but when we can help develop a product that will impact and even save lives, that is incredibly satisfying. Everyone has been affected by this global pandemic and to know our team will have contributed to solving it — that really fuels my passion for healthcare innovation,” said Mike Maczuzak, chief executive officer and founder of SmartShape.
Trials in the US are due to begin before the end of 2020. If the trial in India is successful, Canary says that the company will move quickly on applications for fast-track regulatory approval, as well as continuing to trial its test in real-world settings like airports, resorts and other areas with high traffic.
Canary’s breath analysis platform is in development for the diagnosis of cancer, infectious disease and inflammatory disease. In 2019, a Canadian clinical trial demonstrated that the platform can detect lung cancer with high sensitivity and specificity. Trials to diagnose rheumatoid arthritis and monitor effectiveness of therapy are due to start in New York and Hong Kong in early 2021. Canary also reports positive results from bench studies for tuberculosis, indicating that a breath test for tuberculosis detection is within reach.