Pairing of VOC Breathalyzer Testing and AI Cloud-Based Analysis Could Be Coronavirus Game Changer

A handheld, easy-to-use breathalyzer device capable of accurately detecting COVID-19 at the point of care would represent a major breakthrough in the effort to contain the spread of the virus. That vision may now be closer to reality thanks to a new international collaboration established to perform a massive clinical trial to test the idea. Here is a briefing on the deal and its potential significance:

The Diagnostic Challenge

All agree that rapid and accurate point-of-care testing performed on a mass basis, including both the symptomatic and asymptomatic, is crucial to containing the spread of coronavirus. However, only a few of the COVID-19 diagnostic tests that have hit the market since the pandemic began have received regulatory approval for testing people who are asymptomatic.

Focusing on the symptomatic is completely understandable. After all, people displaying symptoms of illness should be the priority when testing resources are in scarce supply. By the same token, as the U.S. Centers for Disease Control and Prevention (CDC) reports, the coronavirus is mostly spread by persons who do not have symptoms. Accordingly, what is need is a method of providing mass testing to asymptomatic people without diverting resources that are desperately needed for testing the symptomatic?

A New COVID-19 Testing Modality

Current COVID-19 diagnostics, including laboratory developed tests (LDTs), are based molecular, antibodies or antigen detection. So, a potential solution would be to develop a new modality using a different biomarker to detect the virus. One biomarker candidate is exhaled volatile organic compounds (VOCs) that could be detected via a rapid breath test. And that is the idea behind the new research collaboration between Canary Health Technologies and Divoc Laboratories.

Instead of measuring the viral load the way current tests do, breath tests detect COVID-19 by evaluating metabolic response nearly immediately after infection. The modality is based on the fact that like influenza, rhinovirus, SARS, MERS and other viral infections, coronavirus increases oxidative stress releasing highly reactive free radicals that serve as powerful biomarkers contained in an infected person’s exhaled breath. Moreover, each virus has its own unique VOC signature.

The Collaboration

Announced on Nov. 30, the objective of the collaboration between Canary and Divoc is to develop and validate a hand-held digital breath test for coronavirus. Canary is a U.S.-based medical technology company that uses proven biomarkers, proprietary nanosensors and AI-powered software to map and uncover data in human breath to detect cancers, inflammatory and infectious diseases on a rapid basis. Divoc is a Dehli-based laboratory focused on providing a digitally empowered integrated approach to diagnostics.

The new Canary test, called ASU Detect CV19, uses next-generation, highly sensitive nanosensors to collect breath samples which are then analyzed through the use of cloud-based artificial intelligence capable of detecting the SARS-CoV-2 virus in less than three minutes. In addition to being disposable, which mitigates the risk of infection, the Canary test is scalable, low cost and viable for use at the point of care for mass screening of both the symptomatic and asymptomatic.

The Next Steps

The idea is exciting. The key question, of course, is whether it will actually work. In 2019, a clinical trial in Canada demonstrated that the Canary breath analysis platform is capable of detecting lung cancer with high sensitivity and specificity. To validate the concept for use with coronavirus, the partners will perform what they describe as the first and largest clinical trial using a real-time breath test using cloud-based artificial intelligence for pattern recognition to detect an infectious disease.

To be performed in Dehli, the trial researchers will collect breath samples from 750 people, including both COVID-19-positive patients and patients who do not have the virus. They will be asked to breathe for three minutes into the device. The ASU device will then translate their breath biomarkers into electronic signals which will be transmitted to a centralized “lab in the cloud” for analysis. Preliminary results could come as early as January. The partners also plan to start parallel trials in the U.S. and Europe.

If the trial is successful, Canary plans to seek fast-track regulatory approval in India, the U.S. and other markets while continuing to trial the test in real-world settings such as airports, resorts and other high-density areas.

Takeaway

The combination of VOC technology and cloud-based AI analysis could be the answer to the country’s and the world’s need for rapid, point-of-care COVID-19 screening of the asymptomatic. In addition to its detection capabilities, the platform carries the potential for use in real-time surveillance for disease monitoring, as well as track and trace initiatives. It would also empower public health authorities to identify COVID-19 hotspots as they form and take immediate responsive actions. “This is next-generation technology and has the ability to completely revolutionize testing for COVID-19 and play a critical role in stopping the spread of the virus,” notes Dr. Kanav Kahol, CEO of Divoc and a renowned healthcare innovator. Fingers crossed that trials validate the concept