Emerging Tests

New Collaboration Seeks to Develop Handheld Breathalyzer Test for COVID-19

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’s the lowdown:

The Current COVID-19 DX Test Market

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 COVID-19. 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. But what if there were a way to provide mass testing to asymptomatic people without diverting badly needed testing resources?

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’s the idea behind the new research collaboration between Canary Health Technologies and Divoc Laboratories.

The Collaboration

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 lab focused on providing a digitally empowered integrated approach to diagnostics.

Announced on Nov. 30, the objective of the new collaboration is to develop and validate a hand-held digital breath test called ASU Detect CV19 which uses next-generation nanosensors and cloud-based artificial intelligence analysis to detect the SARS-CoV-2 virus in less than three minutes. The test is scalable, low cost and viable for use at the point of care for mass screening of both the symptomatic and asymptomatic.

Yeah, but will it work? To answer that question, the partners will perform a large clinical trial on 750 participants, some but not all of whom are positive for COVID-19. Participants will be asked to breathe into the ASU device for three minutes. The 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 were expected before the end of the year.

If the trial is successful, the plan calls for Canary to 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-density areas.

Other COVID-19 Diagnostic Products for Testing the Asymptomatic

Earlier this year, the FDA revised its templates to allow test makers whose products have already received EUA for testing symptomatic people to apply for expansion of that EUA to cover use of the product for screening of asymptomatic individuals. Products that have received reissued EUA covering asymptomatic screening include:

  • LabCorp’s COVID-19 RT-PCR test;
  • LabCorp’s Pixel by LabCorp COVID-19 Test Home Collection Kit;
  • Hologic’s Aptima SARS-CoV-2 assay;
  • Hologic’s Panther Fusion SARS-CoV-2 Assay;
  • Helix OpCo’s Helix COVID-19 Test;
  • DxTerity Diagnostics’ DxTerity SARS-CoV-2 RT-PCR CE Test;
  • Centogene’s CentoSure SARS-CoV-2 RT-PCR Assay;
  • Gravity Diagnostics’ Gravity Diagnostics SARS-CoV-2 RT-PCR Assay; and
  • Kaiser Permanente Mid-Atlantic States’ KPMAS COVID-19 Test.

Takeaway

While the new collaboration between Canary Health Technologies and Divoc Laboratories on handheld breathalyzer testing is hardly the first initiative to develop COVID-19 test products for the asymptomatic, what makes it unique is its modality. Rather than seeking to expand a molecular, antigen or antibodies test to cover screening of asymptomatic individuals, the partners are attempting to engineer a test specifically dedicated to this objective.


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