Global Collaboration Seeks to Develop Game-Changing Handheld COVID-19 Breathalyzer Test

A handheld, easy-to-use breathalyzer device capable of accurately detecting COVID-19 at the point of care would represent a 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 to test the idea’s viability. Here’s a look at the deal and its potential significance. A New COVID-19 Testing Modality Rapid and accurate point-of-care testing performed on a mass basis, including both the symptomatic and asymptomatic, is crucial to containing coronavirus spread. However, only a few of the COVID-19 diagnostic tests that have hit the U.S. market since the pandemic began have received regulatory approval for testing people who are asymptomatic. People displaying symptoms of illness should be the priority when testing resources are in scarce supply. By the same token, the coronavirus is mostly spread by persons who don’t have symptoms. That makes it imperative to develop a method of providing mass testing to asymptomatic people without diverting resources desperately needed for testing the symptomatic. The Potential for VOCs Testing Current COVID-19 diagnostics, including laboratory developed tests (LDTs), are based molecular, antibodies or antigen detection. A potential solution is to develop a new modality using a different biomarker to detect the virus. One 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 Announced on Nov. 30, the objective of the collaboration between Canary and Divoc is to develop and validate a handheld 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 lab 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 are carrying out 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 don’t have the virus. They’ll 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. 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. Here’s a summary of other key strategic diagnostic deals announced in January 2021: STRATEGIC ALLIANCES, PARTNERSHIPS & COLLABORATIONS

Partner 1	Partner(s) 2+	Deal Summary
Invitae	Bristol Myers Squibb + Janssen Research & Development + Novartis + Genentech	Objective: Develop NGS-based panel for standardized minimal residual disease (MRD) detection in acute myeloid leukemia (AML) patients Dynamic: Leverage Invitae’s anchored multiplex PCR chemistry to standardize MRD measurement methods for use in clinical trials assessing effectiveness of AML treatments and as biomarker for predicting patient survival after treatment
Invitae	Pacific Biosciences	Objective: Develop production-scale, high-throughput whole-genome sequencing (WGS) platform for clinical use Dynamic: Multi-year collaboration to leverage PacBio’s HiFi long-read next-generation sequencing to develop cost-effective assays and make WGS-powered analysis more accessible for carrier screening, evaluating immune system responses and diagnosing other heritable disease Companies currently collaborating to use HiFi sequencing to develop new epilepsy diagnostics
Illumina	Helix	Objective: Track new SARS-CoV-2 strains in U.S., including B.1.1.7 variant first identified in U.K. Dynamic: With CDC support, Helix to analyze positive samples with S gene dropout on their PCR-based COVID-19 assay; Illumina to then use its COVIDSeq test to sequence a subset of anonymized samples to determine whether dropout is due to strain B.1.1.7 or a different mutation
Oxford Immunotec	Valneva	Objective: Perform T-cell testing for Valneva’s COVID-19 vaccine candidate VLA2001 Dynamic: Oxford Immunotec (which is being acquired by PerkinElmer) to use its research-use-only T-Spot Discovery SARC-CoV-2 test on participants getting VLA2001 vaccine
Tempus	A2 Biotherapeutics	Objective: Develop companion diagnostic test for Tmod, A2’s loss of heterozygosity (LOH)-targeted cell therapy platform Dynamic: LOH CDx assay to run on Tempus’ xT sequencing platform to identify patients eligible for Tmod Partnership may expand to include development of additional CDx tests for A2’s other clinical development programs
Qiagen	Personal Genome Diagnostics	Objective: Provide clinical decision support to users of PGDx’s cancer genomic profiling tests Dynamic: Non-exclusive agreement offering labs that purchase PGDx Elio oncology products option to receive standardized reporting from Qiagen based on professional guidelines to facilitate case review Labs to also get access to Qiagen’s QCI Interpret One for rapid, evidence-based variant interpretation and reporting for NGS tests
Biodesix	HiberCell	Objective: Develop enzyme-linked immunosorbent assay (ELISA) for use as companion diagnostic test Dynamic: Biodesix to develop CDx test to select patients for enrollment in future HiberCell clinical trials
Resolution Bioscience	Mirati Therapeutics	Objective: Develop CDx to identify non-small cell lung cancer (NSCLC) patients who may benefit from Mirati’s investigational KRAS G12C inhibitor therapy Dynamic: Leverage Resolution’s ctDx liquid biopsy technology to identify NSCLC patient candidates
Grail	Amgen + AstraZeneca + Bristol Myers Squibb	Objective: Evaluate Grail’s methylation-based technology for detecting MRD in early-stage cancer patients Dynamic: Grail to use results to adapt its targeted methylation platform for cancer screening for use to screen cancer patient’s blood for signs of MRD, a simpler solution not requiring upfront tissue samples or personalized assays
Clear Labs	Integrated DNA Technologies	Objective: Automate and improve accuracy of Clear Dx SARS-CoV-2 assay Dynamic: Expansion of previous agreement covering oligonucleotide supply agreement for food safety testing
Genuity Science	Emory University	Objective: Develop population clinicogenomic database to support biomarker and drug target discovery and validation Dynamic: Partnership to focus initially on neurogenerative conditions, including Alzheimer’s and Parkinson’s
CareDx	IDbyDNA	Objective: Develop metagenomic infectious disease testing for transplant patients Dynamic: Exclusive partnership to develop and commercialize AlloID, infectious disease test tailored to organ transplant donors and recipients that identifies over 100 pathogens, as well as drug resistance in viruses and bacteria
Sera Prognostics	Anthem and its HealthCore insurer subsidiary	Objective: Determine if Sera’s PreTRM test can lead to improved health for newborns and mothers Dynamic: Perform study to evaluate how pairing PreTRM test with clinical interventions may mitigate preterm birth risk, improve neonatal outcomes and reduce overall healthcare costs in this population
4D Lifetec	VolitionRx	Objective: Determine whether combining each firm’s respective assay technology can improve identification of individuals with early-stage cancer Dynamic: Perform clinical validation trial using 4D’s 4D Lifetest in combination with Volition’s NuQ technology in a set of lung cancer clinical samples

DISTRIBUTION, SALES & MARKETING AGREEMENTS

Product Owner	Distributor	Deal Summary
GenapSys	Bioron	Products: GenapSys’ sequencing system Territories: Germany
Phasefocus	Cellink	Products: Phasefocus’ Livecyte high-content live-cell imaging platform Territory: Undisclosed Cellink to offer Livecyte in combination with its own bioprinters, liquid handlers and bioinks products
Mission Bio	Bioké	Products: Mission Bio’s Tapestri single-cell multi-omics platform Territory: Netherlands, Belgium, Luxembourg
LevitasBio	Bioké	Products: LevitasBio’s LeviCell cell separation system Territory: Netherlands, Belgium, Luxembourg
PixCell Medical	Triolab	Products: PixCell’s HemoScreen Hematology Analyzer Territory: Sweden Exclusive
Access Bio	Everlywell	Products: Access Bio’s CareStart COVID-19 antigen test Territory: U.S. Test to be distributed to organizations in need
Curetis (OpGen subsidiary)	Annar Health Technology	Products: Curetis Unyvero A50 instrument and Unyvero infectious disease diagnostic application cartridges Territory: Colombia 3-year deal with 1-year renewal options under which Annar commits to purchase at least 10 Unyvero instruments and a large number of Unyvero cartridges

LICENSES

Licensor	Licensee	Deal Summary
Procter & Gamble	Rhinostics	Rhinostics licenses plastics technology for novel nasal swab to relieve COVID-19 testing supplies bottlenecks

SUPPLY, SERVICE, TESTING & MANUFACTURING AGREEMENTS

Supplier/Servicer	Client/User	Deal Summary
Nexus Dx	Osang Healthcare	Nexus Dx to manufacture Osang’s GeneFinder COVID-19 Plus RealAmp Kit kit at its San Diego facility