Breath

A Window Into Your Health

Every exhale carries volatile compounds reflecting metabolism, infection, inflammation, and disease. Breath diagnostics decodes this real-time biochemical fingerprint to deliver fast, non-invasive health insights. It enables early detection, continuous monitoring, and personalized care—without needles or labs—transforming healthcare from reactive testing to proactive prevention, simply by breathing.

Redefining what’s possible at the point of care—diagnosing disease through two-minute breath tests.

As healthcare systems are pushed to diagnose earlier, faster, and more accurately, traditional lab-bound diagnostics struggle to scale with the speed and efficiency modern care demands. The need for more accessible screening for efficient clinical intervention—without adding complexity for clinicians—is clear.

Our patented CLARION point-of-care breath diagnostics platform delivers real-time, lab-grade molecular analysis in a first-of-its-kind portable platform. By combining deep-tech and AI, we bring high-precision diagnostics out of the lab and into everyday care by turning a simple breath sample into actionable insights. More than a device, CLARION is designed to evolve. As biomarkers expand and AI models advance, it supports new screening, triage, and monitoring applications without changing clinical workflows, for a future defined by early detection, decentralized care, and real-time decision-making.

Clinical

Objectives

Infectious Diseases

Respiratory and systemic infections remain among the most common reasons for urgent medical visits worldwide, yet distinguishing between viral and bacterial causes is often difficult based on symptoms alone. This diagnostic uncertainty can lead to delayed treatment, inappropriate antibiotic prescribing, and increased healthcare burden. In addition, rapidly identifying specific viral infections such as influenza, COVID, or rhinovirus is critical for guiding isolation measures, antiviral use, and outbreak control.

The CLARION Diagnostic Difference

CLARION offers a two-minute, point-of-care breath test designed to detect pathogen-associated volatile organic compound (VOC) signatures and discriminate viral from bacterial infections, while further differentiating among major viral illnesses such as influenza, COVID, and rhinovirus. Unlike traditional lab-based or invasive diagnostics, CLARION is simple and comfortable for patients, requires minimal training to administer, and can be deployed across a wide range of screening environments, from hospitals and clinics to urgent care centers and community settings. Its rapid turnaround and scalable workflow also make it well suited for high-throughput testing, supporting faster diagnosis, targeted treatment, and stronger infection control.

We validated this approach through a clinical study conducted from November 2025 to June 2026 in collaboration with the University of South Florida and funded by the Defense Threat Reduction Agency (DTRA) and the Defense Innovation Unit (DIU). The figures below present the first diagnostic models from this study and their performance in distinguishing viral from bacterial infections and identifying specific viral illnesses from exhaled breath.

Tuberculosis & Malaria

In low- and middle-income regions, malaria and tuberculosis remain among the world's deadliest infectious diseases. The challenge is not a lack of treatment, but a lack of timely diagnosis. Many patients face long travel distances, limited laboratory access, and delays that let disease worsen and spread before care can begin.

Current diagnostics are often slow, invasive, or difficult to scale. Malaria testing depends on consumable supplies and trained personnel, while TB diagnosis may require sputum collection, imaging, or specialized molecular tools rarely available outside major hospitals. Too often, detection comes too late, costing lives and livelihoods.

The CLARION Diagnostic Difference

By detecting disease-specific volatile organic compound (VOC) biomarkers in exhaled breath, CLARION offers a rapid, non-invasive way to diagnose malaria and tuberculosis at the point of care, on a portable platform built for low-cost testing outside the traditional laboratory.

We validated this approach in the field through the MATTHIAS study (MAlaria and Tuberculosis breaTH dIAgnoStics), conducted from August to December 2025 at Makélékélé Hospital in Brazzaville, Republic of Congo. Led by Detect-ION in collaboration with Labyrinth Global Health and the Laboratoire National de Santé Publique, the Republic of Congo's national public health laboratory, and supported by the Gates Foundation, the study is the first clinical validation of breath-based VOC diagnostics for malaria and TB in a co-endemic, resource-limited setting. The figures below present the first diagnostic models from this study and their performance in distinguishing disease-positive from disease-negative breath samples.

MATTHIAS Study: August 2025 - December 2025

Lung Cancer: Early Detection, Artificially Limited

Lung cancer remains one of the deadliest cancers not because it is untreatable, but because it is usually detected too late. Nearly three out of four patients diagnosed at Stage III or IV die within five years, driven largely by delayed diagnosis and limited access to early screening.

Early-stage disease is often asymptomatic. While low-dose CT (LDCT) screening reduces mortality, its impact is constrained by cost, infrastructure requirements, and restrictive eligibility criteria that limit use to narrowly defined high-risk populations. Even among eligible patients, uptake is low, and access disparities further reduce effectiveness.

As a result, screening is effectively rationed. Many at-risk individuals remain unscreened, while false positives and incidental findings from LDCT add cost and clinical complexity. Clinicians often default to imaging only after symptoms appear, when disease is already advanced and harder to treat.

The CLARION Diagnostic Difference

By detecting cancer-associated volatile organic compound (VOC) biomarkers linked to early lymph node spread, CLARION provides a rapid, non-invasive way to assess lung cancer risk in minutes — without radiation, costly imaging systems, or narrow screening rules.

The result is a more affordable and accessible test that can expand screening beyond traditional high-risk profile criteria to patients who are often missed until symptoms appear at later stages. This supports earlier treatment, fewer unnecessary scans, and better outcomes through broader access to early detection.

Pseudomonas aeruginosa

In immunocompromised patients—those with cancer, organ transplants, diabetes, cystic fibrosis, or COPD—worsening respiratory symptoms often raise concern for Pseudomonas aeruginosa, a leading cause of severe hospital-acquired pneumonia. Because early differentiation is impossible with existing tools, clinicians default to imaging, broad laboratory workups, and immediate empiric broad-spectrum antibiotics.

Definitive diagnosis remains slow and imprecise. Non-invasive respiratory samples are frequently contaminated or non-diagnostic. When uncertainty persists, clinicians escalate to bronchoscopy with bronchoalveolar lavage (BAL), an invasive, costly procedure requiring sedation, associated with lower blood oxygen levels, and often poorly tolerated by already fragile patients. Even then, cultures take 48–72 hours to result, with additional delays for antibiotic susceptibility testing.

During this diagnostic gap, patients may clinically deteriorate, hospital stays lengthen, and clinicians are forced to maintain unnecessary or overly aggressive antibiotic regimens because today’s diagnostics cannot reliably distinguish benign colonization from true invasive infection.

The CLARION Diagnostic Difference

By detecting pathogen-specific volatile organic compound (VOC) biomarkers and correlating them with disease severity, CLARION enables rapid, non-invasive determination of whether P. aeruginosa is present—and whether it is actively driving disease—without bronchoscopy, sedation, or prolonged diagnostic uncertainty.

The result is earlier targeted therapy, confident antibiotic de-escalation, reduced length of stay, and a scalable diagnostic workflow that aligns speed, precision, and patient-centered care in a way current standards cannot.

Breath

Infectious Diseases Study Completed

Infectious Diseases

The CLARION Diagnostic Difference

Tuberculosis & Malaria Study Completed

Tuberculosis & Malaria

The CLARION Diagnostic Difference

Lung Cancer Study Ongoing

Lung Cancer: Early Detection, Artificially Limited

The CLARION Diagnostic Difference

Pseudomonas aeruginosa (PA) Study Ongoing

Pseudomonas aeruginosa

The CLARION Diagnostic Difference