The Technology
Behind OneBreath™
At Breath Diagnostics, our innovative OneBreath™ technology revolutionizes disease screening. By capturing and chemically transforming volatile organic compounds (VOCs) in a patient’s breath, we deliver highly accurate, rapid, and cost-effective diagnostics—without radiation or invasive procedures.
OneBreath™ harnesses the power of your breath to unlock critical diagnostic information.
Unlike conventional screening methods that rely on imaging or invasive tests, our system uses a proprietary microreactor to chemically derivatize VOCs—the biomarkers linked to lung cancer and other respiratory diseases—into detectable signals. This groundbreaking process offers not only speed and accuracy but also accessibility for a wider range of patients and clinical settings.
The OneBreath™ Process
Our test is simple. Just give one full breath into a bag.
Our device then concentrates and stabilizes your breath and the VOCs within it, onto our microreactor.
That chip gets sent to a lab, where it’s then analyzed by an LCMS system.
No radiation. No needles. No Waste.
Breath Collection
Patients provide a single, complete breath through our unique collection system in less than 30 seconds. This simple act forms the basis of our non-invasive testing procedure.
Microreactor Technology
Once collected, the breath is immediately transferred to our patented microreactor. Here, a specialized chemical formulation interacts with the exhaled VOCs, transforming these elusive compounds into stable, quantifiable markers. This derivatization process is the heart of our innovation—capturing even trace levels of biomarkers with unprecedented sensitivity.
Analysis & Processing
The chemically processed sample is then analyzed using ultra-high-performance liquid chromatography coupled with mass spectrometry (UHPLC-MS). With run times typically between 1 to 10 minutes, this state-of-the-art platform quantifies the biomarkers, enabling us to detect lung cancer at its earliest stages.
Results Delivery
Just like a blood test,, results can be provided to physicians and patients, in a timely and reliable manner that empower proactive intervention.
Proven in the Clinic
OneBreath™ has been rigorously studied through multiple clinical trials involving over 800 patients for lung cancer, and has demonstrated the ability to diagnose and stratify idiopathic pulmonary fibrosis (IPF) severity using breath carbonyl metabolites, achieving AUROC values of ~0.87–0.90.
94% Sensitivity
Reliably detects early-stage lung cancer to enable prompt intervention.
85% Specificity
Minimizes false positives and reduces unnecessary follow-up procedures.
800+ Patients
Extensive clinical trials validate our technology’s impact across diverse populations.”
Multiple Global Patents
Protected innovations that secure our leadership in diagnostic advancements.”
Transforming Lung Cancer Screening
Experience a Paradigm Shift in Diagnostics with OneBreath™—where chemical innovation meets clinical precision to detect lung cancer and other respiratory diseases, early, safely, and cost-effectively.
Diagnosis with a Single Breath with Multiple Disease Potential
OneBreath quantitatively analyzes organic compounds to detect lung cancer using a single breath. But early research suggests it may be able to detect other diseases.
The Future of Diagnosing Lung Cancer
Imagine a future where a simple breath could help save lives. In this inspiring episode of Healthcare Tomorrow, Dr. Victor van Berkel and Aaron Roebuck share how new innovations in lung cancer detection are turning possibility into reality. With personal stories, groundbreaking science, and a vision for a healthier tomorrow, this conversation is filled with hope for what’s ahead.
The OneBreath Patient Process
In contrast to a Low-Dose CT Scan, OneBreath is a quicker and easier way of lung cancer diagnosis. Watch how simple our process is compared to the current standard of care, Low-Dose CT Scan.
Can We Predict Pneumonia in the Hospital?
How our groundbreaking platform is uncovering new possibilities beyond cancer detection. With early research already pointing to surprising applications, the conversation highlights how innovation and persistence are paving the way for better outcomes and healthier futures. It’s a hopeful look at how one discovery can open doors to many more.
Lung Cancer Diagnosis: Detecting Lung Cancer with a Single Breath
Lung cancer is difficult to diagnose because, for most people, there aren't any symptoms, especially at early stages. Breath Diagnostics is developing a new test detect lung cancer, using a non-invasive and simple procedure.
Innovating Beyond Conventional Diagnostics
Why OneBreath™ Stands Apart
We are not building a breathsensor. We are building a molecular UHPLC–MS/MS assay platform — breath is simply the matrix.
Orthogonal Qualifiers
5 categories of orthogonal confirmation layers position this platform at the highest level of analytical rigor.
Orders of Magnitude Linearity
The OneBreath platform delivers >10⁶ dynamic range with pptv-level sensitivity, enabling precise LC–MS quantification of breath metabolites across wide concentration ranges. With R² > 0.99, the system provides the analytical rigor required for clinical diagnostics and pharmacodynamic monitoring.
Cost-Effective & Accessible
Our streamlined process and portable design make advanced screening accessible to clinics, pharmacies, and community health centers, significantly lowering the cost per test compared to CT scans or PET imaging.
Rapid & Reproducible
The robust design of our microreactor and the efficiency of UHPLC-MS analysis ensure consistent, repeatable results—vital for clinical confidence and scalable diagnostics.
Advancing Diagnostics for a Healthier Tomorrow
FDA Breakthrough Device Designation
OneBreath™ has received FDA Breakthrough Device Designation for its ability to identify patients at elevated risk of post-operative pneumonia before symptoms appear, using molecular analysis of metabolites captured from a single exhaled breath.
By transforming breath into a quantitative LC–MS clinical assay, the platform enables noninvasive risk stratification and supports earlier, more informed clinical decisions in high-risk surgical patients.
Ready to Transform Lung Cancer Screening? Discover the Future Today.
Watch our video to learn how OneBreath™ is revolutionizing diagnostics with life-saving precision and simplicity.
