Non-Invasive Testing: Transforming the Patient Experience with Breath Diagnostics

Breath analysis has captured the imagination of clinicians and researchers for decades. The idea that a simple exhalation might reveal the earliest signs of diseases—from infections to cancer—has fueled hundreds of studies linking volatile organic compounds (VOCs) in our breath to various health conditions. Yet, despite this strong body of evidence, commercializing breath tests has been difficult. Traditional methods often require thermal desorption, multiple breaths, and lengthy analysis times—sometimes over an hour—with Gas Chromatography–Mass Spectrometry (GC-MS). This cumbersome process makes it harder to implement breath tests in real-world clinical settings.

At Breath Diagnostics Inc., we have developed a system that addresses these limitations through a patented chemical microreactor and Liquid Chromatography–Mass Spectrometry (LC-MS). By reducing sample preparation steps, eliminating complex ionization processes, and doing away with the need for heat altogether, we can deliver ultra-sensitive results in under 10 minutes, promising a new era of rapid, reliable, and commercially scalable breath diagnostics.

We call this technology OneBreath™ - because it only takes one breath.

A Brief History of Breath Analysis

The concept of diagnosing disease by analyzing breath dates back centuries. Ancient physicians used the scent of a patient’s breath to detect conditions like diabetes, and modern studies have revealed that certain VOC profiles can signify illnesses such as lung cancer and chronic obstructive pulmonary disease (COPD). According to a 2017 review published in the Journal of Thoracic Disease, breath analysis has “immense potential” for early cancer detection.

Despite extensive research—spanning hundreds of published articles—practical adoption has lagged because traditional breath analysis methods are slow, equipment-intensive, and prone to VOC degradation. Thermal desorption is particularly challenging: it captures VOCs on specialized tubes and releases them through heating, which can take more than an hour and often degrades temperature-sensitive molecules.

Why Faster, More Accurate Diagnostics Matter

Early detection can dramatically improve patient outcomes for many diseases, including lung cancer—the world’s leading cause of cancer-related deaths. While low-dose computed tomography (LD-CT) and PET scans can identify early-stage tumors, these methods can be expensive, are not always accessible, and may yield false positives. A rapid, non-invasive breath test—if reliable—could help bridge these gaps by identifying at-risk individuals earlier and more efficiently.

Beyond oncology, breath analysis may also help in managing conditions such as asthma, tracking metabolic disorders, and detecting infectious diseases. As healthcare systems pivot toward preventive care, widely accessible diagnostic tools are increasingly critical. A quicker, simpler breath test could serve as a first-line screening method, flagging health concerns early and guiding further, more detailed investigations when necessary.

Overcoming the Thermal Desorption Roadblock

One of the biggest obstacles in breath diagnostics is thermal desorption, which captures VOCs in tubes and then releases them via heating. The process is not only lengthy—sometimes taking more than an hour—but also requires bulky, specialized equipment and highly trained technicians. Moreover, high temperatures can degrade delicate VOCs, making test results less reliable.

These factors drive up costs, slow patient throughput, and limit the contexts in which breath tests can be effectively used. To become a practical, widespread diagnostic option, breath analysis must be fast, accurate, and simple to implement.

Revolutionizing Breath Analysis

At Breath Diagnostics, we are transforming the field with our patented microreactor technology and OneBreath™ system. Instead of relying on multiple exhalations, thermal desorption, and GC-MS, OneBreath™ requires just one exhale. The VOCs are then “trapped” in the microreactor and measured using Liquid Chromatography–Mass Spectrometry (LC-MS).

Key Advantages of LC-MS with OneBreath™

1. Under 10 Minutes: While GC-MS can take an hour or more, OneBreath™ delivers accurate results in under 10 minutes, significantly speeding up diagnostics.

2. No Heat Required: In contrast to thermal desorption, which can degrade sensitive VOCs, OneBreath™ releases and processes samples via a simple cold solvent rinse. By eliminating the need for high temperatures, it preserves VOC integrity and ensures more reliable results.

3. Reduced Ionization Complexity: Traditional GC-MS often requires intricate ionization steps. OneBreath™ simplifies ionization by leveraging a patented chemical microreactor that eliminates many of the complexities common with other mass spectrometry methods.

4. Scalable and Cost-Effective: Shorter run times and minimal sample preparation pave the way for broader clinical adoption, from large hospitals to smaller clinics—and potentially even pharmacies.

With just a 30-second patient sampling window, the OneBreath™ approach is also far more user-friendly. Patients provide a single exhalation, drastically improving compliance and streamlining workflows. This simplicity and speed can support large-scale screening programs and open the door to faster discoveries of new breath-based biomarkers.

Potential to Transform Healthcare

A quick, accurate breath test could have a massive ripple effect in healthcare. For lung cancer—which accounts for nearly 20% of all cancer deaths worldwide—improved early detection can save countless lives. Accessible screening with OneBreath™ could reduce imaging bottlenecks, identify cases earlier, and ultimately enhance survival rates.

Moreover, this technology can expand to other disease areas, from monitoring organ transplant rejection to tracking metabolic conditions. Faster analysis times and higher throughput mean researchers can rapidly study novel VOC profiles, potentially identifying early markers for various illnesses.

Looking Ahead

Breath analysis stands at the threshold of becoming a practical, frontline diagnostic tool. Backed by hundreds of studies confirming the power of VOC-based disease detection—and propelled by an innovative, microreactor-based LC-MS approach that overcomes the drawbacks of thermal desorption—Breath Diagnostics Inc. and OneBreath™ are poised to change the landscape of disease detection.

In this new era, the simple act of breathing could provide critical insights into our health, enabling earlier interventions and improving patient outcomes worldwide. The promise of non-invasive, rapid, and scalable breath diagnostics is finally within reach, and its impact could reverberate through healthcare systems for decades to come.

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References and Further Reading

1. World Health Organization. Cancer.

2. Mazzone PJ, et al. (2017). A Decade of Progress in Volatile Organic Compound Breath Testing for Lung Cancer. Journal of Thoracic Disease, 9(Suppl 13): S1332-S1334.

3. Behera D, Balamugesh T. (2004). Lung cancer in India. Indian Journal of Chest Diseases and Allied Sciences, 46(4): 269-281.

Note: The information provided in this blog is based on publicly available research and data, combined with insights from the team at Breath Diagnostics Inc.

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