OneBreath™ by Breath Diagnostics: The Simply Superior Breath Analysis Solution

Breath analysis has long held the promise of revolutionizing diagnostics, particularly in detecting diseases like lung cancer through non-invasive means. However, despite decades of research, traditional breath analysis has struggled to gain widespread clinical adoption. The core issue? A lack of standardization in sampling, pre-concentration, and analysis methods.

Enter OneBreath™ by Breath Diagnostics (BDx)—a game-changing technology that overcomes the pitfalls of traditional breath analysis while providing unparalleled accuracy, reliability, and ease of use. Let’s explore why OneBreath™ is simply superior to other breath analysis methods.

The Challenges of Traditional Breath Analysis

Before we dive into OneBreath™’s innovation, let’s look at the shortcomings of traditional breath analysis:

1. Lack of Standardization in Sampling

Breath composition varies significantly based on how it is collected. Traditional methods distinguish between:

• End-tidal breath (deep lung air)
• Late expiratory breath (includes upper airways)
• Mixed expiratory breath (a blend of lung and oral cavity air)

These variations introduce inconsistencies in biomarker concentration measurements, making it difficult to establish reliable diagnostic thresholds.

2. Pre-Concentration Problems

Breath biomarkers exist in extremely low concentrations, requiring pre-concentration techniques before analysis. Traditional methods rely on sorbent tubes, such as:

• Thermal desorption tubes
• Solid-phase microextraction (SPME)
• Needle trap devices (NTDs)

These methods introduce contamination risks and sample degradation, leading to inconsistent and unreliable results.

3. Inefficiencies in Ionization and Analysis

Gas chromatography-mass spectrometry (GC-MS) remains the gold standard for breath biomarker validation, but it has limitations:

• Thermal degradation risk due to heating during desorption
• Loss of VOCs during transfer
• Inconsistent ionization efficiency
• Extremely slow analysis times—GC-MS takes up to an hour per sample

These drawbacks have hindered traditional breath analysis from becoming a routine diagnostic tool.

How OneBreath™ is Simply Superior

OneBreath™ completely redefines breath analysis by addressing these long-standing challenges. With a patented microreactor technology, it enables a more efficient, standardized, and accurate diagnostic process.

1. Standardization Through One Exhale

OneBreath™ streamlines sampling by requiring just one exhale into a Tedlar® bag. This single-breath approach ensures that every sample contains a standardized concentration of volatile organic compounds (VOCs), solving a major issue in breath diagnostics.

Eliminates variability in sampling

• Ensures precise biomarker concentration measurements
• Enhances reproducibility and clinical reliability

With OneBreath™, we no longer need to worry about sampling inconsistencies—it’s a single, controlled breath every time.

2. Smart VOC Capturing with a Novel Microreactor

Instead of relying on traditional adsorption-based trapping, where VOCs are physically stuck onto surfaces and later released by heating (which can cause sample degradation), OneBreath™ chemically derivatizes VOCs into adducts.

Why is this better? The microreactor forms stable cationic adducts, which are chemically bound rather than physically trapped. This:

• Prevents sample loss
• Reduces contamination risks
• Improves measurement sensitivity

3. Breakthrough Ionization for Ultra-Sensitive Analysis

Unlike GC-MS, which requires thermal desorption, OneBreath™’s microreactor method enhances ionization efficiency, making analysis both easier and more reliable.

Traditional VOC trapping (Desorption Tubes):

• VOCs are physically adsorbed and require heating to be released
• Heating can cause fragmentation and loss of biomarkers
• Requires additional sample preparation steps

OneBreath™ Technology (BDx Derivatization):

• VOCs form stable cationic adducts instead of being adsorbed
• These adducts are already ionized, making mass spectrometry analysis far more sensitive and accurate
• Cold solvent rinsing (not heat) releases VOCs, eliminating concerns over thermal degradation

4. The Ultimate Analytical Advantage: No Thermal Desorption Required

OneBreath™ uses UHPLC-MS (Ultra-High-Performance Liquid Chromatography-Mass Spectrometry) for biomarker detection, offering significant advantages:

• No thermal degradation – samples remain intact
• No additional sample preparation needed – no complex desorption steps
• All adducts are positively charged – ensures consistent and efficient ionization

5. Commercial Throughput: OneBreath™ is 10x Faster

One of the biggest challenges in traditional breath analysis is processing time. Traditional methods are slow and inefficient, making high-volume testing commercially unfeasible.

Traditional Analysis: Slow and Inefficient

• GC-MS analysis can take upwards of 1 hour per sample
• Patient sampling with desorption tubes takes 15–30 minutes
• Throughput is low, making large-scale implementation impractical

OneBreath™: Built for Speed and Scalability

• UHPLC-MS analysis takes less than 10 minutes per sample
• Patient sampling takes only 30 seconds
• Enables high-throughput diagnostics, making breath analysis commercially viable

What does this mean? OneBreath™ is significantly faster and more feasible for real-world applications, making it the first truly scalable breath analysis technology.

The Future of Breath Analysis is Here

With OneBreath™, Breath Diagnostics has transformed a major industry challenge into its biggest strength. By tackling standardization, sample integrity, and ionization efficiency, OneBreath™ makes breath analysis:

• ‍More reliable – Controlled, standardized sampling eliminates errors‍
• More accurate – Derivatization ensures ultra-sensitive biomarker detection‍
• More efficient – No need for complex sample preparation or thermal desorption‍
• 10x Faster – Ultra-fast sampling and analysis enable real-world implementation

Traditional breath analysis has struggled with consistency and practicality—but with OneBreath™, the future of breath diagnostics is now a reality.

Ready to see the future of non-invasive diagnostics? Stay tuned as Breath Diagnostics continues to revolutionize breath analysis technology.