The Path to Standardization

Jan 2, 2025

The Path to Standardization: How Breathomix is Pioneering Guidelines for Breath Tests

Breath analysis represents a groundbreaking approach to diagnosing diseases and guiding personalized care. Yet, without clear guidelines and standardized methods, widespread adoption remains a challenge. At Breathomix, we are committed to addressing these barriers and setting the stage for breath tests to become a routine diagnostic tool, just like blood tests.

Why Standardization is Crucial

In healthcare, consistency is key. Physicians, researchers, and regulators need to trust that diagnostic tools deliver accurate and reproducible results. This is especially important for breath analysis, a relatively new field, where variations in methods and interpretations could undermine its reliability. Without standardization:

Results may vary between devices, locations, or users.
Confidence in the technology is harder to establish among healthcare providers.
Regulatory approval (e.g., CE marking, FDA clearance) becomes more complex.

Standardization bridges these gaps, ensuring that breath tests consistently meet the highest scientific and clinical standards.

Breathomix’s Approach to Setting the Standard

At Breathomix, we envision breath analysis as an integral part of everyday healthcare. Achieving this goal requires a multi-pronged approach:

1. Conducting Prospective Validation Studies
Scientific validation is the foundation of any diagnostic tool. Together with leading academic institutions and hospitals, we are conducting 70+ large-scale clinical studies to validate the SpiroNose for various diseases.

For example:

- A recent external validation study demonstrated the SpiroNose’s accuracy in detecting lung cancer across diverse patient populations.
- Ongoing studies for Interstitial Lung Disease (ILD) and Progressive Pulmonary Fibrosis (PPF) further highlight our commitment to evidence-based innovation.

2. Leveraging Cloud Calibration Technology
One of the challenges in breath analysis was ensuring consistency across devices. Our proprietary cloud calibration method, introduced in 2019, enables us to correct minor sensor differences in real time. This allows breath profiles to be standardized and compared globally, facilitating cross-border collaboration and scalability.

3. Building Robust Reference Databases
The BreathBase platform hosts a growing database of anonymized breath profiles and associated clinical data. This database supports the development of highly accurate diagnostic algorithms, ensuring reproducibility regardless of location or patient demographics.

4. Collaborating with Medical Experts
Developing diagnostic tools that meet clinical needs requires close collaboration with physicians, researchers, and regulatory bodies. We actively work with pulmonologists and laboratory specialists to create protocols that seamlessly integrate breath testing into routine care.

From Validation to Clinical Guidelines

While validation studies provide critical scientific evidence, true adoption hinges on inclusion in clinical guidelines. Organizations like the European Respiratory Society (ERS) play a pivotal role in establishing these standards.

What could accelerate progress is better alignment between companies and research centers regarding standardization efforts, similar to how lung function testing has been standardized. Clear communication within the field, potentially led by the ERS or EU, could help prepare the ground for robust and widely accepted guidelines.

Addressing Environmental Factors

Another aspect of standardization is accounting for external influences. Breath profiles can be affected by ambient air quality, temperature, diet, or medications. Breathomix tackles these challenges by describing clear ambient requirements for breath tests and by continuously monitoring of environmental factors and optimizing our analyses to ensure accuracy.

Why Standardization Matters for Patients

For patients, standardization means: 1. Faster and more reliable diagnoses, 2. Access to non-invasive testing methods, reducing the need for biopsies or blood draws and 3. Improved outcomes through earlier detection and targeted treatments.

Setting the Gold Standard in Breath Analysis

At Breathomix, we are not just developing cutting-edge technology; we are laying the groundwork for a future where breath tests are as routine as blood tests. Achieving this vision requires collaboration across the medical community, rigorous validation, and the creation of globally accepted standards.

We believe that the potential of breath analysis is immense—what we know today is only the beginning. By prioritizing standardization, we can ensure this technology achieves its full impact in transforming healthcare.

References

Twitter

Facebook