Vendor Product Release

Non-invasive Early Disease Detection and Precision Medicine Using Breath Biomarkers

11 January 2022
Breath is the ideal biomarker matrix for the future of diagnostics. Sample collection is non-invasive, painless and easy to perform, and breath is a rich source of potential biomarkers. Potential applications for breath tests include disease detection, phenotyping, progression and treatment monitoring, and complementary diagnostics. Discover the benefits and capabilities of breath testing, and start researching breath biomarkers with Breath Biopsy®.

Tests based on blood, urine and faeces have become common place in healthcare, yet the potential of breath remains largely overlooked. Among its many benefits, breath collection is painless and completely non-invasive making it an extremely versatile sampling matrix. Owlstone Medical has become a leader in the field of breath biomarker research with Breath Biopsy® and aims to develop clinically-relevant biomarker tests.

Breath is a Rich Biomarker Matrix

Exhaled breath contains over 1,000 volatile organic compounds (VOCs). Those are products of intrinsic biological and metabolic pathways and can be linked to factors such as inflammation, oxidative stress, enzymatic and bacterial activity, and environmental exposures. Therefore, exhaled VOCs hold the potential to perform as diagnostic and companion biomarkers for applications including disease detection and precision medicine.

Overview of Biomarkers on Breath – Breath contains many prospective biomarkers for disease in the form of volatile organic compounds (VOCs). VOCs can originate within the body or from external sources

Breath sampling has several key strengths. It is non-invasive, pain-free, safe and easy to use both for point of care and home testing applications. As a result, patients generally view breath tests as preferable to other sample types. Compounds detected on breath are carried to the lungs via the blood, so breath tests reflect changes throughout the body, and breath is an unlimited resource making it ideal for collecting large samples, repeated sampling and ongoing monitoring. More details on breath biomarkers are available in Breath Biopsy: The Complete Guide.

Applications of Breath Analysis

Many applications for breath biomarkers are being explored. Following the limited success of liquid biopsies, breath biopsies have been proposed as an emerging option for screening and early disease detection. This is most notable in cancer, where breath tests could detect metabolic changes that precede the release of tumor DNA into the blood. Breath tests have also been considered for early detection in liver diseases, which are often asymptomatic in their early stages, cardiometabolic diseases such as diabetes and chronic kidney disease, and neurodegenerative disorders.

Breath tests for precision medicine have largely been explored in areas where disease phenotypes share symptom profiles, this includes respiratory diseases like asthma, COPD and IPF, and gastrointestinal diseases particularly IBS and food intolerances.

There is growing interest too in drug development, where breath biomarkers can be linked to metabolic processes associated with drug targets and pharmacokinetics. In clinical trials, breath biomarkers could help patient stratification, monitor responses and adverse events, and provide surrogate endpoints.

While there is evidence to support these applications, few validated breath biomarkers have yet emerged in clinical use.

Breath Collection Needs to be Sensitive and Reliable

Variation, humidity and background signals can all be issues for breath collection. Simple collection devices have included bags and tubes that collect non-standardized volumes, are easily contaminated and result in samples that can be difficult to handle, store and process.

Breath Biopsy uses the ReCIVA® Breath Sampler. ReCIVA was designed in consultation with over 100 leading researchers through the BreatheFree consortium. ReCIVA channels exhaled breath through four sorbent tubes that capture VOCs. Since ReCIVA extracts VOCs during sample collection, samples are much more compact and durable. As a result, Breath Biopsy collects VOCs from a larger volume of breath, which boosts sensitivity for low-abundance compounds. Using four separate tubes allows simultaneous collection of duplicate samples for parallel analysis or as back-up samples.

Industry Insight from Owlstone Medical
ReCIVA Breath Sampler – A breath collection device developed with leading researchers to provide reliable, consistent VOC collection from human breath

During sampling, ReCIVA monitors and learns a patients’ breathing patterns and is able to selectively capture the most relevant breath fractions. ReCIVA also ensures consistent sample volume and provides detailed metadata that helps to assess sample quality during analysis.

ReCIVA works together with the CASPER® Portable Air Supply to exclude VOC contamination from ambient air, and provide a consistent, versatile and reliable approach for breath sample collection that is being used in some of the worlds’ largest breath-based clinical trials and in over 100 clinical and research sites worldwide.

OMNI – The Complete Solution for Global Breath Biomarker Analysis

One of the key factors limiting the widespread adoption of breath as a diagnostic modality is a lack of validated breath biomarkers. To date, breath research studies have used a diverse range of analysis techniques and this variation has limited comparability between studies and prevented effective biomarker validation. Making progress in the field requires consistency, particularly in how we identify biomarkers and report their associations with particular phenotypes.

Our Breath Biopsy OMNI service harnesses Owlstone Medical’s 15 years of expertise in high-sensitivity compound detection to provide accurate, robust and reproducible global breath biomarker analysis. OMNI uses high resolution accurate mass gas chromatography mass spectrometry (HRAM GC-MS; see our whitepaper) to prioritize compound detection and to maximize signal to noise ratio. It is a complete package incorporating our expertise in breath study planning and design, our cutting-edge breath collection products, world-leading sample processing and analysis as well as in-depth data analysis and biological interpretation capabilities.

Industry Insight from Owlstone Medical
Breath Biopsy OMNI – A complete end-to-end service for global VOC biomarker analysis on breath. In addition to sample collection and processing, OMNI includes support for study planning and design as well as expert statistical analysis and interpretation.

OMNI is unique in being optimized to detect on-breath compounds. Many studies include all compounds detected from breath without consideration of their origins or biological relevance. On-breath compounds occur at significantly higher levels in breath samples than in the ambient air. This means that OMNI focuses on compounds affected by a patient’s biology, making our biomarker detection capability more sensitive, robust and less prone to false positives.

Our recent projects include a study looking at lung damage caused by long-term strenuous exercise, and investigations of limonene as potential biomarkers of liver diseases. Find out more about OMNI and our work in liver diseases in our on-demand webinars.

Getting Started with Breath Biopsy

Breath is a diverse biomarker matrix with great potential to dramatically improve the detection and treatment of a wide range of diseases. Breath sampling is non-invasive, easy and well-tolerated making it suitable for public screening programs, drug development, patient stratification, ongoing monitoring, and detection of exacerbations or relapses.

Our team will be participating in the Biomarkers US conference in February 2022, contact us to talk about adding Breath Biopsy to your studies and to find out how OMNI can help you to uncover non-invasive disease biomarkers.

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