Breath Biopsy Tests
Developing Breath Biopsy for clinical applications in early detection and precision medicine
Through Breath Biopsy Tests, we aim to realize our mission of saving 100,000 lives and $1.5B in healthcare costs by applying our expertise in breath biomarker discovery and analysis to the areas of greatest clinical need. We constantly assess the latest developments in research and healthcare to identify opportunities for Breath Biopsy to make a difference to early detection of disease or the implementation of precision medicine. Our primary areas of focus are in cancer, liver disease, and respiratory disease, however the potential range of applications of Breath Biopsy is very broad and we are exploring many other uses both internally and through our partnerships.
To develop high-impact breath solutions, we deploy a two-stage development pipeline. Initially, we combine internal expertise, published scientific knowledge and our own research results to develop Research Use Only (RUO) Panels, based primarily on the content of our evolving Breath Biopsy OMNI Assay. Once on market, we further develop and refine these RUO Panels until we are ready to seek in vitro diagnostic device (IVD) status when appropriate.
Explore the Applications of Breath Biopsy for Early Detection, Precision Medicine and ExposureFind out more
One in two people will get cancer in their lifetimes. Globally, lung cancer is the most common cancer in the world with 2.1 million new cases identified in 2018. ln the early stages, the chance of surviving cancer is ten times higher and the cost of treatment ten times lower than in the later stages, and so detecting cancer early is by far the best way to improve cancer survival.
The Breath Biopsy Lung Cancer Screening Test in development involves a combination of VOCs associated with lung cancer from an early stage, and an EVOC Probe administered from outside the body to target specific cancer pathways. Both sets of biomarkers can be detected non-invasively though Breath Biopsy and work is underway to integrate them into a single cancer detection analysis. Our work suggests that almost 90% of Stage I lung cancers can be targeted, with the potential to have a transformative effect on cancer detection.
In developed countries, driven by poor diet and low exercise, fatty liver diseases have quietly reached epidemic levels across both adults and children. In the early stages, symptoms of liver disease are few, which is why the scale of the problem has gone largely unnoticed. With care the liver can heal itself, but without timely action liver damage can become permanent.
The economic impact of liver disease is enormous. For example, in the United States approximately 30% of US adults and as many as 1 in 10 children suffer from some form of liver disease, leading to direct and societal costs estimated at almost $300B per year. There is therefore an acute need for earlier detection when lifestyle changes and therapeutics can be effectively deployed, and the number of patients experiencing severe symptoms reduced.
The liver is highly metabolically active making it a prime source of VOCs on breath. The current gold standard for diagnosis requires a liver biopsy, and so a non-invasive breath test represents a preferable and potentially more reliable approach for disease detection. Our approach centers on the development of exogenous VOC probes (EVOC® Probes), such as limonene, that provide a way to measure the activity of specific biological processes linked to liver function. EVOC Probes are safe compounds that can be administered to patients and measured on breath.
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Chronic respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD) affect over 500M people worldwide and the annual cost of treatment in the US alone is almost $60B. Although these diseases are common, diagnosis is complex as the symptoms between them overlap considerably. Further, each of these diseases can be driven by multiple subtypes with very different underlying biology and as a result choosing the right treatment is difficult.
At present, treatment relies on trial and error, where each error costs healthcare systems huge amounts of money and has a serious impact on a patient’s quality of life. A non-invasive breath test that is easy to administer and suitable for a wide range of patients would enable the right treatment to be offered sooner, and would have a profound impact on both associated costs and quality of care.
Volatile organic compounds (VOCs) on breath have repeatedly shown promise in differentiating respiratory disease subtypes. Some of these VOCs originate directly from the underlying inflammatory responses that cause these diseases, making them especially reliable indicators.
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Over one billion people worldwide are affected by gastrointestinal illness, and in the US alone this results in $21 billion of direct and indirect costs each year. While symptoms can be mild, they can also be severe and debilitating with significant impacts on quality of life. Key conditions include small intestinal bacterial overgrowth (SIBO), food intolerances such as carbohydrate malabsorption, inflammatory bowel disease (IBD), gastroesophageal reflux (GORD) and irritable bowel syndrome (IBS).
Despite the range of illnesses that can affect gastrointestinal health, symptoms are largely similar and non-descript including bloating, flatulence, diarrhea and constipation. Achieving a diagnosis can also be a drawn out and embarrassing experience for patients, often taking several years. In partnership with Functional Gut Diagnostics, we are providing Breath Tests that aid in the diagnosis of SIBO, lactose intolerance and fructose intolerance. We are also investigating applications for VOC biomarkers, which have shown to have promise in detecting IBD and other gastrointestinal diseases.
Our vision is to develop a menu of Breath Biopsy Digestive Health Tests and other tools to help patients to manage their day to day symptoms, understand the impact of diet on their digestive health, and help to detect and diagnose a wide range of gastrointestinal health issues.
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