Owlstone Medical Enters into a Research Collaboration Agreement with the FDA to Support the Confident Identification of Volatile Organic Compounds on Breath and Expansion of its Breath Biopsy VOC Atlas®

Published on: 30 Sep 2024

  • The collaboration will develop analytical methods to improve the identification of specific chemicals in complex gaseous mixtures
  • Owlstone will use the developed methods and techniques to enhance its work in the field of breath-based biomarkers of disease
  • The project will also help extend the development of Owlstone’s Breath Biopsy VOC Atlas® database, a critical resource supporting biomarker research

 

Cambridge, UK, September 30, 2024: Owlstone Medical (“Owlstone”), the global leader in Breath Biopsy® for applications in early disease detection and precision medicine, today announced it has entered into a Research Collaboration Agreement with the FDA’s Center for Devices and Radiological Health (“CDRH”) – Office of Science and Engineering Laboratories (OSEL). The goal of the collaboration is to develop methods for the confident identification of individual chemicals in the complex mixture of breath.  Owlstone intends to use the results of this collaboration to support its efforts to identify disease biomarkers and the future development of portable breath diagnostic devices, including in its ongoing work with the Bill and Melinda Gates Foundation.

The five-year agreement will address the need in the broader breath research community for a set of validated methods to support the identification of Volatile Organic Compounds (VOCs) on breath, an area in which Owlstone is a leader. Owlstone will separately use the outcomes for the development of breath-based diagnostics, enabling in vitro diagnostic device manufacturers, biopharma, academic research centers, and government agencies to confidently identify breath biomarkers related to disease. Work will also take place to build the concept of the chemical universe on breath that researchers can use to support the efficient and robust design of analytical studies.

Regulatory Science Tools (RSTs) are the FDA’s innovative science-based approaches to assess the safety and effectiveness of medical devices and emerging technologies. This collaboration aims to develop RSTs for the identification of VOCs in complex mixtures. It is anticipated that the RSTs will help accelerate product development and disease diagnoses in rural and economically burdened areas globally. This collaboration will also aid in furthering the development and population of Owlstone’s Breath Biopsy VOC Atlas1, a unique database of identified and quantified VOCs on breath.

Owlstone recently announced a partnership with the Bill and Melinda Gates Foundation2 to develop remote-use breath-based diagnostics and identify breath biomarkers for TB and human immunodeficiency viruses (HIV) as well as advancing Owlstone’s Breath Biopsy® platform including expansion of the Breath Biopsy VOC Atlas database.

Billy Boyle, co-founder and CEO at Owlstone Medical, said: “As evidenced by the high level of activity and investment being driven through the FDA, the Bill and Melinda Gates Foundation, and other groups such as the U.S. Department of Defense3, the potential for breath-based diagnostics in high-need areas is becoming more widely realized.” He continued: “By defining rigorous practices for analysis and harnessing the collective knowledge and experience of the FDA, we aim to collaboratively create a common set of analytical methodologies that will serve as a valuable reference for the entire breath research community. We believe these RSTs have the potential to accelerate the future development of simple and low-cost non-invasive diagnostic tests and portable devices. We are proud and delighted to have been chosen as their partner in this important project.”

 

References:

  1. https://www.owlstonemedical.com/science-technology/breath-biopsy-voc-atlas/
  2. https://www.owlstonemedical.com/about/news/2024/apr/25/owlstonemedical-gatesfoundation/
  3. https://www.owlstonemedical.com/about/news/2023/may/17/OML-wins-DIU-contract/

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What is Breath Biopsy®

Breath Biopsy represents an entirely new way to determine the chemical makeup of breath by measuring volatile organic compounds (VOCs), gaseous molecules that can be sampled quickly and non-invasively. VOCs originate from all parts of the body as the end product of metabolic processes, making Breath Biopsy applicable to a wide range of diseases including lung cancer, liver disease, and digestive disease. The nature of Breath Biopsy therefore makes it perfectly suited to addressing two of the major challenges of healthcare today: early detection of disease and precision medicine.

About Owlstone Medical

Owlstone Medical’s vision is to save 100,000 lives by realizing the enormous promise of breath-based diagnostics through the development and application of Breath Biopsy®, a unique platform capable of both biomarker discovery and use in routine clinical testing.

The platform includes ReCIVA®, a proprietary sample collection device that can take stable breath samples anywhere, the world’s only commercial-scale Breath Biopsy Laboratory located in Cambridge, U.K., and the Breath Biopsy VOC Atlas®, the most extensive catalog of identified volatile organic compounds (VOCs) commonly found on breath. The Company’s technology is protected by over 160 granted and pending patents and has been used in more than 100 research papers.

Owlstone Medical’s Research Products and Services are being deployed at over 100 sites around the world with large pharmaceutical companies including AstraZeneca, Actelion (a J&J company), GlaxoSmithKline, and leading academic institutions. Projects are supported by Breath Biopsy OMNI®, the most advanced solution for reliable end-to-end global breath VOC analysis, which is helping researchers advance biomarker discovery and disease research and maximizing the chances of finding clinically relevant breath biomarkers.

The Company has a portfolio of Breath Biopsy tests in development for the early detection of lung cancer and liver disease, both areas of high unmet clinical need that represent multi-billion dollar market opportunities. In digestive health, under the OMED Health brand, clinical tests for Small Intestinal Bacterial Overgrowth and carbohydrate malabsorption are on the market in the U.K., and a handheld device and app for longitudinal monitoring of digestive health is in development.