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 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 development and population of Owlstone’s Breath Biopsy VOC Atlas^®1, 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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