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
2024年9月30日 - 5:28PM
ビジネスワイヤ(英語)
- 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
- Project will also help extend the development of Owlstone’s
Breath Biopsy VOC Atlas database, a critical resource supporting
biomarker research
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:
-
https://www.owlstonemedical.com/science-technology/breath-biopsy-voc-atlas/
-
https://www.owlstonemedical.com/about/news/2024/apr/25/owlstonemedical-gatesfoundation/
-
https://www.owlstonemedical.com/about/news/2023/may/17/OML-wins-DIU-contract/
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240930603871/en/
Dr Ben Rutter, Zyme Communications
ben.rutter@zymecommications.com +44 (0) 7920-770935