The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) and Ed Margerrison, Ph.D., director of the Office of Science and Engineering Laboratories (OSEL), CDRH
Today, the FDA’s Center for Devices and Radiological Health (CDRH) is announcing a partnership with the Bill and Melinda Gates Foundation to create new analytical methods to help the development of breath-based diagnostic devices for disease detection in underserved populations. In particular, these methods are intended to identify multiple chemicals or biomarkers in complex chemical mixtures, and thereby increase the potential for chemical characterization to identify multiple chemicals when used in premarket device testing.
Due to high costs and the complexity of the instruments needed to perform an analysis, disease detection in remote and impoverished areas can be extremely challenging. These new methods are intended to help developers create a more efficient and affordable option that could be more easily deployed across populations living in rural and remote areas.
To ensure confidence in our measurement techniques, this project will include developing, curating, and validating an interactive web database of both healthy breath and breath infected with Mycobacterium tuberculosis bacteria (TB). Using spectral criteria and a scoring system based on robust analytical chemistry methods, the web database can then be used by innovators and researchers to assist in identifying important diagnostic biomarkers for TB patients.
This full characterization and establishment of a basal-level breath-print will give the diagnostics community the ability to confidently identify disease biomarkers and facilitate the development of next-generation diagnostic devices that can be used by clinicians and consumers at the point of care and in the home.
CDRH Announces Partnership with the Bill and Melinda Gates Foundation
The goal is to help with the development of breath-based diagnostics for disease detection in underserved populations.
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