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FDA, Gates Foundation Partner to Help Develop Breath-Based Dx for Underserved Populations

NEW YORK – The US Food and Drug Administration's Center for Devices and Radiological Health announced Wednesday that it is partnering with the Bill and Melinda Gates Foundation to create new analytical methods to help with the development of breath-based diagnostic tests for underserved populations.

The methods are intended to identify multiple chemicals or biomarkers in complex chemical mixtures, increasing the potential for chemical characterization to identify multiple chemicals when used in premarket device testing, the FDA said in a statement. The project will include the development, curation, and validation of an interactive web-based database of both healthy breath and breath infected with Mycobacterium tuberculosis bacteria. Utilizing spectral criteria and a scoring system based on analytical chemistry methods, the database can be used by test developers and researchers to help identify important diagnostic biomarkers for tuberculosis patients, the FDA noted.

The Gates Foundation provided a $1.9 million grant to assist with the project. The National Institute of Standards and Technology will also collaborate on the project.

The new methods will help developers create a more efficient and affordable option for breath-based disease detection that can be easily deployed for people living in rural and remote areas, the FDA added. Tools and methods will include a database of chemical information, criteria for classifying confidence of a chemical identification, and a web application for analysis of mass spectrometry data.