FDA and Bill & Melinda Gates Foundation Partner to Develop Breath-Based Disease Diagnostic Devices

The FDA’s Center for Devices and Radiological Health (CDRH) has announced 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.”

The methods are specifically 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.” They are also meant to provide a “more efficient and affordable option that could be more easily deployed across populations living in rural and remote areas.”

An interactive web database of “both healthy breath and breath infected with Mycobacterium tuberculosis bacteria (TB)” will need to be developed, curated, and validated in order to assist in identifying “important diagnostic biomarkers for TB patients.” In addition, the methods will include “criteria for classifying confidence of a chemical identification and a web application for analysis of mass spectrometry data.”

The Bill and Melinda Gates Foundation is providing a $1.9 million grant to the FDA to work toward this goal in collaboration with the National Institute of Standards and Technology (NIST).