CDRH, Bill and Melinda Gates Foundation Team Up on Diagnostics Development

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is partnering with the Bill and Melinda Gates Foundation to create new analytical methods for developing 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,” CDRH Director Jeff Shuren, M.D., J.D., and CDRH Office of Science and Engineering Laboratories Director Ed Margerrison, Ph.D., said in a joint statement. “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 measurement techniques, the project—funded with a $1.9 million grant from the Bill and Melinda Gates Foundation—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,” Shuren and Margerrison stated. 
 
The 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. These methods are intended to help drive confidence in measurement techniques and ultimately reduce risk for both medical device innovators and regulators. Advancing chemical characterization and providing developers with methods to detect diseases in rural and medically underserved populations will provide enormous benefits to the public health, domestically and internationally, according to CDRH executives.  

The ultimate goal of this collaboration is the development of a pathway for identifying and treating diseases in rural and medically underserved areas. The FDA will work toward this goal in collaboration with the National Institute of Standards and Technology (NIST), which is also partnering with the Bill and Melinda Gates Foundation.  

“Guided by our shared interest in advancing health equity and equality, this partnership can ultimately open the possibility of widespread disease detection in medically underserved populations both domestically and globally,” Shuren and Margerrison concluded. “We are proud to partner with the Bill and Melinda Gates Foundation on this project to advance health equity—one of the Center’s Strategic Priorities—and protect and promote the public health in the U.S. and globally.”