Summary: The FDA’s CDRH, in partnership with the Bill and Melinda Gates Foundation, is developing new analytical methods for breath-based diagnostic devices to enhance disease detection in underserved populations.


  1. Innovative Diagnostic Development: The initiative focuses on creating efficient, cost-effective breath-based diagnostics that can detect multiple biomarkers, aiming to simplify and improve disease detection in remote and impoverished areas.
  2. Targeted Disease Identification: A major component of this project is the creation of an interactive web database for identifying tuberculosis biomarkers in breath samples, using robust analytical chemistry methods to advance TB diagnosis.
  3. Support and Collaboration: Supported by a $1.9 million grant from the Gates Foundation, the FDA and NIST are collaborating on this project to establish reliable diagnostic methods that could transform disease management in rural and underserved regions globally.

The FDA’s Center for Devices and Radiological Health (CDRH) is partnering 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. 

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, according to the administration.    

Improving Disease Detection for the Underserved

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. 

Addressing Tuberculosis

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.

Breath-Based Diagnostics

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.

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.  

With the support of a $1.9 million grant from the Bill and Melinda Gates Foundation, the goal of this collaboration will ultimately be the development of a pathway for identification and an opportunity for treatment of disease 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, the administration says.