The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) has forged a partnership with the Bill and Melinda Gates Foundation to expedite the development of breath-based diagnostic devices.
Under the partnership, the CDRH and the Gates Foundation will create new analytical methods to help develop these devices for underserved populations.
The American private foundation will provide a $1.9m grant to assist with the project. Both partners will also collaborate with the National Institute of Standards and Technology (NIST).
According to the FDA, the initiative will develop a pathway to identify and treat diseases in rural and medically underserved areas.
Specifically, the analytical methods will be designed to detect various chemicals or biomarkers within intricate chemical combinations. As a result, the methods could enhance the capability of chemical characterisation in premarket device testing to identify multiple substances.
The new methods will help developers create a more efficient and affordable diagnostic options as high costs and the complexity of the instruments limit disease detection in remote and impoverished areas, said the FDA. These will also bolster disease detection across underserved populations, both within the US and around the world.
The FDA said that the project will involve the development, curation, and validation of an interactive web database to ensure the reliability of measurement techniques.
The database will contain breath samples from both healthy individuals and those infected with Mycobacterium tuberculosis (TB). It will enable innovators and researchers to identify crucial diagnostic biomarkers for TB patients using spectral criteria and a scoring system based on analytical chemistry methods.
Additionally, the partnership will give the diagnostics community the ability to confidently identify disease biomarkers by thoroughly characterising and establishing a baseline breath-print.
It will facilitate the development of next-generation diagnostic devices that can be used by clinicians and consumers in point-of-care settings and homes.
The methods will feature a database of chemical information, criteria to assess the confidence of chemical identifications, and a web application for the analysis of mass spectrometry data.
These will enhance confidence in measurement techniques, thereby mitigating risks for both medical device innovators and regulators, the health regulator added.
