Dive Brief:
- The Food and Drug Administration’s device center has partnered with the Bill and Melinda Gates Foundation to support diagnostic development, the regulator said Wednesday.
- Using a $1.9 million Gates Foundation grant, the collaborators will create new analytical methods to help the development of breath-based diagnostic devices for detecting diseases in underserved populations.
- The goal is to help developers create more affordable tests that are suitable for use in rural and remote areas where it is challenging to use expensive, complex analytical instruments.
Dive Insight:
The FDA’s Center for Devices and Radiological Health and Gates Foundation have identified a shared interest in improving disease detection in medically underserved populations in the U.S. and overseas.
That shared interest led the organizations to team up to create new analytical methods for identifying multiple chemicals or biomarkers in complex chemical mixtures. CDRH Director Jeff Shuren said in a statement that “the methods could increase the potential for chemical characterization to identify multiple chemicals when used in premarket device testing.”
The collaborators plan to develop and validate a database of breath from healthy individuals and people infected with the bacterium that causes tuberculosis. Shuren said test developers could use the database to identify diagnostic biomarkers for TB.
Establishing 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 said.
Other goals include the creation of a database of chemical information, criteria for classifying confidence of a chemical identification and a web application analyzing mass spectrometry data. Shuren said the methods could increase confidence in measurement techniques and reduce risks for test developers and regulators.
Improving TB detection is a long-standing goal of the Gates Foundation. The nonprofit provided $7.7 million to fund 10 grants focused on finding TB diagnostic biomarkers in low-resource settings in 2012.
The focus reflects the limitations of existing lab-based TB technology. More than 4 million cases of TB go undiagnosed or unreported, according to the World Health Organization. Some cases are undiagnosed because people live in areas without the “high-quality laboratory system that uses modern diagnostics” that the WHO says is a prerequisite for accurate detection of TB.
