Tuesday, July 16, 2024

Breath-Based Diagnostics Advanced by FDA and Gates Foundation Partnership

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Breath-based diagnostic development is being supported by a partnership between the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and the Bill and Melinda Gates Foundation. Funded by a $1.9 million grant from the Gates Foundation, this collaboration aims to create new analytical methods to help developers produce affordable diagnostic tests that can be easily deployed in rural and remote areas, where the use of expensive and complex analytical instruments is often challenging.

The primary goal of this collaboration is to enhance disease detection in medically underserved populations both in the United States and internationally. By focusing on the development of breath-based diagnostics, the initiative seeks to improve access to affordable and effective disease detection methods. The FDA and Gates Foundation will work together to create and validate a database of breath samples from healthy individuals and those infected with tuberculosis (TB). This database will help developers identify diagnostic biomarkers for TB and potentially other diseases.

The partnership will focus on developing new analytical methods for identifying multiple chemicals or biomarkers in complex chemical mixtures. These methods will be used in premarket device testing to increase the potential for chemical characterization. According to CDRH Director Jeff Shuren, the goal is to provide the diagnostics community with the tools needed to confidently identify disease biomarkers, facilitating the development of next-generation diagnostic devices that can be used at the point of care and in the home.

Breath-Based Diagnostics Initiative Targets Improved TB Detection and Reliable Biomarker Identification

The initiative involves establishing a comprehensive database of breath samples from healthy individuals and TB-infected patients to serve as a reference for identifying diagnostic biomarkers, creating a database of chemical information and criteria for classifying the confidence of chemical identifications to ensure accurate and reliable measurements for test developers and developing a web application to analyze mass spectrometry data to increase confidence in measurement techniques and reduce risks for test developers and regulators.

Improving TB detection is a significant focus of this initiative. The Gates Foundation has a long-standing goal of enhancing TB diagnostics, having previously provided $7.7 million to fund 10 grants aimed at finding TB diagnostic biomarkers in low-resource settings in 2012. Despite these efforts, TB remains a major global health challenge, with more than 4 million cases going undiagnosed or unreported annually, according to the World Health Organization (WHO). This collaboration aims to address these limitations by developing affordable, point-of-care diagnostic tools that do not rely on high-quality laboratory systems, which are often unavailable in low-resource settings.

Breath-Based Diagnostic

FDA and Gates Foundation Collaborate to Enhance Disease Detection in Underserved Populations

The collaboration between the FDA and the Gates Foundation highlights the shared interest in improving disease detection in underserved populations. By creating new analytical methods and tools, the initiative aims to facilitate the development of diagnostic devices that can be used in a variety of settings, including rural and remote areas. This approach aligns with the broader goals of both organizations to enhance global health and reduce disparities in healthcare access.

As the FDA and Gates Foundation continue to develop and validate these new methods and tools, the potential for breath-based diagnostics to revolutionize disease detection grows. The success of this initiative could lead to the development of a range of diagnostic devices that are affordable, easy to use, and capable of being deployed in diverse healthcare settings. This, in turn, could significantly improve health outcomes for millions of people worldwide, particularly those in medically underserved communities.

The FDA’s partnership with the Gates Foundation to support breath-based diagnostic development represents a significant step forward in the fight against diseases like TB. By focusing on the creation of new analytical methods and tools, the collaboration aims to provide developers with the resources they need to produce effective and affordable diagnostic tests. This initiative not only addresses the immediate need for improved disease detection in underserved populations but also paves the way for the development of next-generation diagnostic devices that could transform global healthcare.

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Resource: Food and Drug Administration, June 27, 2024

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