In search of a breath-print 

Your breath is more potent than you can imagine.

So much so that the FDA and the Bill and Melinda Gates Foundation have partnered up to support the development of breath-based diagnostics.

The so-called “breath-print” as a biomarker could be the key to improve disease detection in underserved populations and remote areas—especially when it comes to tuberculosis (TB)

With this story, we’re diving into the frontlines of TB innovation and the field of biomarkers.

Illustration by Mary Delaney
Illustration by Mary Delaney

What’s in a breath?

The new collaboration creates a $1.9 million Gates Foundation grant for the FDA and the Foundation to create new analytical methods supporting the development of these novel diagnostic devices.

To do so, they’re building a breath database. This database will log breath samples from healthy individuals and people infected with the bacterium that causes tuberculosis. Using this data, the collaborators are developing criteria for chemical identification and classification confidence. They’re also building a web application to analyze mass spectroscopy data.

Overall, these projects aim to establish a new breath-based biomarker for TB—the basal-level breath-print.

What is a breath-print? It’s a quantitative measurement of the molecules in a person’s exhaled breath. In practice, it’s a non-invasive molecular diagnostic method.

Breath-prints are already being used in other areas of disease detection and classification, from pulmonary hypertension to liver cirrhosis. In 2022, the FDA even awarded an emergency use authorization to a suitcase-sized breathalyzer for COVID-19 detection.

The goal of all this work? Better, more affordable tests for use in remote areas, where complex and expensive diagnostic equipment is scarce.

Earlier this year, the Gates Foundation awarded a $6.5 million grant to U.K.-based Owlstone Medical, which develops a “breath biopsy” sample capture device. The grant is intended to further research into biomarker identification for infectious diseases, such as HIV and TB.

Billy Boyle, co-founder and CEO at Owlstone Medical, said: “Early diagnosis is a critical determinant of health outcomes. By enabling swift and non-invasive detection of disease, breath analysis has the potential to save lives and dramatically reduce the burden of illness in resource-constrained settings.”

Increasing interest in TB innovation

This project builds upon the Gates Foundation’s longstanding commitment to TB detection. In 2012, the Foundation funded $7.7 million worth of grants to identify TB diagnostic biomarkers in low-resource settings.

The innovation tackles an area of high need. An estimated 4 million TB cases worldwide go undiagnosed or unreported. For the most part, these cases fall through the cracks because the patients live in areas without the kind of high-level diagnostic equipment used for gold-standard TB testing.

We previously discussed the challenges of TB testing when a bone-graft-related outbreak underscored the pitfalls of available testing protocols in our own industry.

TB mitigation investment is inequitably distributed across the globe. So, any innovation that can help provide simple, affordable tools to the places hit hardest and most resource-starved is a worthwhile pursuit.

Our perspective: Next-generation biomarkers

Every time we look around, it seems like there’s a novel biomarker on the innovation scene. 

Theoretically, any aspect of your bodily function that can be quantified and mapped can turn into a biomarker—from your sweat to your voice. New criteria for diagnosing and monitoring Alzheimer’s disease were recently published based on—you guessed it—novel biomarkers. There’s even a movement toward the harnessing of so-called digital biomarkers.

Medical innovators and researchers are rightfully focused on new biomarker identification. They’re key to more accurately and efficiently diagnosing all sorts of medical conditions—they unlock precision medicine in a wide variety of channels. 

Entrepreneurial innovators are churning out a wealth of apps and other self-tracking tools based on new kinds of biomarkers, giving people more insights into their health. On the other hand, consumers need to be better informed about what kinds of biomarkers are scientifically validated to not fall prey to digital health tools that may claim more than they can deliver. In this arena, user-friendliness must pair with sound science and clinical relevance to truly give people the rich insights into their health that they deserve.

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