Breath Diagnostics, a leader in breath-based molecular diagnostics powered by patented microreactor capture technology, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its OneBreath™ platform.
The designation applies to OneBreath™ as an in vitro diagnostic intended for the qualitative assessment of exhaled volatile organic compounds (VOCs) from a single pre-operative breath specimen. The test is designed to aid in perioperative risk stratification and management of adult patients scheduled for elective cardiac surgery by identifying those at elevated risk of developing postoperative pneumonia (POP).
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The FDA grants Breakthrough Device designation to a limited set of qualifying medical devices that have the potential to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases than current options. Devices accepted into the program receive prioritized FDA interaction and enhanced communication to support more efficient development and review, with the goal of providing patients and healthcare providers more timely access to innovative technologies while maintaining the FDA’s rigorous standards. This Breakthrough Device Designation is based on evidence demonstrating that OneBreath™ has the potential to identify patients at elevated risk of developing postoperative pneumonia through qualitative molecular analysis of exhaled breath.
“We believe this designation marks an important step forward for the OneBreath™ platform and reflects the emerging role of breath-based molecular diagnostics in addressing unmet clinical needs,” said Ivan Lo, CEO of Breath Diagnostics, Inc. “To our knowledge, OneBreath™ is the first FDA Breakthrough Device to apply LC-MS–based molecular analysis to human breath. Most breath technologies rely on indirect signals or sensors. Our platform operates at the molecular level, directly measuring defined chemical species with high analytical specificity, orthogonal validation, and broad linearity.”
OneBreath™ features a single-breath sampling design in which a patient provides one exhaled breath that is subsequently analyzed using liquid chromatography–mass spectrometry (LC-MS). The analytical workflow is designed to be completed in approximately ten minutes, supporting efficient integration into perioperative clinical settings without adding burden to patients or care teams.
“For years, researchers and clinicians have recognized that breath may provide one of the earliest and most dynamic readouts of human biology,” Lo added. “A single exhaled breath is simple, fast, and entirely non-invasive — qualities that may make patients more willing to undergo testing compared with blood draws or other sample types such as urine or stool. Unlike blood, which is filtered and metabolized by organs such as the liver and kidneys, breath contains volatile organic compounds associated with biological processes, including inflammation and metabolic activity. By lowering barriers to testing, OneBreath™ has the potential not only to detect disease risk earlier, but also to enable more frequent monitoring.”
The OneBreath™ platform captures orthogonal layers of molecular evidence from exhaled VOCs, enabling qualitative assessment across a wide dynamic range. Breath Diagnostics, Inc. believes this architecture positions OneBreath™ not as a single-use assay, but as a scalable platform technology potentially capable of supporting future clinical applications.
As stated in the FDA grant, OneBreath™ is intended to be used in conjunction with clinical evaluation and standard risk assessment tools, does not identify specific pathogens, and is not intended to diagnose pneumonia. Analysis is performed by qualified laboratory personnel in an appropriately equipped clinical laboratory, and the device is for prescription use only.
Breath Diagnostics, Inc. plans to leverage the Breakthrough Devices Program to continue working closely with the FDA as it advances OneBreath™ through its development and regulatory pathway. However, Breakthrough Device designation is based on preliminary data and does not guarantee that the FDA review and approval process will be shortened or that an application will be approved.
