FDA Breakthrough Designation Granted to Breath Diagnostics’ OneBreath Platform

Breath Diagnostics Inc. has earned U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its OneBreath platform.

The designation applies to OneBreath as an in-vitro diagnostic to qualitatively assess exhaled volatile organic compounds (VOCs) from a single pre-operative breath specimen. The test is designed to determine perioperative risk stratification and manage adult patients scheduled for elective cardiac surgery by identifying those with a higher risk of developing postoperative pneumonia (POP).

“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,” Breath Diagnostics CEO Ivan Lo said. “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.”

The FDA grants Breakthrough Device designation to a limited set of qualifying medical devices that may provide 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, to provide 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 could potentially identify patients with a higher risk of developing postoperative pneumonia through qualitative molecular analysis of exhaled breath.

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 10 minutes, supporting efficient integration into perioperative clinical settings without burdening 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 executives believe this architecture positions OneBreath not as a single-use assay, but as a scalable platform technology capable of supporting future clinical applications.

As stated in the FDA grant, OneBreath is 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 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 the FDA review and approval process will be shortened or that an application will be approved.

Breath Diagnostics is a medical technology company developing non-invasive diagnostic solutions based on advanced breath analysis. Its OneBreath platform integrates patented microreactor-based breath capture technology with liquid chromatography–mass spectrometry (LC-MS) and analytical software to evaluate molecular signatures from a single exhaled breath. The company is focused on developing technologies intended to support clinical risk assessment and decision-making.