Breath Diagnostics’ OneBreath Platform Receives FDA Breakthrough Device Designation
Breath Diagnostics said the FDA granted Breakthrough Device Designation to its OneBreath platform for pre-operative assessment of postoperative pneumonia risk in adults undergoing elective cardiac surgery. The single-breath test analyzes exhaled volatile organic compounds using LC-MS and is intended for use with clinical evaluation and standard risk assessment tools.
Breath Diagnostics, Inc. said the U.S. Food and Drug Administration 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 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.
The company said the 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. Devices accepted into the program receive prioritized FDA interaction and enhanced communication to support more efficient development and review.
OneBreath™ features a single-breath sampling design in which a patient provides one exhaled breath that is subsequently analyzed using liquid chromatography–mass spectrometry. The analytical workflow is designed to be completed in approximately ten minutes, supporting integration into perioperative clinical settings.
The CEO said OneBreath™ is the first FDA Breakthrough Device to apply LC-MS-based molecular analysis to human breath. The platform operates at the molecular level, directly measuring defined chemical species with high analytical specificity, orthogonal validation, and broad linearity, according to the company.
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.
The company said it plans to continue working with the FDA as it advances OneBreath™ through its development and regulatory pathway. It also said 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.