Breath Diagnostics

Breath Diagnostics is pioneering a novel, non-invasive diagnostic platform that analyzes breath metabolites to detect lung cancer with high sensitivity and specificity. Its core OneBreath™ technology employs patented derivatization chemistry to stabilize VOCs for sensitive LC-MS analysis, offering a 30-second test that is radiation-free and potentially more accessible than imaging. The company has achieved FDA Breakthrough Device Designation for a pre-operative pneumonia risk assessment application and is advancing its lung cancer screening program through clinical validation, positioning itself to address a critical unmet need in early detection.

OneBreath™ platform: A breath diagnostics system using a proprietary microreactor to chemically derivatize volatile organic compounds (VOCs) from exhaled breath into stable analytes for highly sensitive detection and quantification via liquid chromatography-mass spectrometry (LC-MS).

Breath Diagnostics competes in the early cancer detection space, primarily against low-dose CT imaging and emerging multi-cancer early detection (MCED) blood tests (e.g., Galleri). Its direct differentiation is the non-invasive, metabolomic focus on breath and the specific targeting of lung cancer. Competition also includes other breath analysis companies and point-of-care diagnostic developers.