OneBreath™ for Lung Cancer Detection
Early-stage lung cancer screening
Clinical ValidationActive
Key Facts
Indication
Early-stage lung cancer screening
Phase
Clinical Validation
Status
Active
Company
About 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.
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