Breath Diagnostics

Executive Summary

Breath Diagnostics is a private US company developing the OneBreath™ platform, a non-invasive breath test for early lung cancer detection. The technology captures and chemically transforms volatile organic compounds (VOCs) from a single exhalation, analyzing them via liquid chromatography-mass spectrometry (LC-MS). Current lung cancer screening relies on low-dose CT scans, which have high false-positive rates, radiation exposure, and limited accessibility. OneBreath aims to offer a fast, accurate, and cost-effective alternative, potentially increasing screening compliance and enabling earlier diagnosis. Founded in 2019 and headquartered in Austin, Texas, the company is in early development stages, with no disclosed funding or revenue. Its core innovation lies in a proprietary microreactor that stabilizes VOCs for sensitive detection, differentiating it from other breath analysis approaches. If successful, OneBreath could address a significant unmet need in cancer diagnostics, but the technology remains unvalidated in large-scale clinical trials.

Upcoming Catalysts (preview)

• Q4 2026Pivotal Clinical Trial Results40% success
• Q2 2026FDA Breakthrough Device Designation60% success
• TBDStrategic Partnership or Licensing Deal50% success