Breath Diagnostics
Breath Diagnostics is a Louisville, Kentucky-based medical technology company developing the OneBreath platform, a non-invasive breath diagnostic using patented microreactor chemistry and UHPLC-MS to detect lung cancer, assess pneumonia risk, and screen for respiratory diseases from a single exhaled breath.
- Company typePrivate
- Founded2015
- HeadquartersProspect, United States
- Headcount1–10
- GTM typeB2B
- OfferingHardware or Manufacturing
What Breath Diagnostics does
Breath Diagnostics Inc. is a privately held, development-stage medical technology company founded in 2015 and headquartered in Louisville, Kentucky. The company is developing the OneBreath platform, a non-invasive in vitro diagnostic that captures and quantifies volatile organic compounds (VOCs) from a single exhaled breath to detect lung cancer, assess pre-operative pneumonia risk, and screen for other respiratory diseases such as idiopathic pulmonary fibrosis and COVID-19.
The OneBreath platform is built on a patented silicon microreactor that uses aminooxy chemistry to selectively and covalently capture carbonyl VOCs from exhaled breath, converting them into stable cationic adducts for analysis by ultra-high-performance liquid chromatography coupled with mass spectrometry (UHPLC-MS). A single 30-second breath sample is processed in under 10 minutes, with reported analytical performance of greater than 10^6 dynamic range, pptv-level sensitivity, R² greater than 0.99, and clinical performance of 94% sensitivity and 85% specificity for lung cancer detection across 800+ trial patients. The platform received FDA Breakthrough Device Designation in February 2026 for pre-operative pneumonia risk assessment and is reportedly the first LC-MS-based molecular breath test to receive this designation. Multiple global patents protect the underlying microreactor chemistry, aminooxy capture reagents, and methods for cancer detection via breath carbonyl compounds.
The company is pre-revenue and pre-FDA approval, with a planned commercialization pathway that begins with a CLIA laboratory developed test before pursuing full FDA IVD clearance. The intended go-to-market focuses initially on pulmonology practices and cancer centers leveraging clinical validation data and key opinion leader relationships, with subsequent expansion to primary care, pharmacies, and community health centers. Revenue streams are expected to include per-test fees from CLIA laboratory services, eventual commercial IVD product sales, and potential licensing of the platform's core chemistry to applications beyond lung cancer. The company has raised approximately $7.7 million in prior capital and is currently conducting a Regulation CF crowdfunding campaign of up to $3 million at a $32.1 million pre-money valuation.
Breath Diagnostics firmographics
Firmographics- Name
- Breath Diagnostics
- Legal name
- Breath Diagnostics Inc.
- Website
- https://breathdiagnostics.com
- Company type
- Private
- Founded year
- 2015
- Operating status
- Operating
- Headcount range
- 1–10 employees
- Short description
- Breath Diagnostics is a Louisville, Kentucky-based medical technology company developing the OneBreath platform, a non-invasive breath diagnostic using patented microreactor chemistry and UHPLC-MS to detect lung cancer, assess pneumonia risk, and screen for respiratory diseases from a single exhaled breath.
- Ownership category
- akta.pro rank
Breath Diagnostics industry classification
Industry- Product category
- Molecular Cancer Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)
- akta.pro primary industry
- Blood Oxygen & Respiratory Monitoring (Pulse Oximetry, Capnography, Spirometry) (HLAHACAD)
- akta.pro secondary industries
- Pulmonary Function Testing (PFT) & Respiratory Diagnostics (HLAKANAC), Pulmonary Function & Respiratory Diagnostic Centers (PFT/Spirometry) (HLAFAKAJ)
Keywords
Where Breath Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Prospect
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Breath Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Infrastructure, Personnel, Operations, Marketing or Sales
Revenue model
- OneBreath™ Diagnostic Tests: The company plans to generate revenue through sale of OneBreath diagnostic tests, initially through CLIA laboratory services and subsequently as a commercial IVD product following FDA approval. Medicare reimbursement for lung cancer screening has already been established, creating a clear path to revenue.
- Platform Technology Licensing: The company notes potential applications beyond lung cancer for pneumonia, COPD, tuberculosis, and other respiratory diseases, which may create licensing or partnership revenue opportunities.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Diagnostic test pricing (commercial) |
Go-to-market motion1 record
Distribution channels4 records
Marketing channels6 records
Breath Diagnostics product offering
Product offeringCore offering
Breath Diagnostics develops the OneBreath™ diagnostic platform, a non-invasive in vitro diagnostic that captures and analyzes volatile organic compounds (VOCs) from a single exhaled breath to detect lung cancer and other respiratory diseases. The platform uses a patented silicon microreactor with aminooxy chemistry to derivatize carbonyl VOCs into stable cationic adducts, followed by ultra-high-performance liquid chromatography-mass spectrometry (UHPLC-MS) analysis, achieving 94% sensitivity and 85% specificity across 800+ patients in clinical trials.
Product overview
Breath Diagnostics offers OneBreath™, a single unified non-invasive diagnostic platform that analyzes exhaled breath for disease detection. The platform uses patented microreactor chemistry to capture and derivatize volatile organic compounds (VOCs), which are then quantified using UHPLC-MS analysis. Originally developed for lung cancer screening, the technology has demonstrated clinical validity for detecting multiple conditions including pneumonia, idiopathic pulmonary fibrosis (IPF), and COVID-19. The platform delivers results in under 10 minutes from a single 30-second breath collection, offering significant advantages over traditional GC-MS methods that require 15-30 minutes of sampling and up to an hour of analysis.
Differentiator
Problem solved
Functional benefit
Products and services
- OneBreath™ Diagnostic Platform A non-invasive in vitro diagnostic platform that analyzes exhaled volatile organic compounds (VOCs) from a single breath to detect lung cancer and other respiratory diseases (pneumonia risk, IPF, COVID-19). The platform uses proprietary microreactor derivatization technology combined with UHPLC-MS to deliver 94% sensitivity and 85% specificity in lung cancer detection across 800+ patients in clinical trials, with results in under 10 minutes from a 30-second breath collection.
Quantifiable outcome
- 94% sensitivity and 85% specificity for lung cancer detection in clinical trials with over 800 patients
- +5 more outcomes
Companies that use Breath Diagnostics
Customer profileSegments4 records
Ideal customer profiles3 records
Breath Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability2 records
Feature5 records
Breath Diagnostics partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core and minor.
- Waters CorporationcoreBreath Diagnostics installed an advanced mass spectrometry system from Waters Corp in its laboratory in late 2025. The new system enhances detection sensitivity, data quality, and reproducibility for breath analysis, strengthening the company's analytical capabilities for the OneBreath platform.
- Life Science IntelligenceminorLife Science Intelligence, a medtech research firm, recognized Breath Diagnostics in its 2025 Emerging Innovators Report for its non-invasive OneBreath lung cancer breath test, placing the company among over 500 innovators from 36 countries.
- University of Louisville / UofL HealthcoreSeveral company founders (Xiao-An Fu, Michael Nantz, Victor van Berkel) are affiliated with the University of Louisville. Dr. van Berkel serves as Chief of Thoracic Surgery at UofL Health and leads clinical trials through the Brown Cancer Center. This academic-clinical partnership has driven technology development and clinical validation.
Scale indicators7 records
Recent moves6 records
Expansion highlights6 records
Breath Diagnostics competitors and assessment
Company assessmentDirect peers
- Owlstone Medical: UK-based breath biopsy company developing non-invasive breath tests for early cancer detection (including lung cancer) and other diseases using VOC analysis. Closely comparable in target indication, breath-based technology approach, and clinical stage.
- Menssana Research: Pioneer in breath-based diagnostic testing for lung cancer and other diseases using proprietary breath collection and analysis methods. Directly comparable as a breath diagnostics company focused on respiratory and oncologic indications.
Emerging players
- Breathtec Biomedical: Early-stage developer of breath-based diagnostic tests for lung cancer and respiratory diseases, focused on VOC biomarker analysis. Comparable as a smaller-scale breath diagnostics player targeting similar clinical applications.
- Noze (formerly ScentAware): Digital health company developing breath-based disease detection technology using AI and sensor arrays. Comparable in the breath diagnostics category, though using different underlying sensor/AI approach versus Breath Diagnostics' LC-MS chemistry.
Broad incumbents
- Philips Respiratory: Major medtech incumbent with a broad respiratory diagnostics and monitoring portfolio (spirometry, pulmonary function testing). Comparable as an established respiratory diagnostics provider that OneBreath would compete against or partner with.
- Thermo Fisher Scientific: Global leader in mass spectrometry and analytical instruments used in clinical diagnostics and life sciences research. Comparable both as a potential MS instrument supplier to Breath Diagnostics and as a broad incumbent in the IVD/substance manufacturing space.
- Agilent Technologies: Major analytical instrument manufacturer including mass spectrometry and chromatography systems used in clinical diagnostics and research. Comparable as a potential instrument partner/competitor and broad incumbent in lab analytical instruments.
- Hologic: Major women's health and diagnostics company with growing respiratory and molecular diagnostics portfolio (including COVID-19 and pneumonia testing). Comparable as a broad incumbent in diagnostic test commercialization targeting pulmonology and infectious disease.
Others
- Waters Corporation: Mass spectrometry and UHPLC instrument manufacturer and existing technology partner to Breath Diagnostics (installed advanced MS system at Breath Diagnostics' lab in late 2025). Comparable as an enabling technology supplier for the OneBreath platform.
- Cleveland Clinic (Lung Cancer Screening Program): Major academic medical center operating one of the largest lung cancer screening programs in the U.S. and home to Director Jeff Rich. Comparable as a key clinical reference site and potential adoption partner for OneBreath in pulmonology and thoracic surgery.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Breath Diagnostics social profiles
Digital presenceBreath Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Breath Diagnostics leadership team
Management profileNumber of profiles
Profiles7 records
Breath Diagnostics funding detail
Funding detailFunding overview
Funding rounds3 records
Investors3 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Breath Diagnostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Breath Diagnostics
What does Breath Diagnostics do?
Breath Diagnostics develops the OneBreath™ diagnostic platform, a non-invasive in vitro diagnostic that captures and analyzes volatile organic compounds (VOCs) from a single exhaled breath to detect lung cancer and other respiratory diseases. The platform uses a patented silicon microreactor with aminooxy chemistry to derivatize carbonyl VOCs into stable cationic adducts, followed by ultra-high-performance liquid chromatography-mass spectrometry (UHPLC-MS) analysis, achieving 94% sensitivity and 85% specificity across 800+ patients in clinical trials.
Is Breath Diagnostics a public or private company?
Breath Diagnostics is a private company. It is classified as venture growth investor backed and is currently operating.
When was Breath Diagnostics founded?
Breath Diagnostics was founded in 2015. It employs 1 to 10 people.
Where is Breath Diagnostics based?
Breath Diagnostics is headquartered in Prospect, United States, in the North America region.
How does Breath Diagnostics make money?
Two revenue lines are on record. OneBreath™ Diagnostic Tests are the primary driver. The others are platform Technology Licensing.
Who are Breath Diagnostics's main competitors?
Direct peers on record are Owlstone Medical and Menssana Research. Emerging players are Breathtec Biomedical and Noze (formerly ScentAware). Broad incumbents are Philips Respiratory, Thermo Fisher Scientific, Agilent Technologies and Hologic. Others are Waters Corporation and Cleveland Clinic (Lung Cancer Screening Program).
Does Breath Diagnostics have an API?
No public API is recorded for Breath Diagnostics.
What industry is Breath Diagnostics in?
Breath Diagnostics's product category is Molecular Cancer Diagnostics. Its primary akta.pro industry code is HLAHACAD, Blood Oxygen & Respiratory Monitoring (Pulse Oximetry, Capnography, Spirometry), with a secondary code of HLAKANAC, Pulmonary Function Testing (PFT) & Respiratory Diagnostics. Its NAICS code is 325413 and its SIC code is 2835.