Breath Diagnostics, Inc.
Breath Diagnostics, Inc. (“Breath-Dx” or “the Company”), is a medical-device diagnostics company developing a novel, patented breath analysis system to quantify cancer specific markers in exhaled breath. The Company’s proprietary technology, OneBreath™, offers a unique solution by providing accurate, affordable, and safe lung cancer detection by analyzing a single exhaled breath. The Company’s innovative platform can selectively detect a spectrum of predictive markers and therefore has the potential to expand into other cancer indications as well as a variety of other disease states.
Company details
Find locations served, office locations
- Business Type:
- Manufacturer
- Industry Type:
- Medical Equipment
- Market Focus:
- Globally (various continents)
- Year Founded:
- 2014
About Us
Current lung cancer diagnosis is expensive, inaccurate, and potentially harmful to patients. OneBreath™ offers a solution which is easily administered, readily deployable, non-invasive, and provides better accuracy than current technologies, all within 24 hours. The Company’s technology is ideally suited for application in three lung cancer related indications: (1) as a primary screen for detection of lung cancer; (2) to differentiate benign from malignant pulmonary nodules; and (3) to monitor for recurrence after surgical resection of lung cancer. Breath-Dx has cumulatively studied 800 subjects using the breath analysis technology. The data from these various studies have been disclosed in 10 peer-reviewed publications representing the most of any breath analysis company. In one of pre-clinical study consisting of 204 subjects, OneBreath™ demonstrated a sensitivity of 94% and a specificity of 86% in detecting lung cancer. In another study, Breath-Dx’s technology displayed a 77% specificity in differentiating malignant from benign pulmonary nodules, illustrating twice the specificity of positron emission tomography (PET) scans (39%), a commonly used diagnostic tool for lung cancer. The breath cancer markers normalized after surgical removal of the tumor, thereby validating the markers as indicators for cancer. The Company is preparing for independent clinical trials which it anticipates beginning in Q1/Q2 2020.
Breath Diagnostics, Inc. is a Louisville, Kentucky-based company formed to commercialize its revolutionary OneBreath™ technology. The breath analysis platform was originally conceived, developed, and patented by scientists at the University of Louisville, which continues to support research and development activities. Breath-Dx is currently seeking capital in a Bridge Financing round via Convertible Preferred Notes to support the launch of pivotal clinical trials in collaboration with Mayo Clinic Laboratories and Parexel, development of scalable manufacturing and management infrastructure.
Company
Breath Diagnostics, Inc. (BDx) is a Louisville, Kentucky-based company formed in October 2014 to commercialize its revolutionary OneBreath™ technology. The company’s mission is to implement breath analysis technology globally to provide early cancer detection and reduce patient exposure to expensive, high-risk medical procedures.
The corporate objective is to launch OneBreath™ for lung cancer detection and ultimately expand the use of this technology to detect other cancers and diseases. The first objective is to complete FDA enabling trials. The company will develop its corporate footprint in collaboration with one or more CLIA certified labs, which will serve as a partner in the development of BDx’s technology.
Market
According to National Lung Screening Trial, ~24% of the CT scanned individuals show pulmonary nodules; however, only a minority of these nodules are >8 mm in size. Patients with nodules of this size are considered to be at high risk for malignancy, depending on clinical history and nodule characterization. We estimate that ~400,000 patients will require some form of follow up studies to evaluate these high-risk, indeterminate nodules. OneBreath™ can provide a differential test for cancer in these patients. Given the findings from the National Lung Screening Trial (NLST), the use of CT scanning as a screening tool for lung cancer is expected to increase, leading to the discovery of many pulmonary nodules.
The largest market for the OneBreath™ test would be for LC screening, which would have worldwide application. As mentioned above, 10 million persons in the US meet CMS criteria for LC screening (i.e., ≥55 years of age and 30 pack-year history of smoking). Combining the US market with those of Europe and China, 100 million individuals would be candidates for screening. We have extensively investigated the largest market, China, and have made early and significant contacts at the corporate and academic levels.
Our Mission
Our mission is to globally implement breath analysis technology to provide early detection for cancers and reduce patient exposure to costly, high risk medical procedures.