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, 10M 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.