The largest market for the OneBreath™ test is LC screening, which would have worldwide application.  Nearly 10 million individuals in the US are considered ‘at-risk’ (i.e., ≥55 years of age and 30 pack-year history of smoking) and are eligible for LC screening; worldwide, more than 100 million individuals would be candidates for screening.  Next, according to the National Lung Screening Trial (NLST), ~400,000 patients with indeterminate pulmonary nodules (IPN) (nodule size 8-30 mm) will require some form of follow up studies to evaluate their high-risk, indeterminate nodules, annually. OneBreath™ can provide a differential test for cancer in these patients.  Finally, given that ~415,000 Americans living today have been diagnosed with LC at some point in their lives, we estimate that at least 250,000 patients are within five years of LC resection and will require, as often as quarterly, follow-ups to monitor for recurrence.

Current radiography approaches for detecting LC have difficulty in distinguishing between benign processes and malignancy.  According to NLST nearly 96% of the nodules evident on a CT scan were not cancer.  Although a subjective clinical analysis of the nodule/s may provide some differentiation of benign diseases from malignancy, a large proportion of these nodules require follow-up radiographic tests and/or invasive biopsies.  The morbidity associated with these patients who have benign disease is incalculable and the expense is estimated to be $600 million/year for Medicare patients alone.  Clearly an affordable, non-invasive, and accurate method of LC diagnosis is needed to facilitate appropriate treatment for patients as well as to provide substantial savings to the payers of healthcare. The OneBreath™ test will alter the current diagnostic pathway to eliminate a large proportion of unnecessary invasive or radiographic testing.