Translation of Interferometric-based Free-solution Assay Methodology

Project Summary: Lung cancer is the leading cause of cancer-related deaths in the United States. Low dose chest computed tomography (CT) screening programs that target high-risk individuals can reduce lung cancer-specific mortality by 20% and overall mortality by 6.9%. There is a growing movement to implement this life saving screening into routine practice, with endorsements from the U.S. Preventive Services Task Force, the American Thoracic Society, and the American College of Chest Physicians, and a willingness from payers to provide reimbursement. Yet, numerous challenges still exist to realize early detection and improved outcomes for lung cancer, including: a) how to diagnosis lung cancer patients with indeterminate pulmonary nodules (IPNs); b) how to determine recurrence after therapy; and c) how to position biomarker use prior or alongside chest CT screening to decrease the cost and rates of false positive tests. The availability of a rapid, high sensitivity detection method to improve the quantification of biomarkers has the potential to revolutionize management of patients with IPNs. Under this Phase I STTR, we propose to take the next logical steps toward commercial translation of our novel and patented technologies, the free-solution assay (FSA) and the compensated interferometric reader (CIR) that has been shown to potentially improve IPN diagnosis. The FSA-CIR methodology is potentially transformative with respect to biomedical research and medicine, representing the only solution-phase, label-free molecular interaction measurement methodology with sensitivity comparable to, or better than, fluorescence, and compatible with a wide range of complex matrices. These properties have enabled FSA-CIR to be used to address previously challenging or intractable applications ranging from enhanced lung cancer detection, as proposed here, to improved in-vitro in-vivo correlations for first in human dosing, to the rapid quantification of low abundance chemicals in human samples, including neonatal opioids in urine and chemical nerve agents in urine and serum.Translation of Interferometric-based Free-solution Assay Methodology for Lung Cancer Diagnosis Project Narrative: Diagnosis of lung cancer presents a significant challenge, resulting in morbidity and management costs of $28 billion/year in the U.S., particularly for patients with indeterminate pulmonary nodules (IPNs). Here, we show that when applying a new test for measuring a blood-based circulating tumor marker to a 225 patient cohort, it is possible to significantly improve patient stratification and diagnostic potential of the biomarker. The proposed approach is patented and commercially viable, capitalizing on the increased performance of a mix-and-read test that is rapid, label-free, requires only a drop of serum and is enabled by simple diode-laser based reader.