Abstract A17: A blood test for early detection of lung cancer using a mixed panel of tumor proteins and autoantibodies.

Lung cancer is the second most common non-cutaneous cancer and a leading cause of cancer-related mortalities worldwide, resulting in over 156,000 deaths per year in the United States alone (1). Tobacco use has been identified as the primary causal factor for lung cancer and is thought to account for some 90% of cases. Thus, individuals over 50 years of age with a smoking history of greater than 20 pack-years have a 1 in 7 lifetime risk of developing the disease. 20/20 GeneSystem9s PAULA test (Protein Assays Utilizing Lung Cancer Analytes), a multiplex immunoassay clinical blood test that detects four tumor proteins and autoantibodies, determines the risk that lung cancer is present in asymptomatic individuals from the high risk population described above. The test has been developed and tested using over 1,500 patient samples, including patients from 6 different regional cancer centers as well as age- and smoking history-matched controls. Here we report a new retrospective study of PAULA test using a total of 380 patients from 3 different cohorts, consisting of 190 confirmed diagnoses of lung cancer and 190 age- and smoking history matched controls. The PAULA test demonstrated 74% clinical sensitivity and 80% specificity, with an AUC value of 0.85 using Receiver Operating Characteristic (ROC) analysis. This study confirms the value of using both tumor proteins and autoantibodies in the early detection of lung cancer, and is the first demonstration of a diagnostic multiplex immunoassay using this kind of mixed panel. We believe that the clinical performance of the PAULA test makes it suitable for use as an aid to determine which high-risk patients need to be directed to appropriate non-invasive diagnostic follow-up, especially chest CT scan for patients at high-risk for lung cancer. Citation Format: Victoria Doseeva, Juliana Woodcock, James Freedy, William James, Vladimir Knezevic. A blood test for early detection of lung cancer using a mixed panel of tumor proteins and autoantibodies. [abstract]. In: Proceedings of the AACR-IASLC Joint Conference on Molecular Origins of Lung Cancer; 2014 Jan 6-9; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2014;20(2Suppl):Abstract nr A17.