Abstract 2442: Blood based novel mRNA genomic test, for screening, early detection, prognosis and monitoring of prostate cancer using a multi-center study

Abstract Background: Current screening tools, including prostate-specific antigen (PSA) and clinico-pathologic parameters, have limitations in the diagnosis and prognosis of prostate cancer. This study examined whether genomic biomarkers can improve screening and monitoring of prostate cancer. Methods: We identified a panel of 25 prostate cancer-related genes through rigorous bioinformatics, computational analyses and genetic testing. These tests, developed by Geneverify Inc. (Hayward, CA; U. S. patent # 10801072 and 10822661) were utilized and optimized by qRT-PCR to determine the diagnostic and prognostic ability of prostate cancer using blood and tissues. The log2-fold increase in gene expression was used to assign the risk score to individual patients. ROC (receiver operator characteristic), AUC (area under ROC curve), and calibration curves were generated to display the overall performance and discrimination ability to separate cancer and non-cancer specimens. Results: A total of 445 prostate cancer patients (135 blood and 310 tissue samples) and 130 normal samples were analyzed in this study. The eligibility criteria were to collect blood and surgical specimens from patients with prostate cancer. The study endpoints were to analyze mRNA genomic profiling and correlate with clinico-pathologic parameters of the patients. In the blood, a 25-panel gene-set separated prostate cancer patients (n=135) from non-cancer (n=30), AUC = 0. 906 sensitivity = 90% and specificity = 91%. Assessment of tissue specimens from benign (n=100) and cancer patients (n=310) demonstrated similar results with AUC=0. 9514 sensitivity=95% and specificity=94%. Interestingly, patients with Gleason grades more than 7 showed higher expression of these genes compared to Gleason Grades less than 7, suggesting the prognostic ability of the gene-set. When we compared the gene expression in blood verses tissues, there were similar patterns, suggesting that blood can be used for screening, diagnosis and risk assessment of prostate cancer. Conclusions: To our knowledge, this is the first study to investigate the role of mRNA-based genomic signatures for screening, early diagnosis and prognosis of prostate cancer using blood samples. Our results suggest that blood mRNA-genomic profiling developed by Geneverify has the ability to diagnose prostate cancer and stratify patients into distinct prognostic groups, which in turn help in making better treatment strategies. Citation Format: Yutaka Hashimoto, Shiv Verma, Guoren Deng, Dharam P. Chauhan, Sujit Nair, Dimple Chakravarty, Hirofumi Yoshino, Junya Arima, Shuichi Tatarano, Yutong Liu, Koji Hatano, Yogesh Shivakumar, Mithua Ghosh, Krishnappa Raghunath, Chitra Chandran, Narasimhan Ragavan, Hideki Enokida, Norio Nonomura, KC Balaji, Sudhir Rawal, Ashutosh Tewari, Rajvir Dahiya, Sanjay Gupta. Blood based novel mRNA genomic test, for screening, early detection, prognosis and monitoring of prostate cancer using a multi-center study abstract. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts) ; 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84 (6Suppl): Abstract nr 2442.