A novel mRNA genomic technology for precision medicine, early cancer diagnosis, prognosis, treatment follow-up and cancer gene therapy

Background: Current screening methods, have limitations in the diagnosis and prognosis of prostate cancer. This study examined whether mRNA-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. (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.

Results: A total of 419 prostate cancer patients from 9 different hospitals (135 blood and 284 tissue samples) and 130 normal samples were analyzed in this study. The study endpoints were to analyze mRNA genomic profiling and correlate with clinicopathologic parameters of the patients. In the blood, a 25-panel gene-set separated prostate cancer patients from non-cancer, AUC = 0.906 [sensitivity = 90% and specificity = 91%]. Assessment of tissue specimens from benign and cancer patients demonstrated similar results with AUC = 0.9514 [sensitivity = 95% and specificity = 94%]. Interestingly, patients with Gleason grades >7 showed higher expression of these genes compared to Gleason Grades < 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.

Rajvir Dahiya holds Ph.D. in Experimental Medicine from Post Graduate Institute of Medical Education and Research Chandigarh, India, post-doctoral fellowship in medical oncology research from the University of Chicago Pritzker School of Medicine, M.D. from the Kagoshima University Faculty of Medicine, Kagoshima, Japan and D.Sc. from the Osaka University Graduate School of Medicine, Osaka, Japan. He became director of Oncology Urology Oncology Research Center at the UCSF/VAMC in 1991. After 34 years of service, he retired as a Professor Emeritus and Director of Urology Research Center. Dahiya has published more than 550 original research manuscripts. Dahiya’s world ranking in medicine is 5690 (top 0.15%) and USA ranking is 3003 (top 1%) with more than 38,795 research citations and D-index of 108, i10-index of 325 in 2026. He has written books and holds multiple patents in oncology. Based on the NIH and VA data base NIH Reporter and Grantome, Dahiya's research programs were supported (99 times awarded) by the NIH and VA. Dahiya served for 25 years as a chairman and scientific reviewer for prostate, ovarian, and breast cancer research programs at the United States Department of Defense (DOD). In addition, he served as a scientific reviewer and chairman for nearly 30 years on numerous scientific committees and review panels for the NIH, including the National Cancer Institute (NCI) and the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). These roles involved evaluating nationally important medical research programs and supporting innovative biomedical research initiatives. Currently, he is an associate editor of “Clinical Cancer Research” journal.