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