Abstract:
Precision oncology is transforming cancer management by integrating molecular profiling with clinical information to enable early detection, accurate diagnosis, personalized treatment, and improved patient outcomes. Genomic testing identifies cancer-associated molecular alterations, supports prognostic assessment, and guides targeted therapies and immunotherapies. Emerging RNA-based therapeutics and gene therapies offer additional opportunities to selectively target cancer-associated pathways and enhance antitumor immune responses. To advance these objectives, we have developed a novel, noninvasive, plasma cell-free mRNA–based genomic platform for cancer detection, diagnosis, and molecular risk stratification. In a multicenter study involving 500 prostate cancer samples and 150 normal samples collected across nine hospitals, a 25-gene blood-based assay demonstrated excellent diagnostic performance, achieving an AUC of 0.906, 90% sensitivity, and 91% specificity. Tissue-based analysis demonstrated comparable performance (AUC 0.9514, 95% sensitivity, and 94% specificity). Higher gene-expression scores were associated with Gleason scores greater than 7, suggesting potential utility for assessing tumor aggressiveness and prognostic risk. Subsequent prospective clinical evaluation further supported the diagnostic potential of GeneVerify for prostate cancer detection, demonstrating promising agreement with biopsy-based diagnosis. Additional clinical studies in kidney, breast, and bladder cancers have shown encouraging diagnostic performance, supporting the broader applicability of this molecular platform. GeneVerify's blood-based technology offers the potential for rapid, minimally invasive cancer detection, improved molecular risk stratification, and more informed clinical decision-making, potentially reducing unnecessary invasive diagnostic procedures following further clinical validation. In parallel, advances in RNA-based cancer vaccines, gene-silencing technologies, and targeted RNA therapeutics are creating new opportunities for precision cancer treatment. Several RNA-based therapeutic approaches are undergoing clinical investigation, although their eventual regulatory approval will depend on demonstrated safety and efficacy. Together, these innovations represent a promising shift toward integrated precision oncology—combining molecular diagnostics with personalized RNA-based therapeutics to improve cancer detection, guide treatment selection, and ultimately enhance patient survival and quality of life.
