This is a proposal to develop a cGMP-manufactured RNA labeling kit suitable for clinical diagnostic assays and research applications that require multiplex RNA detection. The kit's target preparation technology will enable accurate and reproducible profiling of total RNA, including both microRNA (miRNA) and mRNA transcripts when combined with compatible microarray platforms. In contrast to conventional labeling methods, this RNA labeling method provides an innovative approach to the analysis of clinical samples with compromised RNA such as biofluids and formalin-fixed, paraffinembedded (FFPE) tissues. A kit that provides clinical researchers access to accurate and comprehensive expression profiles from FFPE tissues is likely to accelerate the identification and development of RNA biomarkers with clinical utility for cancer diagnosis and prognosis. Furthermore, because the direct, end-labeling procedure is simpler and faster than commercially available target preparation kits for arrays, it should be readily integrated into a streamlined diagnostic format for clinical laboratories. Phase I will optimize and the labeling method for RNA from FFPE tissues and evaluate its performance prior to entering the development cycle required for cGMP manufacturing guidelines that will make the kit suitable for implementation into clinical diagnostic laboratories.
This improved method for labeling RNA will provide for a robust, reliable and accurate kit that will enable the analysis of important clinical samples and will be integrated into emerging clinical assays to support patient care and clinical management of disease. ? ? ?
