Streamlined labeling of degraded RNA for expression arrays
Department of Health and Human Services
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Small Business Information
AMBION DIAGNOSTICS, INC.
Asuragen, Inc., 2150 WOODWARD ST, AUSTIN, TX, 78744
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): 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 en able 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 ap proach 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 li kely 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 k its 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 req uired for cGMP manufacturing guidelines that will make the kit suitable for implementation into clinical diagnostic laboratories. PUBLIC HEALTH RELEVANCE: This improved method for labeling RNA will provide for a robust, reliable and accurate kit that wil l enable the analysis of important clinical samples and will be integrated into emerging clinical assays to support patient care and clinical management of disease.
* information listed above is at the time of submission.