The demand for robust, reliable, and minimally invasive diagnostic technologies represents a pressing need in the early detection, stratification, and surveillance of aggressive cancers. Cell-free microRNAs (miRNAs) represent a novel class of biomarkers that have shown promise during initial studies and may have significant clinical utility. The ability to efficiently and accurately identify and quantify circulating miRNA populatins is challenging however, and current approaches fail to meet the requirements of high specificity, sensitivity, accessibility, and reproducibility necessary for widespread adoption in screening and monitoring applications. In this phase I SBIR application, RedVault Biosciences proposes to establish the feasibility of a novel multiplex diagnostic platform to characterize circulating cell free miRNA populations, specifically those miRNAs of immediate utility in pancreatic cancer diagnosis, stratification, and intervention. The broadly-enabling technology leverages novel advancements in advanced molecular genomics, synthetic biology, and digital nucleic acid analysis to significantly reduce current, complex laboratory workflows and provide quantitative, reproducible and clinically informative results. Successful development of this technology could provide fundamental information to positively affect miRNA research, disease management, and patient survival.
Public Health Relevance Statement: Public Health Relevance: Leveraging advanced molecular genomics technology and novel nucleic-acid detection methods, RedVault Biosciences' proposes an innovative approach to reliably interrogate plasma specimens for clinically relevant miRNAs. The methodology is a robust, rapid, specific, sensitive and cost-effective solution that meets the stringent criteria lad out for effective diagnostic platforms. Successful development of this technology may deliver a fundamental advancement in the cancer screening, tumor surveillance, and miRNA research fields.
NIH Spending Category: Bioengineering; Biotechnology; Cancer; Digestive Diseases; Nanotechnology; Pancreatic Cancer; Prevention; Rare Diseases
Project Terms: Adoption; Affect; Automation; base; Biological Assay; Biological Markers; Biological Sciences; Blood Plasma Volume; Cancer Detection; cancer diagnosis; Cells; circulating microRNA; Clinical; clinically relevant; college; Complex; cost; cost effective; Data; density; design and construction; Detection; Development; Development Plans; Devices; Diagnostic; digital; Disease Management; DNA Structure; Early Diagnosis; Feasibility Studies; Genomics; Goals; Imaging technology; innovation; Intervention; Laboratories; Lead; Letters; Libraries; Malignant neoplasm of pancreas; Malignant Neoplasms; Mediating; medical schools; Medicine; meetings; Methodology; Methods; MicroRNAs; minimally invasive; Molecular; Monitor; multiplex detection; Nanosphere; Nature; new technology; novel; nucleic acid detection; Nucleic Acids; Patients; Pattern; Phase; Physiologic pulse; Plasma; Population; Preparation; Process; public health relevance; Reporter; Reproducibility; Research; Sampling; screening; Screening for cancer; Sensitivity and Specificity; single molecule; Small Business Innovation Research Grant; Specimen; Stratification; synthetic biology; Techniques; Technology; technology development; Testing; Time; Tube; tumor; Validation
