SBIR Phase II: Biomolecular Detection of microRNA

This Small Business Innovation Research Phase II project examines high throughput methods to quantify intacellular microRNA (miRNA) concentrations in cells that have shown to be associated with normal physiological processes, as well as diseases, including cancer. Currently there are no rapid, quantitative methods available to measure miRNA expression in living cells or tumor tissue. All current in vitro approaches require extensive preparation involving extraction, reverse transcription of miRNA into cDNA and amplification. These methods are not only time consuming, but require that the low abundance miRNA be several fold greater than background to give a meaningful result. To meet the demand for a diagnostic/prognostic tool, development of a biomolecular detection device is proposed based on a single electron transistor to bind and measure the concentration of miRNAs. This will provide a researcher or clinician an accurate profile to make proper clinical assessments. Bringing this device to market will provide scientists with direct information on intracellular miRNA levels, enhancing predictions of miRNAs that are essential for tumor maintenance or metastasis, and creating new diagnostic and therapeutic opportunities. The broader impact of this project will be to enhance current diagnostic and prognostic tools for early detection of disease. Today, early cancer detection and treatment offers the best outcome for patients. This has driven the search for effective diagnostics. The identification of a universal tumor specific epitope or marker has remained elusive. While many types of serological and serum markers have included enzymes, proteins, hormones, mucin, and blood group substances, at this time there are no effective diagnostic tests for cancer that are highly specific, sensitive, economical and rapid. This deficiency means that many cases of malignancy go undetected long past the time of effective treatment. The goal of this research is to bring a device to market for the research market and a device that can examine miRNA profiles from patient samples immediately in a hospital or clinical setting. The current size of the in vitro diagnostic market was over $40 billion in 2008. Unique diagnostic kits developed from this technology will likely fulfill an unmet market opportunity with the potential to exceed $100 million in the first 3 - 5 years.