SBIR-STTR Award

Human disease is a consequence of both genetic susceptibility and environmental exposure. The capability of rapidly scanning a large gene in a large number of samples for the presence and location of all heterozygous mutations and gene variations can result in critical improvements in health care. To achieve this AndCare will develop the method proved feasible in Phase I into a new diagnostic product for the rapid, quantitative, electrochemical detection of altered nucleic acid sequences. In Phase II AndCare will exploit innovative methodology to electrochemically detect inherent differences in melting temperatures of homologous and mismatched DNA annealed to an array of specific probes of wild-type sequence. In this way specific heterozygous and homozygous mutations present in a given patient sample are detected. The expected result is an assay capable of detecting point mutations as well as small insertion or deletion mutations. The technology is well suited for automation and high-throughput genetic diagnostics in clinical and research laboratories. Dr. Henkens and his staff have pioneered the use of screen-printed, disposable, amperometric sensors using colloidal gold electrodes for use with electrochemical monitors. This technology is the platform that will be used in this project.PROPOSED COMMERCIAL APPLICATION: Tools developed in this project provide new opportunities to understand the genetic basis for individual differences in susceptibility to disease. We believe that the capability of rapidly testing a large gene in a large number of samples for the presence and location of all heterozygous mutations and gene variations has important commercial applications in research and clinical laboratories.

Thesaurus Terms:
biomedical equipment development, consumable /disposable biomedical equipment, diagnosis design /evaluation, diagnostic test, electrochemistry, gene mutation, method development, nucleic acid sequence biotechnology, brca gene, clinical biomedical equipment, electrode, genetic disorder diagnosis, genetic polymorphism, genetic susceptibility, genome, nucleic acid hybridization, nucleic acid probe, point mutation, thermometry, thermostability bioengineering /biomedical engineering, human genetic material tag, human tissueNATIONAL CANCER INSTITUTE

Millions of Americans are infected by the hepatitis B virus (HBV)-many of whom have no reason to believe they are infected. There is a need to track down America's millions of HBV victims-as well as a corresponding need for innovative technology to test blood for HBV. HBV is clearly a national medical priority. The overall goal of this project is to further develop and then integrate core sensor and enzyme immunoassay technologies into a novel technique for the rapid and accurate measurement of HBV levels in blood. We are targeting diagnostic (detection) applications as well as quantitative measurement needs (to monitor viral levels and treatment efficacy). The feasibility of our approach was clearly demonstrated during Phase I. The Phase II goal is to demonstrate/validate/optimize the integration of a unique electrochemical measurement method with proprietary electrochemical enzyme immunoassay architecture to produce a new diagnostic/monitoring capability for "real time," cost-effective HBV assessment in an outpatient setting. The product we envision is a disposable HBV test strip that can be read by an inexpensive, small (hand-held) instrument. It would represent a key development in medical diagnostics that would address major domestic and international market needs for low-cost HBV screening and monitoring.

Thesaurus Terms:
biomedical equipment development, communicable disease diagnosis, diagnosis design /evaluation, electrochemistry, enzyme linked immunosorbent assay, hepatitis B virus group, serology /serodiagnosis binding protein, biotin, diagnostic test, electrode, technology /technique development human subject