SBIR-STTR Award

This proposal is based on development of a novel analytical assay to detect single nucleotide polymorphisms (SNPs). The investigators propose the use of peptide nucleic acid (PNA)-oligonucleotides as probes, due to their advantages in hybridization kinetics and affinity-capture techniques. The investigators plan to detect target sequences complementary to the PNA probe with an anti- fluorescein Ab-HRP conjugate, using colloidal gold sensors to detect the byproduct of the HRP-catalyzed reaction as a change in current. The proposed instrumentation and assay may provide the basis for developing a high-throughput, automated and economical method of identifying SNPs. PROPOSED COMMERCIAL APPLICATION: The new SNP scoring system proposed here is founded on a versatile, automated chip-based system for probe analysis of DNA or RNA. It will serve as a companion instrument to PCR as a new tool for nucleic acid analysis. The laboratory market for PCR is currently $300 million per year. Our PCR-related system would represent a significant new, complementary product in this marketplace. Furthermore, as the clinical market matures, we anticipate a range of diagnostic applications that will increase the market for the instrument.

Thesaurus Terms:
biomedical equipment development, genetic polymorphism, nucleic acid probe, nucleic acid sequence, technology /technique development genetic mapping, nucleic acid hybridization, oligonucleotide human genetic material tag

Identifying the roles of variable individual genetic factors can revolutionize approaches to the diagnosis, treatment, and prevention of human disease. Single nucleotide polymorphisms (SNPs) are the most frequent DNA sequence variations that affect human health, and better methods for scoring known SNPs in the human population are needed. This SBIR project is designed to develop a sensitive, high-throughput, efficient and affordable method of scoring known SNPs. Phase I work and subsequent interim efforts have clearly established the feasibility of our approach. The overall project goal is to develop an advanced electrochemical, peptide nucleic acid (PNA) probe-based array system that can rapidly and reliably measure SNPs. The electrochemical arrays will be developed within the standard microtiter plate format, allowing researchers the ability to adapt their existing automation instrumentation to this more-efficient electrochemical platform. This expanded, 3-year Phase II project will lead to 1) development of specific PNA-based electrochemical sensor assays for the identification/quantification of known SNP sequences; 2) design/fabrication of innovative sensor arrays and appropriate array-reader instrumentation for high-throughput, accurate, easy-to-use, and inexpensive SNPs scoring in human genomic samples; and 3) demonstration, through collaborative studies, of the utility of this approach to SNPs scoring for use by researchers and clinicians. PROPOSED COMMERCIAL APPLICATION: The new SNP scoring system proposed here is rounded on a versatile, automated chip-based system for probe analysis of DNA or RNA. It will serve as a companion instrument to PCR as well as a new tool for direct nucleic acid analysis. The laboratory market for PCR is currently $300 million per year. Our PCR related system would represent a significant new, complementary product in this marketplace. Furthermore, as the clinical market matures, we anticipate a range of diagnostic applications that will increase the opportunities for the instrument.

Thesaurus Terms:
biomedical equipment development, electrochemistry, genetic polymorphism, nucleic acid probe, nucleic acid sequence, peptide nucleic acid, technology /technique development genetic mapping, microarray technology, nucleic acid hybridization, oligonucleotide human genetic material tag, human tissue