Hepatitis C virus (HCV) is a widespread, persistent disease affecting 1- 2% of the world's population. Only a fraction of HCV affected individuals respond to interferon therapy. Viral genotype has emerged as a clinically significant predictor for determining response to interferon. This proposal describes the application of a novel DNA fingerprinting technology, Cleavase Fragment Length Polymorphism (CFLP) to identifying HCV genotype.
The specific aims of Phase II are to generate a two-pronged CFLP HCV genotyping kit for rapid identification of a broad range of HCV types and subtypes. This kit will be suitable for analysis of the highly conserved 5'NCR subgenomic region as a follow-on to widely used HCV detection systems as well as for analysis of the NS-5b region for high-resolution genotyping. Signature elements of CFLP cleavage patterns will be used to identify genotype in uncharacterized samples. The Phase II proposal includes internal validation testing and beta site testing in two prominent reference labs. The CFLP HCV genotyping kit will be capable of discriminating HCV genotype with up to 98% certainty (for single base changes, >98% for the multiple polymorphisms that form the basis of genotyping) in less time and for a lower cost than existing methods.

Proposed Commercial Applications

Genotypic identification of hepatitis C Virus (HCV) is a rapidly growing area of research and clinical practice. In addition to affecting responsiveness to interferon, HCV genotype is likely to be an important factor in the evaluation of future antiviral therapies. CFLP is a fast, accurate, and user-friendly method for HCV genotyping. By developing a two-pronged assay, we propose to create a product suitable for immediate clinical use in detecting commonly occurring genotypes (based on the 5'NCR subgenomic region) as well as a more far-reaching method for higher-resolution typing (based on the NS-5b region).

Agency
National Institute of Health (NIH)
Institute
National Institute of General Medical Sciences (NIGMS)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44GM051704-03
Application #
2734759
Study Section
Special Emphasis Panel (ZRG2-SSS-Y (15))
Project Start
1994-07-01
Project End
1999-06-30
Budget Start
1998-07-01
Budget End
1999-06-30
Support Year
3
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Third Wave Technologies, Inc.
Department
Type
DUNS #
City
Madison
State
WI
Country
United States
Zip Code
53719