Invasive carcinoma of the cervix is-one of the most common cancers in the world. Human papillomavirus (HPV), progressing through cervical intraepithelial neoplasia (CIN), is the primary causal agent for the development of invasive cervical cancer. However, of the 70 or more HPV subtypes, few progress to cancer. Although early detection coupled with eradication of cervical cancer precursors has been shown to lead to a decreased incidence of invasive cervical cancer, the present state of the art employs diagnostic techniques that are too costly or too time consuming to screen large populations efficiently. Accurate strain identification is presently only possible through cumbersome DNA hybridization analyses utilizing either Southern blot technology or in situ hybridization technology. In the following proposal, an enzyme-assisted, sequence- specific identification system will be developed. The simple, rapid, sensitive, accurate, and low-cost DNA diagnostic system described herein will detect HPV at very early stages of infection and will distinguish between low-oncogenic-risk strains and high-oncogenic-risk strains. This will enable large scale screening by establishing a diagnostic protocol that is sensitive, rapid, simple, and relatively inexpensive. The diagnostic tool described by this proposal is applicable in detection of other infectious diseases and genetic diseases with only simple modifications.

Proposed Commercial Applications

The proposal describes a rapid and inexpensive DNA diagnostic tool suitable for routine used which matches the specificity, accuracy and sensitivity of hybridization or PCR-based assays. In addition to the screening of HPV, the diagnostic tool described by this proposal is applicable in the detection of other infectious diseases and genetic diseases with only simple modification.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44CA075771-02A1
Application #
6143917
Study Section
Special Emphasis Panel (ZRG1-SSS-Y (01))
Program Officer
Hall, Leota
Project Start
1998-04-01
Project End
2002-03-31
Budget Start
2000-04-15
Budget End
2001-03-31
Support Year
2
Fiscal Year
2000
Total Cost
$402,662
Indirect Cost
Name
Profile Diagnostic Sciences, Inc.
Department
Type
DUNS #
City
New York
State
NY
Country
United States
Zip Code
10016