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Screening Test for HPV+ Head and Neck Cancer

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
95719
Program Year/Program:
2010 / SBIR
Agency Tracking Number:
AI082815
Solicitation Year:
N/A
Solicitation Topic Code:
NIAID
Solicitation Number:
N/A
Small Business Information
HIGH THROUGHPUT GENOMICS, INC.
3430 E. Global Loop TUCSON, AZ 85706-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2010
Title: Screening Test for HPV+ Head and Neck Cancer
Agency: HHS
Contract: 1R43AI082815-01A1
Award Amount: $600,000.00
 

Abstract:

DESCRIPTION (provided by applicant): There is currently no good way to screen for early stages of head and neck cancers caused by high risk types of human papillomavirus. The objective of this proposal is to develop a screening assay for dental patients to detect HPV+ head and neck cancer ( HNC ) pre-symptomatically, based on the use of viral and host gene biomarkers. The overall hypothesis of this proposal is that as the development of HPV-associated HNCs proceeds, a number of viral and cellular events occ ur that can be exploited as biomarkers. This combination of biomarkers creates a molecular signature for cells transformed by HPV and consequently could be used to identify individuals likely to develop cancer. More broadly, the same is true of HNC not ass ociated with HPV infection. Furthermore, we propose that, due to the anatomical location of these tumors, the probability that cells from these cancers can be found in saliva in sufficient numbers for the detection of these biomarkers is high, though anoth er accessible fluid for screening would be blood. Evidence for this hypothesis has been published. We will begin by profiling the gene expression changes associated with HPV+ and HPV- HNC using a new assay on a high density array platform, the qNPA assay. In this assay, we will validate genes implicated by previous studies as putative biomarkers, and also test viral DNA and mRNA coding for genes associated with HPV, additional genes that cover cellular pathways and receptors, and miRNA. We will use tissue samples and matched blood and saliva samples to identify those candidate biomarkers that can be found (ideally) in saliva and that have the potential to distinguish between HPV-associated HNC, HNC not associated with HPV, and controls. The overall goal of this proposal is to develop a rapid, accurate and cost- effective diagnostic tool for the early identification of pre-cancerous and cancerous lesions in the head and neck area, using saliva as a sample source, with Phase I SBIR being the identification of signature genes using high-density array measurements. It is the objective of this program that the ultimate diagnostic test panel developed in a follow-on Phase II will be performed by reference laboratories on samples collected in dental offices as part of routine patient assessments to identify HPV infection and HNC. Phase I will identify putative DNA, mRNA and miRNA biomarkers for use in the diagnosis of oral HPV and the early diagnosis of HPV+ HNC. It is anticipated that, based on these results, a focu sed diagnostic array test (or tests) can be designed for the low-cost ArrayPlate microplate platform (Phase I, Aim 4) to be developed and validated in a Phase II grant application, which will also fund the testing of samples of an accessible fluid (expecte d to be saliva, but alternatively blood) from a large number of dental patients. It is anticipated that this overall program will result in validated diagnostic tests for: i) oral HPV; ii) HPV+ HNC; iii) HPV- HNC; and for iv) the pre- symptomatic identific ation of HNC. PUBLIC HEALTH RELEVANCE: At this time, there is no good way to screen for head and neck cancers ( HNC ) that are caused by Human Papillomaviruses (HPV). We propose that as the virus infects these cells and cancer begins to develop, cha nges in the mRNA and miRNA expressed in the affected cells occur that can be detected and used as biomarkers for the development of cancer, and further, that these can be detected in easily-accessible material, such as blood or saliva. This proposal is d esigned to develop a panel of biomarkers that could be detected in saliva, thus making it much easier to identify those individuals who are developing or are at risk for developing HNCs, especially those associated with HPV. The goal is to make it possible to quickly and accurately detect early stage HPV-associated HNC in individuals during routine dental visits.

Principal Investigator:

Bruce E. Seligmann
5205472828
BSELIGMANN@HTGENOMICS.COM

Business Contact:

Constance Junghans
cjunghans@htgenomics.com
Small Business Information at Submission:

HIGH THROUGHPUT GENOMICS, INC.
3430 E. Global Loop TUCSON, AZ -

EIN/Tax ID: 186091229
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No