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SCREENING PRETEST FOR HEREDITARY COLON CANCER (HNPCC)

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
53743
Program Year/Program:
2001 / SBIR
Agency Tracking Number:
1R43CA090122-01
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
CA*TX, INC.
1110 TURNER BLVD OMAHA, NE 68105
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2001
Title: SCREENING PRETEST FOR HEREDITARY COLON CANCER (HNPCC)
Agency: HHS
Contract: N/A
Award Amount: $121,545.00
 

Abstract:

DESCRIPTION: Our goal is to develop a diagnostic assay to identify carriers of the hereditary colon cancer (HNPCC) trait using blood samples as the input specimen. In Phase 1 we will demonstrate the assay's feasibility, showing: 1) requisite predictive value, 2) practicality (easy, rapid, inexpensive), and 3) adaptability to automated technologies. Our assay should detect cellular changes in DNA mismatch repair (MMR) genes (MLH1 & MSH2), changes that occur in HNPCC individuals due to mutation of one of the two alleles of the MLH1 or MSH2 gene. We already demonstrated plausibility for this strategy in preliminary models in which the assay outcome correlated with wild-type gene status. Our AIMS are: 1) to develop a predictive assay for MMR mutations that 1a) accurately demonstrates that the assay outcome correlates with genotype; 1b) distinguishes between cells homozygous and those heterozygous for the wild-type allele and between individuals with and without the HNPCC trait; 2) to adapt our assay to work with automated systems. This will lead to our Phase 2 objective: to integrate our assay into quantitative, commercial, automated systems. PROPOSED COMMERCIAL APPLICATION: The commercial application of our assay involves a practical test for hereditary nonpolyposis colon cancer (HNPCC) affecting over 5 million people in the western world. Detecting HNPCC before cancer develops offers a clinical benefit since cancer prevention strategies reduce their mortality. If technically feasible (Phase 1), the likelihood of our assay becoming commercialized (Phase 2) is outsanding because of the strong commitment of this project by Bayer Diagnostics, which nationally distributes automated diagnostic systems.

Principal Investigator:

Zhiping Gao

Business Contact:


4023454842
CATXINC@AOL.COM
Small Business Information at Submission:

CA*TX, INC.
1110 TURNER BLVD OMAHA, NE 68105

EIN/Tax ID: 470770661
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No