GENETIC DIAGNOSTIC TEST FOR ESSENTIAL HYPERTENSION

Award Information
Agency:
Department of Health and Human Services
Branch:
N/A
Amount:
$153,537.00
Award Year:
2004
Program:
STTR
Phase:
Phase I
Contract:
1R41HL074526-01
Agency Tracking Number:
HL074526
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
HYPOGEN, INC.
HYPOGEN, INC., BOX 3608, CHARLOTTESVILLE, VA, 22903
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
N
Duns:
N/A
Principal Investigator
 ROBIN FELDER
 (434) 924-5151
 RAF7K@VIRGINIA.EDU
Business Contact
 AARON HULLMAN
Phone: (434) 245-9552
Research Institution
 UNIVERSITY OF VIRGINIA
 UNIVERSITY OF VIRGINIA
Virginia, VA, 22904
 Nonprofit college or university
Abstract
DESCRIPTION (provided by applicant): Essential hypertension, or elevated blood pressure of unknown etiology, is responsible for more morbidity and mortality than the top five leading diseases. However, no diagnostic test exists for the prediction of essential hypertension. We have developed a human diagnostic test based on 4 single nucleotide polymorphisms (SNPs) that will successfully predict the hypertensive phenotype approximately 70 percent of the time (1) in Ghanaians, and 92 percent of the time in Japanese (2). Our studies have been conducted in several ethnic populations such as Ghanaians (n = 80), Japanese (n = 800), and Italian Caucasians (n = 120). We have a patent pending on three of the diagnostic SNPs found in the G protein related kinase type 4 (GRK4) (3). We have successfully sublicensed access to a key fourth SNP in the angiotensin converting enzyme (ACE) gene. This hypertension predicting genetic profile, called the "Hypogen Test," can be easily and affordably measured using our published method (4) employing the Amplifluor TM technology using a conventional thermal cycler followed by a closed tube fluorescent endpoint. Our specific aims are focused on: 1). improving the predictive capability of diagnostic test by broadening the SNP profile, by testing additional SNPs associated with essential hypertension in our previously tested cohorts, and: 2) expanding the potential use of the test by testing a recently acquired Chinese cohort (N=800). We also plan on transitioning the Hypogen Test from the research laboratory to a clinical laboratory certified by the clinical laboratory improvement act of 1988 (CLIA) to perform molecular diagnostic testing so that patient specimens may be analyzed

* information listed above is at the time of submission.

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