HLA Chip Product for FDA 510K Approval

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$2,798,132.00
Award Year:
2006
Program:
SBIR
Phase:
Phase II
Contract:
2R44AI060166-02
Award Id:
71234
Agency Tracking Number:
AI060166
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
GENOMICS USA, INC., 1041 E LOWELL ST, RM 438, BIOSCIENCES WEST, TUCSON, AZ, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
141832860
Principal Investigator:
KRISHNAJAYARAMAN
(847) 359-1032
KJAYARAMAN3@GMAIL.COM
Business Contact:
KRISHNAJAYARAMAN
(847) 477-4715
kjayaraman3@comcast.net
Research Institute:
n/a
Abstract

DESCRIPTION (provided by applicant): Current technology for HLA typing does not have rapid field response capability because it too expensive and is too complicated to be implemented in the context of a population-scale emergency. The ultimate goal of this proposal is to develop a simple, accurate, low cost method to perform complex HLA typing through development of an "HLA Chip" which will enable population-scale analysis of a large set of the most important HLA alleles. Genomics USA (GUSA) has developed a unique "self-assembling" microarray technology and bioinformatics to enable the mass production of medium density microarrays at very low cost. In Phase I of this SBIR, the following major objectives were accomplished: 1) An enabling variant of the original self-assembling GUSA microarray platform was discovered which allows high sequence specificity and a 10-fold increase in hybridization signal relative to the technology described in the original application. The observed result of this major improvement is direct, biochemically-unaided SNP detection with the simplicity, accuracy and reproducibility required for low cost, population scale HLA typing. 2) Bioinformatics tools were developed to create large sets of SNP- selective hybridization probes that are consistent with the physical requirements imposed by "self- assembling" attachment of probes to the microarray surface and 3) It was demonstrated that a buccal swab is an excellent source of DNA for miniaturized HLA typing on the HLA Chip and a simple approach to collect buccal swabs in the field and to store them for centralized HLA processing in the dry state was also developed. In Phase II of this SBIR, the HLA Chip development process will be extended to the entire HLA locus and validated as a beta field test to document accurate HLA genotyping at a rate of 1000 individuals per day per portable laboratory site. The beta test will demonstrate, via, simple extrapolation, the ability to HLA type a large exposed population (100,000 individuals per week) using as few as 10 low cost, portable field laboratories. Such HLA data could then be used in "real time" to anticipate, at the HLA level, individual risk of infection by a biological weapon or personalized response to vaccination against the same infectious agent. Variants of this low cost, portable HLA Chip technology could be "spun off" for a variety of other applications: civilian ID in a disaster or personalized medicine, especially for autoimmune diseases. Those other applications are technically similar, but will be explored and funded independently. The project focus is the development of a low-cost population-scale HLA Chip technology that can be implemented in a rapid-response environment that would allow rapid HLA typing of a large exposed population (100,000 individuals per week) in order to identify high risk individuals and to predict, on an individual level, their personalized response to vaccination.

* information listed above is at the time of submission.

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