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HLA Chip Product for FDA 510K Approval

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
71234
Program Year/Program:
2009 / SBIR
Agency Tracking Number:
AI060166
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
GENOMICS USA, INC.
3450 S. Broadmont TUCSON, AZ 85710-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2009
Title: HLA Chip Product for FDA 510K Approval
Agency: HHS
Contract: 2R44AI060166-05
Award Amount: $2,513,348.00
 

Abstract:

DESCRIPTION (provided by applicant): We describe here a Phase II Competitive Renewal grant application, which will support a three year program of ASHI (American Society of Histocompatibility and Immunology) and FDA 510K review, for the HLA-Chip which we have developed over the past two years, with Phase II SBIR support. The deliverable at the end of year three of this Competitive Continuation will be a product platform that has been approved for very high throughput, microarray-based HLA typing, at th e DNA level, in support of ASHI and FDA validated organ and marrow transplantation. However, we argue that the product will have been delivered at a cost that is low enough and with processing throughput that is high enough, that the same clinically approv ed HLA-Chip will stand ready to support a much broader future role for HLA screening medicine: for applications such as cancer risk screening, vaccine response screening, and microbial sensitivity screening, for neonates, for the military, and for civilian adults. Thus, at a somewhat higher level of abstraction, we argue that HLA-typing via the HLA- Chip can be viewed as a generalized prototype for all of complex medical allelotyping: as foreseen in gene- based personalized medicine, gene-based in vitro dia gnostics, and gene-based public health screening. To assist in that critical and complex clinical approval process, we have obtained the collaborative support of Dr. Tony Lam, an expert in the FDA approval process, with special expertise in microarray-base d IVDs; Dr. Paul Dunn, ASHI director for the New Zealand Blood Service HLA-typing laboratory, and Dr. Kamala Balakrishnan, former Chair of the ASHI Accreditation Committee, and past President of ASHI. PUBLIC HEALTH RELEVANCE: The specific focus of this Phase II Competing Renewal is to obtain both ASHI certification (as a service offering) and FDA 510K approval for the HLA-Chip, to support generalized HLA-typing. The specific, clinically validated applications for such generalized HLA-typing in the presen t practice of medicine and public health are solid organ and bone marrow transplantation and so, to begin with, the ASHI and FDA approvals that we seek will allow the HLA-Chip to be used in those two specific contexts. However, the current understanding of vaccine risk response, as championed by our collaborators at Mayo (Dr Poland) and others, suggests that the gene content of the HLA-Chip that we will submit for review by ASHI and by the FDA (A,B,C,DRB1,DQA,DQB,DPA andDQB) will be very similar, if not identical to the HLA-Chip that will be needed to support vaccination medicine, once HLA typing has been validated as a critical component of the practice of vaccination medicine. We argue that, having obtained ASHI and FDA approval for the HLA-Chip for org an, marrow and stem cell transplantation, the necessary follow-on approvals for the HLA- Chip for vaccine treatment, will be greatly facilitated. The idea of such equivalence between transplantation and vaccination applications for the HLA-Chip has been ni cely validated in our preliminary discussions with the FDA.

Principal Investigator:

Krishna Jayaraman
8473591032
KJAYARAMAN3@GMAIL.COM

Business Contact:

Krishna Jayaraman
kjayaraman3@comcast.net
Small Business Information at Submission:

GENOMICS USA, INC.
GENOMICS USA, INC. 1041 E LOWELL ST, RM 438, BIOSCIENCES WEST TUCSON, AZ 85721

EIN/Tax ID: 175300185
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No