HLA Chip Product for FDA 510K Approval

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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 the 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 approved 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 diagnostics, 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-based 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 present 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 &DQB) 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 organ, 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 & vaccination applications for the HLA-Chip has been nicely validated in our preliminary discussions with the FDA.