Seriodiagnostic arrays for biodefense and emerging infectious diseases

DESCRIPTION (provided by applicant): In Phase I of this SBIR, ImmPORT Therapeutics and the UCI Proteomics Core developed a high throughput gene cloning and protein expression platform that allowed the proteomes of any sequenced infectious agent to be expre ssed and printed onto microarray chips. Since Phase I we have cloned and expressed ~15,000 genes from nearly 20 different pathogens associated with biodefense and emerging infectious diseases. By probing the arrays with sera from individuals with well-defi ned clinical stages of infection, we have built up a vast dataset concerning which antibodies are present in different stages of disease. By using statistical and bioinformatic algorithms, we can derive antigen sets that, when combined, can provide the bas is for serological tests able to discriminate between different infections, or even between different stages of the same infection. Phase II, ImmPORT will establish a GMP manufacturing facility and a Clinical Research Lab to offer diagnostic products and s ervices to developers of novel vaccines, physicians and Phama. At the head of a product pipeline will be serodiagnostic immunostrips that will be evaluated for discriminating orthopoxvirus infections from clinically similar rash infections and for diagnosi ng TORCH infections associated with problems during pregnancy. Aim 1: Clone an additional 2000 genes from various rash causing organisms and combine these with an existing inventory of orthopoxvirus and herpes viruses. These will printed on arrays and, in collaboration with colleagues at the CDC, arrays will be probed with well characterized sera to define immunodominant and serodiagnostic antigens. From these data we will produce prototype immunostrips for manufacture and evaluation at CDC. Aim 2: Establis h a GMP protein purification and diagnostic reagent manufacturing facility at ImmPORT. The facility will manufacture protein arrays and immunostrips for its Clinical Research Laboratory , and assay kits that will be sold to biomedical research labs and ref erence laboratories, and as a pivotal FDA-required assay to support licensure of clinical products. Aim 3. Establish a Clinical Research Laboratory at ImmPORT to offer serodiagnostic testing services that will operate in compliance with the Clinical Labora tory Improvement Amendment (CLIA) to be certified to perform validated testing on human specimens for diagnosis, and to provide FDA compliant test results to support licensure of clinical products. With the establishment of a manufacturing infrastructure a t ImmPORT, the company's high throughput antigen discovery platform will continue to rapidly identify candidate antigens for development of other serodiagnostics and subunit vaccine products for category A, B and C biological agents and well as other emerg ing infectious diseases of importance to human health. Project Narrative With support from a phase I SBIR, ImmPORT Therapeutics and the Proteomics Core Lab UCI developed a method for screening the whole proteomes of infectious organisms for diagnostic and vaccine antigens. In Phase II, ImmPORT will establish a GMP manufacturing facility and a Clinical Research Lab to offer diagnostic products and services to developers of novel vaccines, physicians and Phama. At the head of a product pipeline will be serodi agnostic immunostrips that will be evaluated for discriminating orthopoxvirus infections from clinically similar rash infections and for diagnosing TORCH infections associated with problems during pregnancy. PUBLIC HEALTH RELEVANCE With support from a phas e I SBIR, ImmPORT Therapeutics and the Proteomics Core Lab UCI developed a method for screening the whole proteomes of infectious organisms for diagnostic and vaccine antigens. In Phase II, ImmPORT will establish a GMP manufacturing facility and a Clinical Research Lab to offer diagnostic products and services to developers of novel vaccines, physicians and Phama. At the head of a product pipeline will be ser