Protein Microarray System for Rheumatiod Arthritis Diagnosis

DESCRIPTION (provided by applicant): The diagnosis of rheumatoid arthritis (RA) and other autoimmune disease is a complex challenge that combines the interpretation of a range of physiological cues and molecular assays. Traditionally, radiography has been used to measure RA progression. In vitro diagnostic tests for RA and related diseases consist almost exclusively of single marker tests. There is a well-recognized but unmet need for improved diagnostics based on biological markers to characterize disease type, status, progression, and response to therapy in autoimmune diseases. We are proposing to develop an integrated bioanalytical platform and a clinical research program to facilitate comprehensive differential phenotyping of patient samples on the basis of parallel detection of multiple biomarkers, which when interpreted as a pattern will result in highly predictive and accurate assays. The holistic clinical picture obtained from this advanced protein molecular diagnostic approach will provide the clinician with a powerful tool for early detection, classification, and prognosis, assessment of therapy and monitoring of recurrence, in the treatment of autoimmune disease. This, in turn, should lead to improved patient care, better outcomes and reduced patient care costs. The proposed system will consist of three key elements: an instrument, a protein chip microarray cartridge, and pattern recognition software for analysis. Highly parallel detection of the targeted protein biomarkers is based on an advanced label-free detection technology that we refer to as Grating-Coupled Surface Plasmon Resonance Imaging (GCSPRI). This chip-based technology makes it possible to cost-effectively measure hundreds of analytes simultaneously in near-real time in minute sample volumes (~5 - 50 fL). The long-term goal (at the end of Phase II) is to have developed the necessary foundation to be able to proceed expeditiously with FDA approval. The more limited goals of the Phase I (two years) are to develop an integrated prototype bioanalytical diagnostic platform consisting of an instrument and reagent cartridge and to develop and validate a chip designed to assay the presence of relevant analytes in human samples. The platform developed in Phase I would be used in Phase II for human clinical studies. 7. Project Narrative The proposed research aims to develop improved diagnostic methods for rheumatoid arthritis and other autoimmune diseases which affect over 50 million Americans and are a leading cause of death and disability. Anticipated products are expected to improve treatment, reduce morbidity and improve the quality of life of patients suffering from these diseases.