Proteomics-based Diagnosis and Management of RA

DESCRIPTION (provided by applicant): Treatment of rheumatoid arthritis (RA) has improved dramatically with the advent of the biological DMARDs (etanercept, infliximab, adalimumab and anakinra) and additional interventions with the potential of substantially altering the prognosis of this disease are in advanced clinical development. Unfortunately, the ability to diagnosis and manage early RA, before significant and potentially irreversible bone and joint damage has already occurred, still remains a challenge. SomaLogic is committed to the improvement of the management of RA as well as other inflammatory and immune-mediated conditions by the application of its proprietary aptamer and photoaptmer technology for better and earlier diagnosis of disease as well as the ability to monitor therapeutic response to new interventions quickly and unambiguously. The specific aims of the proposed research are to: 1) Develop photoaptamers to a minimum of 10 protein targets associated with RA that are not already in the menu of proteins for which photoaptamers exist using proprietary SELEX protocols incorporating standard and modified nucleotide libraries; 2) Analyze archived serum samples from patients with RA and various control populations using current and future SomaLogic microarray-based proteomic assays incorporating photoaptamers developed to the proteins identified; and, 3) Identify biomarkers and candidate bioinformatics-based algorithms (signatures) for the use in the diagnosis and management of patients with RA. Successful completion of Phase I will allow SomaLogic to initiate the more formal development of an in vitro diagnostic capable of providing the clinician with greater information for the diagnosis and management of RA. To commercialize such a product, we intend to market our diagnostic products and services in at least two formats: 1) A fee-for-service CLIA approved laboratory test that clinicians can use by sending patient samples to SomaLogic for analysis and / or, 2) an on-site laboratory diagnostic sold to hospital or commercial laboratories by SomaLogic.