AFFINERGY, LLC — Department of Health and Human Services SBIR Phase I: NIAID

Description

SUMMARY ABSTRACT At leastautoimmune diseasesADshave been identified to dateaffecting more thanmillion AmericansFor the majority of ADsthere is no clear method of diagnosisEarly intervention is key to controlling the progression of diseasethus delays in diagnosis lead to higher disease burdens for patients and increased costs for treatmentCurrent diagnostic methods are complexnon standardized and frequently inconclusiveSystemic sclerosisSScis one of the most disabling autoimmune rheumatic disordersSSc is a rare diseaseaffecting betweentopeople in the United Statesand is three to four times more common in women than menUncertainty in prevalence derives from the complexity of a disease characterized by both organ specific and systemic manifestationsIt is a multisystem disease characterized by widespread vascular dysfunction and progressive fibrosis of the skin and internal organsand diagnosis most often occurs only after significant and irreversible tissue and organ damageThusthere is an urgent unmet need to develop a simplerapid test that can lead to early diagnosis of systemic sclerosisADs are characterized by loss of self tolerance by the immune system and the production of abnormal levels of autoantibodiesThese autoantibodieswhether pathological or notare the serological markers of autoimmunityIt is now clear that the heterogenous and overlapping nature of AD makes it unlikely that any single autoantibody will be unique and diagnostic for a particular diseaseA promising approach for developing new diagnostics therefore relies on the identification of an autoantibodysignaturethatwhen taken togethercould unambiguously diagnose a particular diseaseWe propose to screen random peptides to develop a novelmultiplex peptide array that can be used by any clinical laboratory to diagnose systemic sclerosisThe use of random peptides ensures that we are unconstrained by pre existing knowledge about which antibodies are enriched or significant in SScOur technology will only require that a signature group of antibodies is reproducibly present in the blood of SSc patientsbut not in healthy patients or those with other ADsPhage display biopanning of SSc patient immunoglobulin using a random peptide library followed by next generation sequencing will be unbiased and exhaustiveWe are not concerned with the identity of antigens or autoantibodieswe are instead focused on identifying a unique peptide signature that can be used to unambiguously diagnose SScOur peptide based diagnostic array will be familiar to end users in clinical labs and will significantly shorten the time to diagnosisallowing for immediate treatment and monitoring PROJECT NARRATIVE Autoimmune diseases are challenging to diagnose and delays in diagnosis and treatment lead to increased disease burden and additional stress on the patientwhile lack of clear diagnostic criteria impedes clinical trialsSystemic sclerosis is one of the most debilitating systemic autoimmune disordersand given the devastating manifestations of this diseaseit is critical to make an early and definite diagnosis to initiate timely therapy and prevent misdiagnosisAffinergy is developing a novel diagnostic assay to unambiguously diagnose systemic sclerosis using a small amount of patient serum