Serimmune — Department of Health and Human Services SBIR Phase I: NIAID

Serimmune — SBIR Phase I award from Department of Health and Human Services.

Amount
$224,975
Agency
Department of Health and Human Services · National Institutes of Health
Program / Phase
SBIR · Phase I
Topic
NIAID
Solicitation
PA18-574
NAICS
Place of performance
CA
Period
2019-04-01 → 2019-12-31

Description

Chronic fatigue syndrome is a disabling condition formillion Americans associated withprolonged fatiguepost exertional malaiseand sleep disturbancesThe cause of CFS remainsunknownand there are currently no available diagnostic tests to confirm diseaseHoweverasubstantial number of immune features have been measured in CFSGiven this problemthe objectiveof this project is to identify a panel of distinct antibody epitopes that can be used to identifycases of CFS using a blood testIn Aimwe will apply serum epitope repertoire analysis todetermine the antibody epitope repertoires within a cohort ofCFS patients andcontrolsAntibody epitopes occurring in CFS seraand not controls will be identifiedusing bioinformatics methodsA panel of motifs will be downselected using machinelearning to optimize sensitivity and specificity within the discovery setThe performance ofthe panel will be measured in an independent set of specimens to determine sensitivity andspecificityand identify potential CFS subgroupsWe will determine whether individualmarkersor sets of markerscorrelate with various clinical features of CFSInfections with a variety of pathogens have been associated with the development of fatigue lastingone year or longerand post infection fatigue patients typically meet clinical criteria for CFSGiven the potential for heterogeneous infectious etiologywe hypothesize that CFS patients mayexhibit increased rates of seropositivity for a broad set of infectious agents associated withfatigueUsing serum epitope repertoire analysiswe will determine whether IgG seropositivity forinfectionsas a groupdiffers between CFS patients and controlsThe proposed project mayidentify antibody biomarkers suitable for development of diagnostic immunoassay for CFSand mayelucidate whether prior or ongoing infections are associated with CFS Chronic fatigue syndromeCFSalso known as myalgic encephalitisMEis a disabling conditionaffecting an estimatedmillion people in the United StatesThe cause of CFSremains unknownand there are no objective laboratory diagnostic tests toconfirm diseaseConsequentlydiagnosis of CFS remains exceptionally difficultrequiring theexclusion of a wide variety fatiguing illnessesThis project aims to apply advanced moleculardiscovery tools and computation to identify patterns of circulating antibodies that can beused to diagnose and monitor CFS patients using a blood testThis project also holds thepotential to associate prior infections with the development of CFS