Serimmune — Department of Health and Human Services SBIR Phase II: 400

Description

Lyme disease caused by Borrelia burgdorferiand other tick borne diseases cause substantialmorbidity in the USEven somany infections remain undiagnosedThoughmorethan$millionis spent annually in the US for aboutmillion Lyme serological diagnostictestsavailabletests lack desired levels of combined sensitivity and specificity and the capability to detect themany distinct tick transmitted infections that can occurThe aimofthisPhaseII project isto develop and validate a diagnostic laboratory developed testLDTthat exhibits improvedsensitivity and specificityand lower costwhen compared to current two tier testing and enablessimultaneous detection of multiple tick borne infectious organismsDigital serology is a diagnostic platform that allows for rapid development of new diagnostic testswith improved performanceand combination of an arbitrary number of tests into a single assaywithout increasing costDigital serology uses large random peptide librariesnextgenerationsequencingNGSand custom bioinformatics tools to simultaneously map the diverse spectrum ofimmunogenic antigen epitopes targeted for a given diseaseThe first Aim of this this project is to discover and optimize IgG and IgM epitopemotifdiagnostic panels highly specific to tick borne infections including Borellia burgdorferiBabesiamicrotiAnaplasma phagocytophilumand Ehrlichia chaffeensisand additional Borrelia species Bmayonii and BmiyamotoiUsing well characterized specimens for eachdiseaseinfectionspecific peptide motifs will be identified and optimized bioinformatically using motif discoverysoftware and a database ofepitope repertoires from individuals with other diseases andhealthy controlsThe second Aim of this project is to fully analytically validate panels for atleast four different infections using large validation setsReproducibilitycross reactivitypotentially interfering substancesand storage andtransportstabilitywillbedeterminedfor each testThis project is expected to result in a multiplexed test for tick borne diseases that is expandableto detect the many distinct infections that can occur from atickbiteandthat exhibitsimproved diagnostic performance and reduced cost