SBIR/STTR Award attributes
This proposal focuses on the development of a sample sparing and multiplexable diagnostic for detecting and monitoring the immune marker IgE against food allergen components using IsotypeSpecific Agglutination PCRISAPtechnologyEarly identification of marking IgE can prevent severe allergic reactions by enabling allergen avoidance and linking patients to targeted immunotherapies to induce allergen de sensitizationCurrent food allergy IgE diagnostics mostly use whole food extract as antigenswhich leads to low assay specificity due to contamination from cross reactive proteinsUp topatients positive for peanut extract IgE are not at risk for severe allergic reactionsIn contrastdiagnostics that use individually purified peanut components can identify allergy risks with significantly improved accuracyHoweverthese componentresolved IgE diagnostics require large sample volumes and have high assay costs that adversely restrict their adoptionTo address these limitationsthe proposed ISAP based allergy diagnostic uses a homogenous ligationbased DNA barcoding assay to sensitively quantify multiple allergen IgE types in aL volume sampleThe sample sparing nature of the ISAP assay permits pediatric friendly near painless blood collection and also preserves precious samples for additional immunological testing such as genomic and cellular analysisNotablysince this assay uses inexpensive reagents and widely available qPCR instruments for readoutit answers the call for a low costyet easily adoptable assay for both clinical and research environmentsSpecific Aim I seeks to synthesize and characterize ISAP reagents for a peanut allergy panel and validate them with Co Investigators at the Stanford University Sean Parker Center for Allergy andampAsthma Research using samples collected from their peanut allergy immunotherapy trialPOISEDFirstwe will synthesize ISAP reagents and optimize them for cross reactivity in detecting sIgE using positive control samplesNextwe will assess potential technical pitfalls including reproducibility of the conjugation protocolstability of key reagents and potential interference from hemolytic and lipemic samplesFinallywe will perform a head to head comparison of ISAP based assays with the current standardImmunoCAPThe results from this aim will provide the basis for an ISAP based allergy test that can significantly improve pediatric and adult patient compliance and disease managementSpecific Aimexpands upon the peanut allergy panel developed in the previous aim to create aplex food allergy test that covers overof major food allergensAs beforewe will synthesize ISAP reagents for each component and validate them using pre characterized serum samplesA second head to head comparison will be performed between ISAP and ImmunoCAP using samples derived from the multi food allergy trialPOISED and MAP XIn an era of rising prevalence of food allergythe study can establish ISAP as a sample sparing assay to better serve millions of pediatric and adult patientswhile providing proof of principle for ISAP use for the detection of a wide array of other allergensincluding environmentaldrug and those implicated in asthma and dermatitis Allergy is a serious and life threatening immune disorder that diminishes the quality of life of millions of AmericansMitigating and preventing allergy requires effective diagnostics to link patients to novel immunotherapies and to monitor their responseshowever current allergy testing technologies can either detect only one allergy marker at a time at high expense with high sample consumptionor detect many markers at once with a loss of sensitivityEnable Biosciences is developing a patent pending allergy test that can detect many allergy markers at once without sacrificing quality and only requires a fraction of a drop of bloodwhich will improve testing compliance in childrenproviding allergists and their patients with the highest quality and most actionable information to improve management of allergy and allergy related disease
