Multiplexed Bead-based In Vitro Pediatric Allergy Test

The CDC reports that food allergy incidence in the U Sis risingwithof children now afflicted andhaving a history of severe and potentially life threatening reactionsIn order to reduce this high incidencenew guidelines recently issued by the NIAID and also by leading allergists recommend that children betweenmonths of age be introduced to highly allergenic foods such as peanutsmilk and eggsIn additionchildren with a high propensity for allergiessuch as in the case of severe eczemashould be tested for allergies prior to dietary introduction of the foodsOverallallergy testing plays a vital role in the preventionmanagement and treatment of allergic diseasefor example in initial diagnosis or in predicting the likelihood of anaphylaxisThe current gold standard approach for blood based allergy testing for childrenand adultsis the ImmunoCAPsystemThermo Scientificwhich performs single plex solid phase immunoassays to measure the concentration of circulating allergen specific IgE antibodiessIgEsHoweverImmunoCAPintroduced more than two decades agolacks several critical features required to meet current and emerging pediatric food allergy testing needs includingiability to test for all necessary allergens from a single drop of blood collected from a heelor fingerstickiimeet the high throughput needs of central testing labsand iiiachieve lower costsImportantlyin addition to these characteristicsnew tests must meet or exceed the current diagnostic performance of ImmunoCAPSignificant progress has been made during the Phase II SBIR towards meeting these needsAmberGenandapos s patented AllerBeadmultiplex technology has been evaluated using venous blood collected from a cohort of andgtchildren in collaboration with Boston Childrenandapos s HospitalAllerBeadresults fromallergens covering themost common food allergiesrequiring onlyL of bloodwere compared to ImmunoCAPmeasurementsrequiringmL of bloodAverage Pearson correlationrof AllerBeadwith ImmunoCAPwaswithsensitivity andspecificityCritical to achieving gold standard diagnostic performance was the incorporation of patented PC PUREtechnology into AllerBeadto eliminate the matrix effect which hampers multiplex immunodiagnosticsFurthermorea prototype automated AllerBeadsystem was developed which producesresults shift versus onlyfor a comparably priced ImmunoCAPinstrumentThe next phase of research required for commercialization will involve full implementation of an automated AllerBeadsystem using fingerstick collected bloodFor this purposea large scale IRB approved study will be performed in collaboration with DrLynda Schneider at Boston Childrenandapos s Hospital to compare the results from AllerBeadperformed using fingerstick blood collection with ImmunoCAPtesting of venous drawn blood from the same patientsHigh affinity PCMicrowell Plateswill be optimized to facilitate PC PUREautomation and provide industry leading throughput Narrative Pediatric allergieswhich can cause severe anaphylactic reactions and whose prevalence is rapidly increasingare the most frequently reported chronic condition in childrenDuring Phase IIAmberGen developed AllerBeada high throughput and low cost blood testing system for childhood allergies which is based on unique technology that can quantify a patientandapos s reactivity to dozens of allergens using a single drop of bloodThe goal of the Phase IIb project is to develop a fully automated AllerBeadsystem compatible with clinical laboratories and validate its performance on finger stick blood from pediatric subjects