The CDC reports that food allergy incidence in the U.S. is rising, with 5-8% of children now afflicted and 40% having a history of severe and potentially life-threatening reactions. In order to reduce this high incidence, new guidelines recently issued by the NIAID and also by leading allergists recommend that children between 4-6 months of age be introduced to highly allergenic foods such as peanuts, milk and eggs. In addition, children with a high propensity for allergies, such as in the case of severe eczema, should be tested for allergies prior to dietary introduction of the foods. Overall, allergy testing plays a vital role in the prevention, management and treatment of allergic disease, for example in initial diagnosis or in predicting the likelihood of anaphylaxis. The current gold standard approach for blood-based allergy testing for children (and adults) is the ImmunoCAP system (Thermo Scientific), which performs single-plex solid-phase immunoassays to measure the concentration of circulating allergen-specific IgE antibodies (sIgEs). However, ImmunoCAP, introduced more than two decades ago, lacks several critical features required to meet current and emerging pediatric food allergy testing needs including: i) ability to test for all necessary allergens from a single drop of blood collected from a heel- or finger- stick; ii) meet the high throughput needs of central testing labs; and iii) achieve lower costs. Importantly, in addition to these characteristics, new tests must meet or exceed the current diagnostic performance of ImmunoCAP. Significant progress has been made during the Phase II SBIR towards meeting these needs. AmberGen's patented AllerBead? multiplex technology has been evaluated using venous blood collected from a cohort of >650 children in collaboration with Boston Children's Hospital. AllerBead? results from 10 allergens covering the 8 most common food allergies, requiring only 100 L of blood, were compared to ImmunoCAP measurements, requiring 1 mL of blood. Average Pearson correlation (r) of AllerBead? with ImmunoCAP was 0.90, with 96% sensitivity and 97% specificity. Critical to achieving gold standard diagnostic performance was the incorporation of patented PC-PURE? technology into AllerBead? to eliminate the matrix effect which hampers multiplex immunodiagnostics. Furthermore, a prototype automated AllerBead? system was developed which produces 4,000 results/shift versus only 250 for a comparably priced ImmunoCAP instrument. The next phase of research required for commercialization will involve full implementation of an automated AllerBead? system using finger- stick collected blood. For this purpose, a large-scale IRB approved study will be performed in collaboration with Dr. Lynda Schneider at Boston Children's Hospital to compare the results from AllerBead? performed using finger- stick blood collection with ImmunoCAP testing of venous drawn blood from the same patients. High affinity PC- Microwell Plates? will be optimized to facilitate PC-PURE? automation and provide industry-leading throughput.
Pediatric allergies, which can cause severe anaphylactic reactions and whose prevalence is rapidly increasing, are the most frequently reported chronic condition in children. During Phase II, AmberGen developed AllerBead?, a high throughput and low-cost blood testing system for childhood allergies which is based on unique technology that can quantify a patient's reactivity to dozens of allergens using a single drop of blood. The goal of the Phase IIb project is to develop a fully automated AllerBead? system compatible with clinical laboratories and validate its performance on finger-stick blood from pediatric subjects.