Research Project
9623919
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 µL 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.
