Fifty million Americans suffer from allergic diseases including asthma, rhinitis, sinusitis, dermatitis and food allergy. Allergies constitute the 6th leading cause of chronic disease and involve at least $20 billion in annual health care costs. For type I allergy, which manifests itself by elevated levels of IgE in the serum, there is a growing need for in vitro immunoassays capable of rapidly quantifying allergen-specific IgEs for the over 300 most common allergens using a single drop of blood. Such a testing modality could significantly improve the efficiency of allergy diagnosis by providing the clinician with data to design a patient-specific, cost effective program of symptom management and therapy. One promising candidate is an allergen microarray system. However, current microarray technology is not sufficiently developed to meet the rigorous demands of clinical diagnostics in terms of low cost, reliability and automation. During Phase I, AmberGen in collaboration with Clinical MicroArrays (CMA), a subcontractor on this project, plans to develop and evaluate an integrated microarray system for simultaneous in vitro measurements of hundreds of allergen-specific IgEs. This integrated system will be based on innovations in several areas of microarray technology including array substrates, method for allergen immobilization, array immunoassays and fluorescent readout. Ultra-low fluorescence array substrates will be produced and evaluated which will be based on polystyrene and nitrocellulose thin films. Novel methods of allergen attachment through covalent bonding to surfaces and by directed binding using biotin-streptavidin bridges will be evaluated. A microarray reader which features high sensitivity evanescent wave detection technology will be evaluated. The integrated system including cassette processing of disposable microarrays will be low-cost and highly automated. Dr. Lynda Schneider, an expert in the field of pediatric in vitro allergy diagnostics and Director of the Allergy/Clinical immunology Program at Boston Children's Hospital and Dr. Helen Hollingsworth, an expert in adult allergies and Director of the allergy unit at Boston University Medical Center will serve as consultants. During Phase II, a complete integrated system including a scanner and array processor, along with a prototype microarray containing several hundred antigens will be developed and evaluated in a clinical setting.
