AMBERGEN, INC — Department of Health and Human Services SBIR Phase II: NIAID

Description

DESCRIPTION provided by applicant This proposal focuses on the development of a high throughput high sensitivity low blood volume multiplex assay for in vitro diagnosis of allergies termed AllerBead tm Allergies comprise a group of immune disorders constituting the th leading cause of chronic disease in the US In the case of pediatric allergies over million children ar affected a number which is rapidly increasing making it the most common chronic childhood disease Early identification of allergen triggers can be life saving and a key to managing the debilitating symptoms which can limit a childandapos s activities as well as critical for developing treatments including new forms personalized desensitizing therapies Utilization of in vitro allergen specific IgE sIgE testing especially in pediatrics has many advantages over the more common in vivo skin prick test SPT including i lower costs ii elimination of possible adverse reactions and patient intolerance of the tests particularly in pediatric subjects iii highly standardized assay procedures and allergen preparations used in the tests and iv objective quantitative readout of sIgE levels as well as automation and high throughput capability In recognition of the significant market for pediatric in vitro diagnostic allergy testing several companies have sought to develop multiplex systems designed to use only a few drops of blood to assay multiple allergens and allergen component proteins For example one approach based on use of protein microarray technology is capable of measuring allergen components simultaneously However limitations of protein microarrays including in sensitivity reproducibility scalability non linearity and expense of manufacture prevents this approach from replacing the more widely used one by one allergen assays such as ELISA and Phadiaandapos s ImmunoCAP in the pediatric market In contrast AmberGen has developed and evaluated during Phase I a high sensitivity high throughput low cost multiplex immunoassay approach by adapting the VeraCode digital holographic micro bead technology developed by Illumina for genomic applications The heart of this new approach relies on proprietary methods developed by AmberGen including the use of cell free protein expression for uniform and reproducible production of highly pure allergen components low immunogenic step protein attachment to the bead surface and elimination of interfering IgGs using photocleavable antibodies Significantly Phase I results based on a multiplex assay of allergens from the major food groups achieved all major aims This work demonstrated that AllerBeadTM results in sensitivities and CVs similar to the gold standard FDA approved ImmunoCAP assays for individual allergens but is capable of automatically and rapidly assaying samples for up to individual allergens from only L of blood per patent During Phase II the most comprehensive and low cost blood test for childhood food allergies comprising allergen proteins and whole food extracts including all of the andquot Big andquot food groups which account for andgt of all childhood food allergies will be developed Results using AllerBead technology will be compared with measurements obtained commercially from the non multiplexed ImmunoCAP assay and also on the multiplexed Phadia ISAC Microarray For the purpose of assay validation and eventual FDA approval AmberGen will work closely with INOVA Diagnostics and collaborate with Dr Lynda Schneider M D Director of the Allergy Program at Childrenandapos s Hospital Boston Associate Professor of Pediatrics Harvard Medical School who will provide validated blood samples under IRB approval Dr Paul Billings the Chief Medical Officer at Life Technologies and Dr Kevin Xie former Head Global Strategic Business Development at Boehringer Ingelheim and at Bayer Healthcare will also serve as consultants PUBLIC HEALTH RELEVANCE Allergic diseases in the U S affect times more persons than cancer and times more than diabetes making it a major public health concern The diagnosis of pediatric allergies is particularly important because it is the most frequently reported chronic condition in children can cause severe anaphylactic reactions and its prevalence is rapidly increasing During Phase II AmberGen will continue development of a comprehensive and low cost blood test for childhood allergies based on unique technology that allows less than a drop of blood to be rapidly assayed in order to identify sensitivity to hundreds of different allergens