We have developed an innovative, high-throughput multiplex bead-based Luminex assay, enabling clear quantification and the screening of samples and epitopes with small volumes of serum or plasma. The result is a highly reliable and reproducible diagnostic tool with greater sensitivity of epitope detection compared to peptide microarrays.1
Food allergies occur when the body’s immune system is sensitive to a protein found in a particular food, known as an allergen. IgE and IgG4 antibodies react with allergens, initiating an inflammatory response, which can result in anaphylaxis in the most severe cases. Our technology uses a high resolution approach, which subdivides allergenic proteins, found in specific foods, into smaller peptides, called epitopes, and then measures the reactivity of a patient’s antibodies (IgE) to these epitopes. Using a small amount of blood from patients and high-throughput epitope mapping technology, unique patient profiles are created to show how antibodies react to allergenic epitopes. Patient profiles are stored in a database, and analyzed to give a precise diagnosis and characterization of a patient’s allergic response.
The highly multiplexed AllerGenis platform allows for an innovative diagnostic solution for patients with suspected or diagnosed food allergies. The density of information produced by the AllerGenis platform via epitope mapping technology has the granularity to produce a unique allergy signature for each patient and provides greater capability for analysis, assessment, and management.
Historically, it was thought we develop allergies to a specific protein, yet now we know the chemistry and immune response is more granular. For instance, studying IgE to whole peanut extract or even its components does not provide the specificity of the true response at the molecular level. Therefore, a higher resolution allergy test can identify the specific epitopes within a protein responsible for an allergic response in a patient.
The quantity of information produced by epitope mapping provides greater resolution for analysis with the ability to deliver definitive diagnostic results, when compared to simply looking at whole extracts or components.
Our proprietary epitope mapping platform is based on technology originally developed by Hugh Sampson, MD, of the Elliot and Roslyn Jaffe Food Allergy Institute of the Icahn School of Medicine at Mount Sinai and has been validated against the food allergy diagnosis gold standard (oral food challenge) in three separate cohorts and more than 1,000 patients. We are creating the largest food allergy knowledge-base populated by individual patient epitope signatures derived from our epitope mapping technology, clinical history and patient reported outcomes. Machine learning is being applied to analyze the database, understand allergy subtypes, and identify unique biomarkers for the purpose of refining algorithms to help improve patient care.