Mount Sinai and AllerGenis Partner to Develop Novel, Precision Diagnostics For Food Allergy Testing

November 5, 2018
  • More than 30 million people in the US and Europe suffer from food allergies
  • One in 13 U.S. children are at risk for life-threatening anaphylaxis
  • AllerGenis is creating the largest food allergy knowledge base

AllerGenis, LLC, announced on 11/5/18 a partnership agreement with Mount Sinai Health System to develop and commercialize technology for improved food allergy detection and patient management. The diagnostic technology will provide information to both patients and clinicians.

Through this partnership, Mount Sinai has licensed its proprietary epitope mapping platform to AllerGenis. Epitope mapping is the process of identifying the binding site of an antibody on its target antigen and is instrumental in the development of this new level of diagnostics. AllerGenis will use the platform to bring novel precision diagnostics to clinicians treating patients with food allergies. Its first product will be a peanut allergy assay, which will be available in the fall of 2019, followed by a pipeline of assays for other common food allergies including milk, egg, shellfish, and tree nuts.

“We are pleased to partner with Mount Sinai on this transformational new diagnostic and further improve the lives of patients living with food allergies,” said Jim Garner, CEO and board member of AllerGenis. “The information produced by epitope mapping provides the greatest precision for food allergy assessment, with the capacity to offer definitive diagnostic, prognostic and, in the near term, predictive results reporting.”

The epitope mapping platform is based on immunologic research conducted by Hugh Sampson, MD, Director Emeritus of the Elliot and Roslyn Jaffe Food Allergy Institute at the Icahn School of Medicine at Mount Sinai. The platform subdivides protein allergens into smaller peptides, called epitopes, and measures the reactivity of a patient’s antibody levels to these epitopes. Each patient will have a unique epitope reactivity signature. AllerGenis is curating a growing database of human epitope signatures, which will help providers better assess and manage patients with food allergies.

“AllerGenis’ diagnostic technology, using epitope mapping, is expected to expand our ability to accurately diagnose patients with food allergies and, at the same time, should markedly decrease misdiagnosis,” says Dr. Sampson. “Moreover, it should greatly narrow down the number of people who would have to submit to an oral food challenge, which can potentially be extremely risky for food allergy patients.”

More than 30 million people in the United States and Europe have food allergies. Eight percent of U.S. children are estimated to have a food allergy, and one in 13 U.S. children are at risk for life-threatening anaphylaxis, underscoring the urgent need for new therapies and diagnostics to accurately assess and manage patients living with food allergies.

AllerGenis was founded out of a collaboration between Genisphere, provider of the 3DNA platform for targeted drug delivery, and Hugh Sampson MD, of the Elliot and Roslyn Jaffe Food Allergy Institute of the Icahn School of Medicine at Mount Sinai. AllerGenis’ proprietary epitope mapping technology is based on immunological research by Dr. Sampson and leverages Genisphere’s expertise in improving sensitivity of diagnostic tests. AllerGenis is creating the largest food allergy knowledge base populated by individual patient epitope signatures derived from epitope mapping, clinical history, and patient-reported outcomes to gain clinical insights.

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