New Blood Test Delivers Highly Accurate Threshold Assay That Enhances Clinical Management for Peanut Allergy

Allergenis’ bead-based epitope assay at center of study from Mount Sinai revealing breakthrough diagnostic for peanut allergy

Allergenis, a predictive data analytics company specializing in the detection and management of life-threatening food allergies, announced the results of extensive research and development of a novel diagnostic tool. A peer-reviewed journal article detailed this breakthrough advancement in the diagnosis and management of peanut allergy. The validated results can be found in a recent article, published in Allergy.

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“The development and thorough validation of the diagnostic is the result of a successful collaboration between Mount Sinai researchers and Allergenis data-analytics”

Years of research and validation, conducted at the Icahn School of Medicine at Mount Sinai in New York (Icahn Mount Sinai) with Allergenis, included breaking down peanut proteins to look at select epitopes which cause reactivity in patients. Using bead-based epitope assay (BBEA), researchers were able to accurately identify the cumulative tolerated dose of patients to inform clinical management of peanut allergy. Allergenis holds the exclusive license to this technology from Mount Sinai.

Today, existing diagnostics do not provide threshold dose information and many patients still require an oral food challenge. The new BBEA blood test offers clinicians more granular diagnostic information on a patient’s likely outcome with an oral food challenge without the risk of anaphylaxis, temporary discontinuation of antihistamines, or the time spent away from work or home to conduct the test. The results may also inform which patients are most likely to benefit from allergy immunotherapy and help monitor possible allergy resolution over time. Ultimately, by offering accurate diagnosis and threshold dose information, the BBEA may prove to be a useful surrogate for peanut food challenges.

Available for the first time, the blood test is offered through a CLIA-approved clinical reference laboratory owned by Allergenis, the key collaborator with Icahn Mount Sinai. The BBEA-technology is sole-sourced to Allergenis, which has validated the test against multiple diverse trial cohorts. The highly accurate diagnostic also minimizes false positive results and overdiagnosis.

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“The development and thorough validation of the diagnostic is the result of a successful collaboration between Mount Sinai researchers and Allergenis data-analytics,” said Paul Kearney, PhD, Strategic Advisor, Product Development and Data Science at Allergenis, “Allergies and their severity is a growing and costly concern, which is why threshold levels with validated data is vital. In collaboration with Icahn Mount Sinai, we created an algorithm using two sequential epitope-specific allergen-specific immunoglobulin E (ses-IgE) predictors. During the validation process, subjects were assigned into high, moderate, or low dose reactivity groups. On average, subjects in the high group were four times more likely to tolerate a specific dose, compared to the low group.”

Hugh A, Sampson, M.D., the Kurt Hirschhorn Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai and Director Emeritus of the Elliot and Roslyn Jaffe Food Allergy Institute, said, “We can leverage blood test results to stratify patient care and to inform appropriate clinical settings while determining if they should maintain stringent allergen avoidance and/or pursue oral immunotherapy. For example, patients with low dose reactivity may find the benefits of therapy would outweigh the time, effort, and risk of adverse reactions in treatment. Patients with moderate or high dose reactivity may benefit from a single low-dose OFC to confirm low-dose tolerance and possibly allow for less stringent avoidance protocols such as consumption of food with precautionary labeling. This level of therapeutic insight may set a new standard for the future of allergy testing.”

Brian P. Vickery, M.D., Chief of the Division of Allergy and Immunology at Children’s Healthcare of Atlanta and Associate Professor of Pediatrics at Emory University School of Medicine, said, “Allergenis is addressing the need for more accurate diagnostic testing which allows clinicians to accurately assess and help individuals and caregivers living with peanut allergies. The new reactivity threshold blood test may provide valuable insights on the potential risks associated with exposure and enables us to help each individual patient understand their threshold dose information.”

The BBEA blood test is based on technology developed by Dr. Sampson and other Mount Sinai faculty members and is licensed to Allergenis. Mount Sinai has a financial stake in Allergenis.

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