Predictive analytics company Allergenis, which specializes in the detection and management of life-threatening food allergies, announced today a breakthrough diagnostic tool for the detection and management of peanut allergy developed with researchers at the Icahn School of Medicine at Mount Sinai. The bead-based epitope assay (BBEA) looks at select epitopes known to cause patient reactivity to accurately identify the cumulative tolerated dose of patients to inform clinical management of peanut allergy.
“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, Ph.D., 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.”
For their work, the Mount Sinai/Allergenis team broke down the proteins in peanuts to examine select epitopes known to cause reactivity in patients, as the basis for the new BBEA which provides clinicians with threshold dose information. The test provides a safer more effective way to develop treatment plans for patients with a peanut allergy, which today still requires many of them to undergo an oral food challenge.
The BBEA test offers more granular information on a patient’s likely outcome to the oral food challenge and eliminates the risk of anaphylaxis and the temporary discontinuation of antihistamines. The test could be used in the future to help identify which patients may benefit from immunotherapy approaches to treatment as well as monitoring patients over time for allergy resolution. It could also become a surrogate test for current peanut food challenges.
“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,” said Hugh A, Sampson, M.D., a professor of Pediatrics at the Icahn School of Medicine at Mount Sinai, who, along with Mount Sinai colleagues, developed the underlying technology. “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.”
Allergenis said the blood test is now offered through its CLIA-approved clinical reference laboratory. The BBEA-technology is licensed exclusively from Mount Sinai to Allergenis, which has validated the test against multiple diverse trial cohorts. The diagnostic also minimizes false positive results and over diagnosis.