New Technology Could Revolutionize Food-Allergen Testing

This article is sponsored and written by Allergenis.

Over 32 million Americans have food allergies, including 1 in every 13 children – or approximately two in every classroom, according to As many as 60% are over-diagnosed with current blood and skin testing, causing a mental, emotional, and financial toll on individuals, caregivers, and their families, said the National Library of Medicine.

The gold standard in diagnosing food allergies is an oral food challenge (OFC) which is anxiety-inducing, time and resource-intensive, may incur a risk of anaphylactic reactions, and is not widely available in clinical practice, according to The Journal of Allergy and Clinical Immunology. The OFC is also often required by therapeutic products during clinical trials which can inhibit trial enrollment and slow time-to-market for treatment solutions.

The Next Generation of Food-Allergy Testing  

Individuals need a comprehensive road map to know and understand exactly if they are allergic, how allergic they are, what their tolerance threshold levels are, and if they’re at increased risk of experiencing a severe or life-threatening reaction. Allergenis provides the next generation of food-allergy testing, using cutting-edge systems biology and data analytics to accurately determine allergic status and assess tolerance levels for a more informed quality of life when living with a diagnosis of food allergy.

Allergenis is first to the food allergy market offering precision molecular diagnostics with a machine-learning, AI enabled approach to predictive analytics. Additionally, Allergenis is the first food allergy test which can be initiated by a caregiver and/or individual via a partner telemedicine channel, all while receiving the necessary medical support from an allergist with expertise in managing food allergies.

The Allergenis diagnostic offers a safe, easy-to-access, surrogate to an OFC with increased accuracy over currently available blood or skin tests, according to the European Journal of Allergy and Clinical Immunology.  To develop the platform, Allergenis worked with Hugh A. Sampson, M.D., the world’s leading expert in the food allergy field at the Jaffe Food Allergy Institute at Mount Sinai, in New York City, who has devoted over 20 years to the development of the epitope technology.

Additionally, Allergenis is collaborating with 6 of more than 30 therapeutic companies, with meaningful, ongoing dialog with 10 others, to utilize our biomarkers in conjunction with clinical trials pursuing FDA-approval for needed treatments

How it Works

Allergenis utilizes an individual’s blood sample to conduct the diagnostic test. We receive the request from an allergist or from an online telehealth partner, coordinate the blood draw, and then provide the results along with a comprehensive, personalized guide to the individual and allergist.

While tolerance levels and subsequent reactions vary among individuals, existing food-allergy testing does not identify these ranges. Current blood-test options in the marketplace produce ambiguous and inaccurate results which lack a full spectrum view of an individual’s allergy.

Currently, the most commonly administered blood tests for food allergies have as high as a 60% false-positive rate, while the gold standard tool, an oral food challenge (OFC) is costly, time-consuming, and sometimes anxiety-inducing due to the potential risk of clinical reaction.  Driven by the unprecedented precision of our technology, we have achieved or are targeting over 90% accuracy for all of our assays.

The Allergenis test works by a proprietary method of analyzing epitopes, or the exact location where the IgE antibody binds to the cell and is thus recognized by the immune system. By focusing on the immunodominant epitopes versus the whole protein (IgE), Allergenis can better determine which epitopes catalyze reactions and can predict an individual’s likelihood of having a serious reaction from a food allergen.

Allergenis technology benefits the individual and also:

    • Medical providers – Improving outcomes through personalized care, generating higher revenue from increased procedures, and administration of therapy
    • Employers, Commercial and Government – Improved employee/members satisfaction, better outcomes, more efficiency, and parents are less likely to have to decide whether to work or stay home to monitor their child(ren)’s diet
    • Therapeutic Developers – Increases trial enrollment and accelerates time-to-market for treatment solutions
    • Food Industry – Increased clarity allows for more consumption of food products
    • Travel & Hospitality – Increased clarity allows reduced travel anxiety and higher utilization of services

Allergenis currently markets two scientifically validated peanut allergy tests confirming allergic status and establishing tolerance thresholds and has four additional food allergy diagnostics (addressing 85% of pediatric food allergy reactions) in the pipeline, targeting the food allergy market with a current global valuation of $39 billion, expected to grow to $66 billion by the end of 2033, according to Future Market Insights.

About Allergenis
Allergenis provides the next generation of food allergy testing, using cutting-edge systems biology and data analytics to accurately determine allergic status, tolerance levels, and risk of severe reactions for a more informed quality of life when living with a diagnosis of food allergy. The company has access to the largest repository of confirmed oral food challenge cases in the world and is paired with a proprietary technology offering up to 190 times the resolution available in existing diagnostics. The Allergenis platform offers the only food allergy diagnostic currently able to predict tolerance levels, form, and reaction types. Allergenis was founded via a collaboration with Hugh A, Sampson, M.D., Icahn School of Medicine at Mount Sinai. Allergenis owns and operates a CLIA-certified laboratory in Hatfield, Pennsylvania. For more information, visit, LinkedIn, Twitter, Facebook, and Instagram.

Jim Garner
Phone: 1.401.965.2499