Over-diagnosed food allergies are a major driver of healthcare costs.
60%
Nearly 60% of food allergy patients receive false positive test results1-3
$24.8 B
In the U.S., the cost to manage food allergy in 2013 was $24.8 B or $4184 per child1
2x
The cost of avoiding a food is twice the cost of confirming with an oral food challenge5
93%
The Allergenis test may be a useful surrogate to the oral food challenge (OFC) 6 with its 93% concordance to an OFC without the risk of anaphylaxis.
Health impacts of incorrect food allergy diagnosis1
Food allergy over-diagnosis (or calling patients allergic when they are not) can harm patients, overburden families and healthcare provider offices, and elevate healthcare costs. Epitope mapping as a food allergy diagnostic platform can help change this.
32 million people in the U.S., and eight percent, or 5.9 million, of children have a food allergy.1.
Food allergies in the U.S., alone, is nearly $25 billion annually, or roughly $4,184 per child. Direct medical costs were $4.3 billion annually, including clinician visits, emergency department visits, and hospitalizations.1
Approximately 60% of food allergy patients are overdiagnosed.1-3. For many patients affected by a false-positive diagnosis, there can be a lifetime of costs associated with food allergies that are unnecessary3
Patients are prescribed epinephrine devices and/or told to avoid the allergen. LEAP (Learning Early About Peanut Allergy) has shown that avoiding peanut when not allergic, can increase a child’s odds of becoming allergic.
Confirmatory oral food challenges for children, within a year of diagnosis, is a cost-effective strategy that decreases costs and improves QOL. 5
A correct diagnosis with a gold standard oral food challenge (OFC) could potentially reduce the annual costs of food allergy by compensating for the relatively low specificity of SPT/IgE.4
The Allergenis Peanut Diagnostic has high specificity (94%) and sensitivity (92%), allowing for an accurate diagnosis.7,8
While OFCs are very useful for making an allergy diagnosis and determining clinical reactivity, they carry the risk of allergic reactions and anaphylaxis, which can increase patient anxiety and are time and resource intensive. The Allergenis platform provides diagnosis with 93% concordance with an oral food challenge and clinical reactivity levels for allergic patients, without the risk for anaphylaxis, and may provide a useful surrogate for peanut oral food challenges.6
While skin prick tests (SPT) and allergen-specific IgE (sIgE) blood tests have good sensitivity, their specificity is poor, which hinders the correct diagnosis of food allergy. They also are not validated to evaluate patient thresholds which could be helpful information to those with food allergies. This underscores the urgent need for more reliable, precise diagnostics for allergists to accurately access and manage patients.
RUCHI S. GUPTA
Director, Center for Food Allergy and Asthma Research (CFAAR)
Institute for Public Health and Medicine, Northwestern University
Identify patients that truly need and would benefit from prescriptions and/or immunotherapy
See below for summary of clinical considerations based on threshold reactivity level.1
allergenis peanut diagnostic
likely allergic - low dose reactor
epinephrine prescription needed
inform or avoid oral food challenge to reduce risk of anaphlyaxis
confirm strict avoidance of peanut
consider immunotherapy to reduce risk of reaction
allergenis peanut diagnostic
likely allergic - moderate dose reactor
epinephrine prescription needed
single oral food challenge (30 to 100 mg) to reduce anxiety and improve quality of life
less stringent avoidance of peanut regime
consider inclusion of precautionary labeled foods such as ‘May contain peanut.’
consider immunotherapy to reduce risk of reactio
allergenis peanut diagnostic
likely allergic - high dose reactor
epinephrine prescription needed
single oral food challenge (30 to 100 mg) to reduce anxiety and improve quality of life
less stringent avoidance of peanut regime
consider inclusion of precautionary labeled foods such as ‘May contain peanut.’
consider starting immunotherapy at higher doses to shorten time to maintenance dose
allergenis peanut diagnostic
unlikely allergic
oral food challenge to rule out a peanut allergy diagnosis
epinephrine prescription not needed once diagnosis ruled out
references
Gupta RS, Springston EE, Warrier MR, et al. The prevalence, severity, and distribution of childhood food allergy in the United States. Pediatrics. 2011;128(1).
Bird JA, Crain M, Varshney P. Food Allergen panel testing often results in misdiagnosis of food allergy. J Pediatric. 2015;166(1):97-100.
Food Allergy Research & Education. “Blood Tests.” Retrieved from https://www.foodallergy.org/resources/blood-tests
Gupta RS, Holdford D, Bilaver L, et al. The economic impact of childhood food allergy in the United States. JAMA Pediatr. 2013;167(11):1026-1031.
Alsaggaf A., Murphy J., and Leibel Sydney. Estimating Cost Effectiveness of Confirmatory Oral Food Challenges in the Diagnosis of Children with Food Allergy. Global Pediatric Health. 2019;6:1-11.
Suprun M., Kearney P., Hayward C., et al. Predicting probability of tolerating discrete amounts of peanut protein in allergic children using epitope-specific IgE antibody profiling. Allergy. 2022;77:3061-3069.
Suárez-Fariñas M, Suprun M, Kearney P, et al. Accurate and reproducible diagnosis of peanut allergy using epitope mapping. Allergy. 2021 Dec;76(12):3789-3797. doi: 10.1111/all.14905. Epub 2021 Jun 2. PMID: 33991353; PMCID: PMC8607840.
Sindher S., Long A., Chin A., et al. Food allergy, mechanisms, diagnosis and treatment: innovation through a multi-targeted approach. Allergy. 2022 Oct; 77(10):2937-2948.
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