for the first time
ever, threshold
data for clinical
management.
pioneering food allergy diagnostics, in that we are applying threshold data to inform clinical management for the first time.
highly informative and highly accurate diagnostics for peanut allergies.
current diagnostics have high specificity but low sensitivity.
Diagnostic tests such as skin prick testing (SPT), peanut sIgE, or component testing have a low positive predictive value for making a diagnosis of food allergy but high negative predictive value.1,2
With high concordance to OFC, the allergenis peanut diagnostic or bead-based epitope assay (BBEA) promises to significantly increase diagnostic accuracy to be greater than SPT, sIgE, and CRD for patients with food allergies.3
current diagnostics do not provide threshold data.
Despite current diagnostics launching nearly 40 years ago, there has been little development to improve accuracy or to provide threshold data for clinical management. allergenis set out to provide an accurate method of threshold assignment. We started with identifying the best test for comparison, the double- blind oral, placebo-controlled food challenge (DBPCOFC), and the best cohorts for validation.
Allergenis currently holds the largest repository of peanut allergy oral food challenge confirmed cases in the world. The peanut diagnostic was validated on over 8 cohorts. Only cohorts that had an DBPCOFC result were included in the validation of the test.
The Allergenis test, a bead-based epitope assay, will be the only validated test to provide threshold data (besides an OFC).
Difference of the Allergenis Peanut Diagnostic to Other Peanut Allergy Tests
The Allergenis Peanut Diagnostic (also known as BBEA) is different than current blood tests. It is a molecular diagnostic test that looks for the mechanistic cause of an inappropriate immune response to peanut.2,4,5
The test is more than just an improvement over past technologies; the epitope technology has allowed us to identify specific epitopes tied to an immune response. This allows us much higher specificity and sensitivity (lowering the over-diagnosis of peanut allergies).2,4,5
Testing was validated using only samples with double-blind, placebo controlled oral food challenge results (gold standard).
Testing does not require fresh whole blood; testing is performed off a small amount of plasma and takes 5-7 business days for results.
references
01. National Academies of Sciences, Engineering, and Medicine. 2017. Finding a path to safety in food allergy: Assessment of the global burden, causes, prevention, management, and public policy. Washington, DC: The National Academies Press. doi: 10.17226/23658.
02. Suarez-Farinas M, Suprun M, Kearney P, Getts R., Grishina G., Hayward C., Luta D., Porter A., Witmer M., du Toit G., Lack G., Chinthrajah R., Galli S., Nadeau K., Sampson H. Accurate and Reproducible Diagnosis of Peanut Allergy Using Epitope Mapping. 15 May 2021. Allergy.
03. Suarez-Farinas, M. et al. 2019. Predicting development of sustained unresponsiveness to milk oral immunotherapy using epitope-specific antibody binding profiles. J Allergy Clin Immunol. 2019;143(3): 1038–1046.
04. 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;00:1-9. doi: 10.1111/all.15477.
05. Sindher H, Long A, Chin R. C, et al. Food allergy mechanisms, diagnosis and treatment: Innovation through a multi-targeted approach. Allergy. 2022;00:1-12. doi: 10.1111/all.15418.
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