providers

Diagnose peanut allergy with high confidence—95% PPV, 91% NPV. 

VeriMAPTM Peanut Diagnostic is an innovative blood-based test that has been developed and independently validated among multiple diverse cohorts (LEAP, CoFAR2, and POISED) and has produced over 4,000 patient epitope maps. VeriMAP Peanut Diagnostic, in the context of other diagnostic testing and clinical history, allows for positive peanut allergy diagnosis with a high level of confidence, which may help the allergist develop a treatment plan and lower the chances of overdiagnosis.1

 

1. Kearney P, Getts R, Hayward C, Luta D, Porter A, Witmer M, du Toit G, Lack G, Chinthrajah RS, Galli SJ, Nadeau K, Grishina G, Suarez-Farinas M, Suprun M, Sampson HA. Highly Accurate and Reproducible Diagnosis of Peanut Allergy Using Epitope Mapping. 2020. medRxiv 2020.06.19.20136002; doi:https://doi.org/10.1101/2020.06.19.20136002.

Test Performance

VeriMAP Peanut Diagnostic utilizes the the Luminex BBEA (bead-based epitope assay) which has high negative and positive predictive values (NPV and PPV) leading to more accurate monitoring of IgE-mediated events.1,2

Test Performance
1.  Kearney P, Getts R, Hayward C, Luta D, Porter A, Witmer M, du Toit G, Lack G, Chinthrajah RS, Galli SJ, Nadeau K, Grishina G, Suarez-Farinas M, Suprun M, Sampson HA. Highly Accurate and Reproducible Diagnosis of Peanut Allergy Using Epitope Mapping. 2020. medRxiv 2020.06.19.20136002; doi:https://doi.org/10.1101/2020.06.19.20136002.
2. Suárez-Fariñas, M., Suprun M. et al., Predicting development of sustained unresponsiveness to milk oral immunotherapy using epitope-specific antibody binding profiles. J Allergy Clin Immunol. 2019;143(3): 1038–1046.

Frequently Asked Questions

A. The AllerGenis test is a high throughput multiplex Luminex bead-based epitope assay (BBEA) enabling clear quantification of individual linear epitope reactivity across multiple peanut allergen proteins. It requires smaller volumes of serum or plasma compared to other blood-based allergy diagnostic tests. The test generates a highly reliable and reproducible patient reactivity signature and demonstrates greater sensitivity (higher discovery rate) of epitope detection compared to peptide microarrays and better resolution than component resolved diagnostics (CRD) (64 data points across the 3 major peanut proteins used in CRD). The AllerGenis solution has been independently validated against OFC across multiple diverse cohorts (LEAP, CoFAR2, and POISED) and has produced over 4,000 patient epitope maps. The AllerGenis solution is built upon a legacy of research and thousands of patients analyzed over more than a decade. It is supported by over 27 scientific peer-reviewed publications and presentations.

A. VeriMAP Peanut Diagnostic is an innovative diagnostic solution for patients with suspected or diagnosed peanut allergies, and the only peanut allergy blood test with 93 percent concordance with oral food challenge (OFC). VeriMAP Peanut Diagnostic provides either an “allergic” or “non-allergic” result with high confidence—PPV of 95 percent and NPV of 91 percent. Another benefit is that the patient is tested for peanut allergy without the risk of the test triggering an allergic reaction.

A. VeriMAP Peanut Diagnostic measures the IgE (binding) reactivity to immune dominant peptide epitopes of Ara h2 in human plasma and utilizes a unique algorithm to differentiate patient reactivity at specific epitopes to assess the allergic status of a patient. It is intended to be used as an aid in the clinical diagnosis of peanut allergy, in conjunction with other clinical findings.

A. VeriMAP Peanut Diagnostic provides an accurate diagnosis, without the risk of the test triggering an allergic reaction. With a 95 percent PPV and 93 percent concordance with oral food challenge, VeriMAP Peanut Diagnostic offers a safe, convenient, and accurate peanut allergy diagnosis, mitigating overdiagnosis and enabling healthcare providers to develop patient treatment plans with more confidence.

A. Current studies estimate that up to 60 percent of patients are overdiagnosed with food allergy.1 The low specificity and low positive predictive value (PPV) of skin prick testing and sIgE blood tests decrease their viability as decision-making tools to confidently diagnose a food allergy. For patients whose skin prick test or sIgE results are ambiguous, especially in the absence of IgE-mediated food-related clinical history, the chance of arriving at a definitive diagnosis with current diagnostic tools is reduced. These patients may either wait to undergo an oral food challenge (OFC) or avoid the suspected food allergen without a clear diagnosis.

With a 95 percent PPV and 93 percent concordance with OFC, VeriMAP Peanut Diagnostic provides a positive peanut allergy diagnosis with a high degree of confidence, without the risk of the test triggering an allergic reaction.

A. VeriMAP Peanut Diagnostic should be considered for patients with a history consistent with peanut allergy. This is a blood based diagnostic BBEA intended to measure specific epitope reactivity in the serum of patients with a history consistent with peanut allergy. This test is to be used to confirm a patient’s peanut allergy status in conjunction with other clinical findings.

A. To order VeriMAP Peanut Diagnostic, you will need to contact us to have an account set up. You will then gain access to an online portal for digital submission or a sales representative can provide you with a paper Laboratory Requisition. You will need to provide an address during the account set up process in order for us to either coordinate in-office draw kits or a mobile phlebotomist to draw your patient’s blood. For an in-office blood draw, follow the directions within the provided draw/ship kit to obtain the required specimen sample and ship. If your account is setup for mobile phlebotomy, we will contact the patient to schedule the blood draw.

A. The specimen requirements are a minimum of 200uL of patient plasma per test and five to seven days turnaround time.

A. If you have questions about your patient’s test results, please call Customer Support at 888-436-6339 from 9am-6pm Eastern or email support@allergenis.com. (Please do not include patient information in email.)