Accurate and reproducible diagnosis of peanut allergy using epitope mapping
June 2021
Mayte Suárez-Fariñas, Maria Suprun, Paul Kearney, Robert Getts, Galina Grishina, Clive Hayward, David Luta, Alex Porter, Marc Witmer, George du Toit, Gideon Lack, Rebecca Sharon Chinthrajah, Stephen J. Galli, Kari Nadeau, Hugh A. Sampson
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15 Minutes With… Jim Garner, CEO of Allergenis
According to a recent McKinsey report, more than 30 million people (5.6 million are children) in the U.S. have been diagnosed with food allergies. Their families are impacted as well, resulting in nearly 85 million Americans changing the way they eat at home and in restaurants.
Seeing this as an opportunity, and focused on the fact that the over-diagnosis rate for food allergies is more than 60 percent, biotech company AllerGenis, founded in 2017, developed a precision diagnostic platform that utilizes current state-of-the-art technology that is significantly more accurate, guiding them in their mission to ensure that food allergy sufferers are better informed around the need for making safe food choices and attaining an improved quality of life.
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AllerGenis Allergy Diagnostic Company to Present Significant Milestones at the Biotech Showcase(TM) 2021
AllerGenis LLC today announced that CEO Jim Garner will be speaking at the Biotech Showcase™ 2021. Mr. Garner's presentation will showcase the significant achievements AllerGenis has reached in its mission to develop precision diagnostic solutions that help healthcare providers better assess and manage the well-being of millions of food allergy patients.
Most notably, AllerGenis has commercially launched the first product in its pipeline, VeriMAP™ Peanut Diagnostic. With a 95% positive predictive value, VeriMAP can help reduce overdiagnosis and anxiety by minimizing false positives. As many as 60% of food allergy sufferers may be misdiagnosed, leading to unnecessary food avoidance, increased patient anxiety, and annual costs of nearly $25 billion in the US alone.
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AllerGenis and Partners Present Positive Precision Medicine Data on Tracking Peanut-Allergy Desensitization Therapy at ACAAI Virtual 2020 Annual Scientific Meeting
AllerGenis LLC today announced that positive new data about an innovative approach to track the progress of peanut allergy desensitization utilizing AllerGenis' Epitope Mapping Platform in children undergoing epicutaneous immunotherapy for peanut allergy (DBV712 250 µg) being developed by DBV Technologies, will be presented at the American College of Allergy and Asthma & Immunology (ACAAI) virtual 2020 Annual Scientific Meeting. The presentation, a partnership with DBV Technologies, is titled, "Specific Peanut Epitopes as a Biomarker for Desensitization During Epicutaneous Immunotherapy," and will be given by David Fleischer, MD, Professor of Pediatrics and Section Head, Children's Hospital Colorado, at 3:33 p.m. CST on Saturday, November 14. Access full abstract here.
The results to be presented at ACAAI are based on samples from subjects who participated in the Efficacy and Safety of Viaskin Peanut in Children with Immunoglobulin E (IgE)-Mediated Peanut Allergy (PEPITES) study (NCT02636699). This was a Phase 3, double-blind, randomized controlled trial of children aged four to 11 years with peanut allergies who were treated with DBV712 250 µg or placebo for 12 months. Daily treatment with investigational DBV712 250 µg (approximately 1/1000 one peanut) was shown to result in a statistically significant increase in desensitization in peanut-allergic children aged four to 11 years compared with placebo.
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Ovomucoid epitope-specific repertoire of IgE, IgG4, IgG1, IgA1, and IgD antibodies in egg-allergic children
November 2020
Maria Suprun, Robert Getts, Galina Grishina, Angela Tsuang, Mayte Suárez-Fariñas, Hugh A. Sampson
Allergy. 2020;75:2633–2643.
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Early epitope-specific IgE antibodies are predictive of childhood peanut allergy
August 2020
Maria Suprun MPH, Scott H. Sicherer MD, Robert A. Wood,MD, Stacie M. Jones MD, Donald Y. M. Leung MD, PhD, Alice K. Henning MS, Peter Dawson PhD, A. Wesley Burks MD, Robert Lindblad MD, Robert Getts PhD, Mayte Suarez-Fari~nas PhD, and Hugh A. Sampson MD
J Allergy Clin Immunol 2020;146:1080-8.
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AllerGenis Begins Testing Patient Samples for Peanut Allergy Using Proprietary Epitope Mapping Technology
AllerGenis LLC today announced the onset of operations at its Hatfield facility to test patient samples using its VeriMAPTM Peanut Diagnostic, a diagnostic solution for patients with peanut allergies. AllerGenis received full certification under Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform its high complexity clinical laboratory testing. This is a crucial step for the company as it begins offering VeriMAP Peanut Diagnostic to Centers of Excellence and community allergists over the next few months, with plans to expand into additional allergy centers in early 2021.
"It has been decades since the last technological breakthrough in food allergy diagnosis," says Jim Garner, CEO of AllerGenis.
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AllerGenis Announces Presentations at EAACI Digital Congress 2020
Company to present validation data of its VeriMAPTM Peanut Diagnostic and showcase the broad application of its next-generation food allergy diagnostic platform to assess response to immunotherapy
Data-driven food allergy diagnostics company, AllerGenis LLC, today announced its activities at the European Academy of Allergy and Clinical Immunology (EAACI) Digital Congress 2020, being held virtually from June 6th through 8th. AllerGenis will have two presentations at the Congress, which are include:
Thematic Poster Presentation: Repeated validation of a high-performing peanut allergy diagnostic on POISED trial subjects
Presenter: Paul Kearney, Head of Product and Clinical Development, AllerGenis; and
Late Breaking Oral Abstract Presentation: Differences in epitome response in peanut-allergic subjects treated with different immunotherapy preparations
Presenter: Dianne Campbell, VP, Scientific and Medical Affairs, Australia and New Zealand, DBV Technologies
Both presentations will be available to conference registrants from EAACI’s website up to six months after the event.
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Allergenis Aiming to Change the Way Food Allergies Are Diagnosed
AllerGenis CEO Jim Garner joined Proactive at the Biotech Showcase 2020 in San Francisco.
AllerGenis CEO Jim Garner joined Proactive at the Biotech Showcase 2020 in San Francisco. The privately-held, Pennsylvania-based company develops data-driven diagnostics to help healthcare providers more accurately and safely diagnose, assess, and monitor patients with food allergies.
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AllerGenis to Present at the 38th Annual J.P. Morgan Healthcare Conference
AllerGenis today announced that CEO Jim Garner will be presenting during the Biotech Showcase at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco. Mr. Garner’s presentation will highlight the upcoming 2020 introduction of AllerGenis’ food allergy diagnostic platform, which more than triples diagnostic precision compared to current food allergy testing.
The presentation, titled, “Revolutionizing the Diagnosis and Management of Food Allergy,” can be webcast live (Link), and will be available for streaming on the “Resources” section of the company’s website, www.allergenis.com, following the presentation.
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New Research Demonstrates Clinical Viability of Epitope Mapping Technology Platform for Food Allergy Diagnosis
Newly published peer-reviewed paper in Scientific Reports from Nature demonstrates concordance between epitope mapping and oral food challenge for diagnosing peanut and milk allergies
AllerGenis this week reported research results in Scientific Reports from Nature, in preparation for the clinical launch of its bead-based epitope mapping diagnostic platform. The study quantified and validated the performance of the platform against the widely used peptide microarray assays in clinical patient populations.
“There still remains a significant unmet for improved food allergy diagnostics,” said Bob Getts, PhD., Chief Science Officer at AllerGenis and co-author of the study. “These results demonstrate that AllerGenis’ platform not only is orders of magnitude more powerful based on throughput than conventional epitope analysis methods, but also is more sensitive and reliable than current food allergy tests and can be conducted at clinical scale. We’re excited about the potential of empowering patients to find clarity about their food allergies through our platform.”
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Novel Bead-Based Epitope Assay is a sensitive and reliable tool for profiling epitope-specific antibody repertoire in food allergy
December 2019
Maria Suprun, Robert Getts, Rohit Raghunathan, Galina Grishina, Marc Witmer, Gustavo Gimenez, Hugh A. Sampson & Mayte Suárez-Fariñas.
Scientific Reports 9, 18425 (2019).
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Food Allergy Dx Firm AllerGenis, Luminex Ink Test Development Deal
Food allergy diagnostic developer AllerGenis today announced a non-exclusive deal with Luminex for use of that company's xMAP technology to develop, market, and sell a precision food allergy diagnostic assay.
Financial and other terms of the deal were not disclosed.
The assay, which AllerGenis plans to commercialize this year, is a high-throughput, peptide bead-based test which breaks down allergenic proteins into epitopes. It then measures a patient's antibody reactivity to each epitope, generating a detailed profile that can be used by clinicians to manage the allergy.
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AllerGenis Granted Rights to Develop and Market Its Precision Food Allergy Diagnostic Using Luminex xMAP® Technology
Sensitivity of food allergy diagnosis, assessment, and monitoring will more than triple using precision, multiplexed immunoassay technology
AllerGenis, LLC today announced that it has entered into a non-exclusive agreement with Luminex Corporation (NASDAQ: LMNX). According to the terms, AllerGenis will have the rights to develop, market and sell its novel precision food allergy diagnostic assay using Luminex’s xMAP® Technology.
The agreement supports the upcoming 2019 commercialization of AllerGenis’ food allergy diagnostic platform, which more than triples diagnostic precision compared to current food allergy tests.
“We have been able to scientifically demonstrate the ability to identify food allergies with much higher precision over currently available blood tests. We’re very excited to enter into this agreement with Luminex to bring this much-needed technology to the clinical setting as soon as possible.”
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Predicting development of sustained unresponsiveness to milk oral immunotherapy using epitope-specific antibody binding profiles.
December 2018
Mayte Suárez-Fariñas, PhD, Maria Suprun, MPH, Helena L. Chang, MSa, Gustavo Gimenez, BS, Galina Grishina, MS, Robert Getts, PhD, Kari Nadeau, MDe, Robert A. Wood, MD, Hugh A. Sampson, MD.
Journal of Allergy and Clinical Immunology, 143 (3) , pp. 1038-1046.
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Mount Sinai and AllerGenis, LLC Announce Partnership to Bring Novel, Precision Diagnostics to Food Allergy Patients
AllerGenis, LLC, a data-driven diagnostic company, announced a partnership agreement with Mount Sinai Health System to develop and commercialize technology for improved food allergy detection and patient management. The diagnostic technology will provide information to both patients and clinicians.
Through this partnership, Mount Sinai has licensed its proprietary epitope mapping platform to AllerGenis. Epitope mapping is the process of identifying the binding site of an antibody on its target antigen and is instrumental in the development of this new level of diagnostics. AllerGenis will use the platform to bring novel precision diagnostics to clinicians treating patients with food allergies. Its first product will be a peanut allergy assay, which will be available in the fall of 2019, followed by a pipeline of assays for other common food allergies including milk, egg, shellfish, and tree nuts.
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A new luminex-based peptide assay to identify reactivity to baked, fermented and whole milk.
July 2018
Sackesen C, Suárez-Fariñas M, Silva R, Lin J, Schmidt S, Getts R, Gimenez G, Yilmaz EA, Cavkaytar O, Buyuktiryaki B, Soyer O, Grishina G, Sampson HA.
Allergy. 2019 Feb;74(2):327-336.
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Changes in IgE and IgG4 epitope binding profiles associated with the outcome of oral immunotherapy in cow’s milk allergy.
May 2014
Savilahti EM, Kuitunen M, Valori M, Rantanen V, Bardina L, Gimenez G, Mäkelä MJ, Hautaniemi S, Savilahti E, Sampson HA.
Pediatr Allergy Immunol. 2014 May;25(3):227-35.
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A bioinformatics approach to identify patients with symptomatic peanut allergy using peptide microarray immunoassay.
May 2012
Lin J, Bruni FM, Fu Z, Maloney J, Bardina L, Boner AL, Gimenez G, Sampson HA.
J Allergy Clin Immunol. 2012 May;129(5):1321-1328.e5.
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Development of a novel peptide microarray for large-scale epitope mapping of food allergens.
August 2009
Lin J, Bardina L, Shreffler WG, Andreae DA, Ge Y, Wang J, Bruni FM, Fu Z, Han Y, Sampson HA.
J Allergy Clin Immunol. 2009 Aug;124(2):315-22, 322.e1-3.
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