Allergenis’ bead-based epitope assay at center of study from Mount Sinai revealing breakthrough diagnostic for peanut allergy

Allergenis today announced the results of extensive research and development of a novel diagnostic tool. A peer-reviewed journal article detailed this breakthrough advancement in the diagnosis and management of peanut allergy. The validated results can be found in a recent article, published in Allergy. Years of research and validation, conducted at the Icahn School of Medicine at Mount Sinai in New York (Icahn Mount Sinai) with Allergenis, included breaking down peanut proteins to look at select epitopes which cause reactivity in patients. Using bead-based epitope assay (BBEA), researchers were able to accurately identify the cumulative tolerated dose of patients to inform clinical management of peanut allergy. Allergenis holds the exclusive license to this technology from Mount Sinai…

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AllerGenis announced the publication of a peer-reviewed study entitled, "Accurate and Reproducible Diagnosis of Peanut Allergy Using Epitope Mapping." Conducted by leading global experts in pediatric allergy and immunology from the Icahn School of Medicine at Mount Sinai, Stanford University and Kings College, the study found the AllerGenis peanut diagnostic blood test demonstrates accuracy significantly and statistically superior to all other established diagnostic tests. The AllerGenis peanut allergy diagnostic, which relies on analyzing a small amount of blood, resulted in 93% accuracy rate as compared to an oral food challenge without the risk of triggering an allergic reaction. The study is published in the prestigious global impact journal Allergy, the official journal of the European Academy of Allergy and Clinical Immunology (EAACI).

The findings are life-changing for food allergy patients who previously turned to a potentially risky and often anxiety-producing procedure called an oral food challenge (OFC) to rule out a food allergy.

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Chief Science Officer and head of product and clinical development to present advancements in food allergy diagnostics highlighting the company's new peanut allergy sensitivity assay

AllerGenis today announced that the company's chief scientific officer and head of product and clinical development, Paul Kearney, PhD, will be speaking at the Institute for the Advancement of Food and Nutrition Science (IAFNS) Annual meeting on a panel entitled, "New Innovations in Food Allergy Testing and Patient Care.”

"I look forward to sharing how AllerGenis is shaping the future of food allergy diagnostics and the several advancements we're working hard to bring to patients and caregivers across the country," said Dr. Kearney. "This includes our newest innovation – a peanut sensitivity assay – that can determine the amount of peanut protein likely to cause an allergic reaction when ingested which may also be used when assessing the progression of peanut allergy desensitization. This advancement can positively impact the lives of millions of patients and caregivers who are navigating the complexities of life with a food allergy while also providing an easier way to safely navigate food labeling."

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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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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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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 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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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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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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