Amerimmune Allergy Testing

Our mission is to commercialize the first FDA-Cleared 'Virtual' Peanut Allergy Test

 

amerimmune’s discovery

  • The prevailing myth has been that allergy test blood samples lost their efficacy after 4 hours.

  • The results of Amerimmune's peanut-focused Basophil Activation Test (BAT), published in the peer-reviewed journal Cytometry B, revealed that with the right system samples remained usable for 48 hours. A viable "virtual" allergy test was finally possible.

  • Rate of up-regulation in a combination of surface and intra-cellular proteins allow a better performance of the assay.

 

advancing patient care

  • Basophil Activation Testing (BAT) amounts to a "Virtual Food Challenge", i.e. no more eating peanuts in a clinical setting.

  • Amerimmune's BAT represents the first significant allergy test innovation in 150 years and a patent filed with U.S. Patent Office on 04/01/2022.

  • Est. 6.1 million Americans suffer from peanut allergies.

  • Global Allergy Diagnostics Market is projected to reach $8.2 billion by 2026, with peanut allergy projected to grow at 21.9% per year through 2030.

  • Historically, blood-based allergy tests are static; they don't measure how the body reacts to allergen.

  • Amerimmune's expertise lies in specialized functional assays that measure how the body’s immune system will respond to the allergen.

  • Today, Amerimmune and its partner clinics, are the ONLY practices in the US that offer food allergy basophil activation tests as a validated CLIA/CAP assay (48 hour virtual allergy testing).

  • Amerimmune has performed over 1000 clinical grade BAT tests on samples from across the United States.

 

Why FDA Approval for a Peanut Allergy Test?

> Widespread distribution of the test.

> Prepare for changing regulatory landscape in the United States.

> Introduce improvements to the test based on new IP.

> Better assess sensitivity and specificity with a companion clinical trial.

> Increase in the therapeutics requires better diagnostics.

BAT Assay Kit Valuable for…

> Pharmaceutical companies - R&D & Clinical trials

> Academics - R&D

> Clinics and Laboratories - Patient Care

 
 

Big Pharma Investing Heavily in the

Peanut | Food Allergy Market

Today 10 other pharmaceutical organizations are developing peanut allergy treatments, including Sanofi, Genentech (Roche), and Novartis.

In August 2020, Nestle Health Sciences, acquired the maker of the first FDA-approved children’s peanut allergy treatment, Aimmune Therapeutics, for $2.6 billion.

 

Market Growth Potential

Peanut allergy is one of the most common food allergies and, in the majority of individuals, it begins early in life and persists throughout life.
The National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, has developed clinical recommendations to prevent the development of peanut allergy.
— FDA Completes Review of a Notification Regarding a Health Claim Related to Peanut Allergies 12/8/21