Less Stress Food Allergy Diagnosis? It’s here.

Food AllergiesResourcesYour Teen
Written By Janine Flannery

I was recently listening (while on the edge of my seat) to the encouraging research about the availability of a new allergen testing diagnostic. I started to dig deeper into what this could mean for my food allergic teenage son -- it was the word >> epitopes << that caught my attention.

As I began to understand more about epitopes, I realized the potential for greater diagnostic accuracy and a promising alternative to the oral food challenge has now arrived — and it’s a game changer.

Epitopes are sequences of amino acids that make up proteins. In layman’s terms, epitopes are involved in how our immune system works, recognizing invading ‘pathogens’, and eliciting a ‘response.’ For our purposes, a pathogen would be a food, and a response would involve an allergic response. (Again, this is overly simplified.)

I was listening to the CEO, Jim Garner, of Allergenis give a presentation at the FARE Food Allergy Summit 2023. The description for his talk was titled “What is Epitope Testing? -- You may have heard it called epitope mapping or BBEA (bead-based epitope assay).”

“…No matter how you refer to it, epitope mapping is an innovative and useful tool for understanding food allergy.”

It’s important to first briefly ground yourself in the evolution of food allergy diagnostic testing. You’ll see in Figure 1 -- dating back to the 1950’s, the skin prick test (SPT) was first utilized as a diagnostic tool. I’m sure many of us are all too familiar with SPT’s today – I was surprised it’s actually been around more than sixty years and still used widely today. Then came the arrival of more testing options with the oral food challenge and IgE blood testing.

Figure 1 - The evolution of food allergy diagnostic tests (Allergenis)

With more recent diagnostic tools, you may be familiar with the availability of component testing (beginning in 2009). This is a powerful diagnostic tool that can provide more detail about a food allergy beyond a positive IgE blood test (but it’s possible the term ‘component testing’ isn’t commonly used by your physicians). You may though have seen or at least discussed what the Ara H1, Ara H2, Ara H3, etc. (peanut allergy component proteins, for example) mean on your allergy blood test results. These component test results help to more deeply understand whether the proteins you are allergic to are more likely to cause an anaphylactic reaction, or are indicative of the potential for cross-reactivity. All in all, a great advancement. (Currently available for certain foods.)

Fast forward to 2021 and the availability of epitope testing, which takes blood test results a step further than component testing. Researchers have developed a way to drill down even further into a component protein to identify the specific epitopes that have been linked to greater accuracy and actionable information, providing:*  

  • The potential to replace the oral food challenge with 93% confidence

  • The first test to provide allergic reaction ‘thresholds’ – and the amount of allergen likely to cause a reaction

  • Reduction of misdiagnosis (false positive) of peanut allergy by 10x

  • A decision-making tool prior to electing desensitization treatment, such as oral immunotherapy

  • The most significant advance in peanut allergy diagnosis in 10+ years

Dr. Hugh Sampson, senior researcher and professor of pediatrics at the Icahn School of Medicine at Mount Sinai in New York City, shared that “…one of the objectives of the Allergenis epitope assay test is to find an alternative to the oral food challenge, by providing a safe and accurate way to diagnose as well as provide guidance about the symptom eliciting threshold.”

The Allergenis epitope assay test categorizes patients as either having a low, mid or high threshold to tolerate an allergic food (now only available for peanut, with other top allergens soon to come within only a matter of months) – providing a level of awareness to ease the stress of living with strict avoidance, and hopefully increasing the quality of life for those living with food allergy.

It's a win-win for patients, families and physicians. More knowledge, better decision-making, and less stress not only on the patient, but the physicians and staff. It’s impact is great – mentally, physically, personally, financially and more.

For further information, contact Allergenis to understand more about epitope testing and how to access. The testing is currently available in the US in all states except New York, where licensing is underway.

Allergenis has some great recordings available of recent webinars which may answer some of your questions, and prepare you for a discussion with your allergist and physicians.

Janine Flannery
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