Q&A: Planning, diagnostics may help ensure safe holidays for families with food allergies
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The holidays provide happy opportunities for families and friends to gather and enjoy the season. However, the tasty treats served at these celebrations often present hidden dangers for families with food allergies.
Allergists can be proactive in guiding families through these hazards, including education and communication.
Healio spoke with Erin Malawer, cofounder of the Food Allergy Collaborative, to find out more.
Healio: What are the primary risks that people with food allergies face during holiday celebrations?
Malawer: The holidays can be challenging for people living with food allergies. Food brings people together. But if you have food allergies, these gatherings require advanced preparation and sometimes awkward conversation.
Not only do many people with food allergies feel excluded from food-centric holidays, but their anxiety is heightened trying to keep themselves or their loved ones safe from accidental exposure. This anxiety is justified when you consider the tempting nostalgia of traditional holiday dishes and abundance of irresistible treats, some or all of which could contain common allergens.
Holiday food is often homemade and therefore without an ingredient label to help determine safety for those with food allergies. Homemade food sometimes comes with the added social pressure to appease the cook or baker, which can put those with food allergies in an uncomfortable position.
The risk for those with food allergies is compounded by misconceptions about the condition. Well-meaning family and friends often do not understand the difference between a food allergy and a food intolerance and may not have grasped that just a very small amount of allergen is enough to send their loved ones to the hospital. Food allergies are a life-threatening condition that require constant vigilance to stay safe.
Cross-contact and cross-contamination are additional dangers to those with food allergies. Fun, holiday-themed treats are often manufactured in factories where cross-contact can occur. The ingredient lists on these products and others sometimes include a “may contain” or “made in a factory with” statement. These precautionary labels are voluntary statements. Kids with food allergies can feel left out of festive activities like decorating gingerbread houses or playing dreidel with Hanukkah gelt not because of the ingredients in the product but because of the way they are produced.
Those with food allergies worry about cross-contamination in kitchens or at the dinner table or buffet line where one cooking or serving utensil used for a dish containing an allergen could be used to stir or serve a dish without allergens that was previously safe.
Healio: How are these risks amplified for children?
Malawer: With finger food and tempting treats everywhere during the holidays, determining if a food is safe or not can be a complicated process, and children are sometimes left to navigate this on their own, such as at a school holiday party.
Children cannot always visually distinguish a safe cookie from one that contains their allergen. For example, a dairy-free, safe-sugar cookie could look identical to one that contains dairy, eggs and traces of nuts. Children are not expected to be familiar with U.S. labeling laws that govern what allergens manufacturers are required to label for and how. These laws are difficult even for adults to manage, and determining the safety of a food often involves a call to manufacturers.
Healio: What strategies can allergists use to help patients and families with food allergies prepare for possible incidental exposures?
Malawer: There are several ways allergists can help patients and their families protect themselves against accidental exposure.
First, allergists can speak with their patients about epinephrine at every visit. Recent data suggest that epinephrine is underprescribed, and prescriptions often go unfilled. Talking about the importance of this lifesaving medication and problem-solving ways to access and carry it would go a long way in protecting patients.
Next, allergists can help establish realistic risk to reduce the anxiety of patients and caregivers. Health care providers can help reduce stress by discussing everyday situations and the difference between perceived and actual risk of reactions with patients.
For example, some people with food allergies may worry that smelling their allergen is dangerous, when in most cases it is harmless. Parents often worry about their children picking up acorns that have fallen from trees or a single sesame seed that is found on a bread product. Understanding when and when not to worry is helpful in maintaining balance.
Allergists must periodically review the symptoms of anaphylaxis and review what to do if an allergic reaction begins, including if/when to use antihistamines, as well as how to position a patient. Letting children practice using a trainer epinephrine autoinjector in the office can reduce fear of the device. Reminding patients and caregivers that epinephrine is a safe medication with no harmful side effects will empower them to use it when it is needed.
Healio: How does Allergenis and its diagnostic assay build on these strategies?
Malawer: Allergenis gives those with food allergies insight into their allergy that was never available through blood testing before. The Allergenis Diagnostic can tell patients if they are truly allergic and informs them and their providers how much protein is likely to cause a reaction.
As a person with food allergies, understanding your tolerance allows you to make better everyday decisions. Because the Allergenis Diagnostic is so accurate, patients can navigate the world with confidence. Allergenis’ results give patients and their health care providers context around what constitutes a realistic risk, allow them to establish reasonable protections and accommodations to stay safe, and loosen restrictions whenever possible.
The Allergenis assays also help individuals living with food allergies and their health care providers evaluate and monitor treatment. The threshold results give both patients and allergists an idea of the urgency of treatment, which ones may be most successful, and where in the dosing schedule to begin, possibly shortening the time it takes to achieve desired tolerance.
During the holidays, this generally means less stress for those with food allergies and their caregivers. Knowing your threshold or tolerance means you may not have to fear cross-contact in the kitchen or kisses from your grandfather who can not stop snacking on peanut M&Ms. It means individuals living with food allergies and their families can breathe a little easier and enjoy themselves a little more during the holidays and throughout the year.
Healio: How does the Allergenis Diagnostic work?
Malawer: Epitope mapping, also known as bead-based epitope assay, or BBEA, is a precision diagnostic technology. Allergenis layered data-driven machine learning over epitope mapping to create this innovative, accurate diagnostic tool.
Most traditional blood tests look at whole allergen proteins to diagnose a food allergy. But allergens are made up of many proteins, and sensitivities to most of them are harmless and do not result in reaction.
Epitope mapping zooms in on these proteins and cuts through the distraction of harmless proteins to focus only on what matters. True to its name, epitope mapping analyzes epitopes, which are the small subcomponents of proteins that trigger allergic reactions.
Because it is so specific, epitope mapping delivers a more accurate diagnosis than traditional diagnostics, producing results similar to an oral food challenge but without the risk of reaction or inconvenience to patients, such as refraining from antihistamine use for weeks or spending hours in a medical facility. Where most traditional diagnostic blood tests are about 50% accurate, Allergenis’ BBEA diagnostic assay is 93% accurate.
BBEA can also predict how much allergen a patient can tolerate. This is known as a reactive threshold. It can help providers better diagnose, assess and manage patients with food allergies. It is also valuable to patients and caregivers who can use this insight to adjust their lifestyle restrictions, ask for accommodations, consider oral food challenges and pursue treatment.
Healio: Why is this information valuable?
Malawer: Accurate diagnosis is critical. An estimated 60% of those presently living with food allergy may be overdiagnosed. Traditional IgE blood tests and skin prick tests have a false positive rate of up to 50%. This means that about half the time a person is tested, they might be told they have a food allergy when they actually do not. Getting people the care they need to begin protecting themselves as well as releasing those who are overdiagnosed from the burden of food allergy is a critical part of Allergenis’ mission.
Second, threshold information is incredibly useful to patients and clinicians. Most patients are told they either have or do not have a food allergy. They can freely eat or must strictly avoid their allergen. Until now, diagnosis was starkly black or white.
Epitope mapping colors a patient’s world with insight into their individual food allergy by giving them information about how much protein they can tolerate. Threshold information can be used to determine whether someone with a food allergy can eat food with precautionary labels (like “may contain”), whether they should adjust their lifestyle and whether they should undergo treatment. It can also help justify protections and accommodations for those who are most sensitive.
Clinicians may use this information to evaluate whether a patient should proceed with an oral food challenge, assess when to begin treatment and at what dose and see how a given therapy is progressing.
Healio: How does BBEA and its data compare to other diagnostics such as skin prick testing, specific IgE and oral food challenges?
Malawer: Specific IgE tests and skin prick tests give a 50% false-positive rate. This means they correctly diagnose a food allergy only half of the time. Also, they cannot predict tolerance, only the likelihood of a patient being allergic.
BBEA is highly accurate, correctly predicting the outcome of an oral food challenge 93% of the time. Epitope mapping delivers accurate results without the anxiety, inconvenience and risk of having a reaction. These are results you can trust in a safe, more convenient testing.
Healio: What kinds of studies have been done to confirm these results?
Malawer: Epitopes have been studied since the 1990s, and there have been numerous articles published specifically on the use of epitopes and how they relate to allergies.
Allergenis validated its test using multiple, large, global clinical trial cohorts (groups of patient samples), including only the cohorts that had a confirmed, double-blind placebo-controlled OFC, which is considered the gold standard in food allergy diagnosis. The company currently holds the largest repository of peanut allergy oral food challenge-confirmed cases in the world and has performed more than 4,000 peanut diagnostic assays. The Allergenis Peanut Diagnostic is currently validated for patients over the age of 4.
Healio: Do these tests have FDA approval?
Malawer: Assays like ours, developed in our proprietary laboratory, are regulated by the federal government — specifically, HHS. The FDA does not currently have oversight over this type of testing.
Healio: Are these tests available for allergists to use?
Malawer: These assays are available nationwide in 49 states and Washington, D.C. (New York state approval, which is backed up from 2020, is still pending.) So, allergists may begin using the assays today. Patients can request the assays through our telehealth partners, working with allergists virtually.
Healio: Do you have anything else you would like to say about BBEA testing?
Malawer: Epitope mapping for food allergy was developed by world-renowned pediatric allergist Hugh A. Sampson, MD, the Kurt Hirschhorn professor of pediatrics at Icahn School of Medicine and director emeritus of the Jaffee Food Allergy Center at Mount Sinai and.
Testing requires a standard blood draw and takes 5 to 7 business days for results. Patients do not need to fast or go off antihistamines prior to testing. You can work with your own allergist or a telehealth provider to order the Allergenis Diagnostic. Testing is made even more convenient, as blood draws can be performed through pediatric-trained mobile phlebotomists at the time and location of the patient’s choice.
As a company, Allergenis is focused on health equity. As a result, we accept Medicaid for the underinsured population. For those with commercial insurance, we work with each carrier to minimize the out-of-pocket costs for individuals.
References:
- Suprun M, et al. Allergy. 2022;doi:10.1111/all.15477.
- Yost J, et al. Epinephrine autoinjector utilization and access in a nationally representative food allergic adult sample. Presented at: ACAAI Annual Scientific Meeting; Nov. 10-14, 2022; Louisville, Ky.
For more information:
Erin Malawer can be reached at erin@allergystrong.com.