Archaic, dangerous and traumatic is how a University of Notre Dame researcher describes the current method to diagnose food allergies. Doctors conduct an oral food challenge to determine how severe a person’s allergy is; for example, will they develop a mild rash after eating peanuts, or in extreme cases, go into anaphylactic shock? The death of a three-year-old boy in Alabama last month during an oral food challenge is a tragic reminder of the need for better diagnostic methods. While such an extreme reaction is rare—he’s the first child to die during the common allergy test—Dr. Bashar Bilgicer’s new method eliminates the danger.
Doctors typically conduct oral food challenges after a skin prick test or blood test to determine if a person—typically a child or teenager—is allergic to a certain food and the severity of the condition. Bilgicer says the test, which can also reveal if someone has outgrown an allergy, is the best available tool to properly diagnose the extent of the condition. The patient eats small amounts of the suspected allergen, with incremental increases, while doctors observe the results—with emergency medical equipment at the ready.
“So either they do [the oral food challenge], and they have this horrible experience, or they don’t do it, because parents don’t want to put their child through it—and rightly so,” says Bilgicer, associate professor of chemical and biomolecular engineering. “Then they don’t know the extent of the child’s condition, so they just assume the worst and try to be cautious, which causes anxiety.”
Bilgicer’s method aims to deliver the same clarity as the oral food challenge, but without the danger, because the test is conducted outside of the body using only a blood sample from the patient. Bilgicer says there are 40 to 50 smaller molecular components in a peanut that can cause an allergic response. His team designed nanoparticles—dubbed “nanoallergens”—that mimic those many components.
“When you give a peanut, you’re basically giving all of those components to the patient at once, so you don’t really know which one is the culprit—the one responsible for the [allergic] response,” says Bilgicer. “With our nanoallergens, we’re dissecting these individual components [within a peanut] and presenting them one at a time [to the patient’s blood sample]—rather than giving the whole mixture—to identify, for a given patient, which one of the components is critical. That helps us achieve a much more accurate diagnosis of the extent of the condition for that patient.”
Bilgicer has developed the test with peanuts, because the allergen has been widely studied, but he says the platform could be applied to any food allergy—eliminating the fear patients experience, because they don’t know where their allergy lies on the spectrum of severity.
“The test will show that perhaps [the patient] doesn’t really have a serious condition—they’ll just get a rash—but they don’t have to worry about their life if they were exposed to a peanut. That’s a relief,” says Bilgicer. “Or, they’re potentially going to go into serious anaphylactic shock that could endanger their life, so they know they really need to be careful about avoiding the allergen.”
His strategy to pinpoint the exact component in a peanut that triggers the allergic response also reveals what would need to be inhibited, or suppressed, in each patient to treat the allergy with a drug—preventing the allergic response from occurring at all. In actuality, Bilgicer’s work to develop such a drug is what led to the idea for the allergy test, which will likely be commercialized prior to the drug.
Bilgicer’s team has tested the allergy diagnostic tool with human samples and is working to ramp up that effort, in collaboration with the Indiana University School of Medicine, to verify the clinical data and move toward submitting the method to the U.S. Food and Drug Administration (FDA). Already backed by funding from the National Institutes of Health, Bilgicer aims to raise about $500,000 more to complete early stage development.
In the next one or two years, Bilgicer envisions a business that would deliver the test in “kit” form; doctors could conduct the evaluation on-site in the clinic or send the blood sample to a centralized testing center.
“There has to be some business minds involved to decide what would be more viable as a business model, so we can provide this service to people at minimum cost and high accuracy,” says Bilgicer.
In the world of food allergies currently riddled with anxiety, Bilgicer believes his method could deliver calm and clarity to counteract the panic created by peanuts.
Bilgicer says, in extreme cases, parents and patients live their daily lives in fear of the food allergen.
Bilgicer says the idea for the diagnostic test came out of his research to develop a drug to prevent an allergic reaction.
Bilgicer says analyzing additional patient samples will prepare the tool for submission to the FDA.