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Allergenis Seeks to Change Peanut Allergy Testing


NEW YORK — Pennsylvania-based firm Allergenis plans to change the model for peanut allergy testing with its blood test, which it said can reduce false diagnoses of peanut allergies and give nuanced results that will help patients manage their individual risk.

According to Allergenis, its laboratory-developed test produces fewer false positive results than other first-line assays — skin prick and peanut-specific immunoglobulin E tests — and fewer false negative results than skin prick tests in young patients. Additionally, collecting blood for the test is less stressful than an hourslong oral food challenge that is conducted under medical supervision in case a patient has a severe reaction.

In a study conducted with the Mount Sinai Icahn School of Medicine and published in Allergy last month, researchers demonstrated that Allergenis' bead-based epitope assay could identify a patient's cumulative tolerated dose of peanut protein, which can aid clinical management. Allergenis has an exclusive license to that technology from Mount Sinai, and it is making the assays available through food allergy clinics and home-delivered collection kits.

Hugh Sampson, director emeritus of the Jaffe Food Allergy Institute pediatrics at the Icahn school and one of the researchers behind Allergenis' technology, said test results that identify a patient's predicted level of peanut sensitivity can help doctors decide who would benefit the most from immunotherapy and give the patients and their families better perspective on how vigilant they need to be in avoiding peanut protein. Some may feel more comfortable eating in restaurants or buying foods that have label warnings that they were made in facilities that also process nuts, he said.

"It also greatly relieves the anxiety of parents and families of children who we know will be able to tolerate a small amount of protein without having a reaction," he said.

Peanut allergy is one of the most common food allergies in children. Negative results in a skin prick or peanut-specific IgE test can help rule out peanut allergy, but positive results can be misleading because the severity of a patient's reaction doesn't necessarily correlate with an actual allergy, according to a 2020 review article from the journal Pediatrics.

The authors noted that a prior review found that this misunderstanding — mistaking sensitization for allergy — may be the greatest source of misdiagnosis of food allergy.

Allergenis said study results show its test is 93 percent accurate, a measurement achieved by testing patients with both the Allergenis assay and oral food challenge and comparing the results. The assay has 92 percent sensitivity, which is comparable to skin prick and IgE tests. Its big advantage is its 94 percent specificity.

According to the Pediatrics article, skin prick tests are more than 90 percent sensitive while blood tests for peanut-specific IgE are 70 percent to 90 percent sensitive. But the specificity of either test falls between 50 percent and 60 percent.

Paul Kearney, strategic adviser for product development and data science at Allergenis, said existing allergy tests introduce allergy-linked proteins to a person's blood and check whether the immune system binds to those proteins. Allergenis instead deconstructs the proteins and makes synthetic copies of only the key epitopes that cause chain reactions with the immune systems of people who have allergies.

"The biology of allergy is at the epitope level; it's not at the protein level," he said.

The firm identified the epitopes for peanut allergies through proteomics-based work and machine learning, Kearney said. It uses DiaSorin subsidiary Luminex's bead-based epitope assay, which applies fluorescence to measure the reaction.

Allergenis CEO Jim Garner said the company is trying to raise consumer demand for the tests, which it sells through telemedicine consultations and in-person clinics that specialize in food allergies. Allergenis announced last month a partnership that made telehealth provider LifeMD, through its subsidiary Cleared, the exclusive provider for the commercial launch of Allergenis' direct-to-consumer channel.

"We're in-market; we have two channels: a consumer-enabled channel and a direct-to-the-physician channel," he said.

Allergenis' peanut allergy assay is priced at $1,450. Garner said the company has established reimbursement by the US Centers for Medicare and Medicaid Services, started the state-by-state credentialing process for Medicaid contracts, and is early in establishing reimbursement by commercial insurers.

"We're still very early, but we are seeing success at getting reimbursed," he said.

The test is licensed in every state except New York, where Allergenis was working toward licensing, Garner said. The company also had been pursuing other testing indications based on market demand, and the next three products will be assays for allergies to milk, eggs, and tree nuts.

"Peanuts and tree nuts are responsible for 90 percent of the severe reactions," Garner said.

The company also could someday pursue assays related to non-allergy indications such as Lyme disease, Garner said. Kearney said lupus and other autoimmune diseases would be the natural next targets outside allergy, although the company already has its hands full with allergies.

Garner said Allergenis also had contracts to develop biomarkers for five companies that are testing peanut allergy therapies and was in negotiations with a sixth.

"We're at the forefront of this boom," he said. "Other competitors will come in, and we'll welcome the competition, but right now, we're really leading the way there."