Victoria Johnson joined MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and is now an assistant managing editor for HCPLive and RheumatologyLive. She doesn’t have enough time for her various hobbies. You can reach her at vjohnson@mjhlifesciences.com.

Biologic therapy for obstructive airway disease has moved well beyond a single anti-IgE option, with 7 agents now available for 

 and 2 approved for chronic obstructive pulmonary disease (COPD) with type 2 inflammation. Recent additions include FDA approvals of dupilumab and mepolizumab for eosinophilic COPD and of depemokimab, a twice-yearly anti-interleukin (IL)-5 agent, for severe eosinophilic asthma.

 With more options available, clinicians face growing questions about when to escalate, how to choose among agents, and how payer policies shape those decisions.

On September 17, 2026, Joseph Khabbaza, MD, a pulmonologist at Cleveland Clinic, moderated a virtual clinical forum on type 2 inflammation and biologic therapy in asthma and COPD. Participants included pulmonologists, critical care physicians, physician assistants, and a critical care pharmacist from Cleveland Clinic and other health systems in Ohio and California. The discussion covered biomarker use, oral corticosteroid (OCS) thresholds, agent selection, and unmet needs in COPD.

Biomarkers and OCS Thresholds for Biologics in Asthma

Participants described routinely documenting blood eosinophil counts at the first visit, even in patients with stable disease, so that a biologic option is established if control worsens. Several noted that fractional exhaled nitric oxide offers useful clues but is not available at every facility and is rarely sufficient on its own for payer approval. For patients referred on chronic steroids, whose eosinophils are often suppressed, participants said they rely on historical counts or on exacerbation history to support coverage.

Most participants cited 2 or more OCS-treated exacerbations per year as their trigger for considering a biologic. Some described lower thresholds for younger patients, given decades of potential cumulative exposure, and 1 participant said a cumulative dose of approximately 500 mg of prednisone in a year would prompt escalation. Participants also noted that steroid courses prescribed in urgent care or other health systems often go undocumented, and that not every course reflects a true exacerbation.

Beyond exacerbations, participants described pursuing biologics for patients with persistent daily symptoms or low FEV1 who do not exacerbate frequently, while acknowledging that coverage is harder to obtain. Several stressed confirming the diagnosis first, citing mimickers such as subglottic stenosis.

Participants said comorbidities such as nasal polyps, atopy, eczema, and eosinophilic esophagitis often guide selection when several agents are appropriate, alongside dosing interval and patient preference. Several noted that insurer formularies increasingly determine which agent is started. At 1 participant's center, an internal prescribing algorithm and a monthly case conference guide decisions for patients who have cycled through multiple biologics.

Participants who use dupilumab frequently cited its use in steroid-dependent asthma, patients with elevated IgE, and its relative ease of approval. Another participant described avoiding dupilumab when eosinophil counts approach 1000 cells/µL or when patients have autoimmune or inflammatory conditions such as psoriatic arthritis or sarcoidosis, citing case reports of immune shifts.

Within the IL-5 class, some participants favored mepolizumab for its broad indications and the familiarity of its safety data, while others preferred benralizumab for more complete eosinophil depletion and every-8-week maintenance dosing. Participants who have prescribed depemokimab described using it for patients with severe eosinophilic asthma without major comorbidities who prefer twice-yearly dosing. Tezepelumab was described as an option for patients who do not meet biomarker thresholds for other agents, and mucus plugging data for both dupilumab and tezepelumab were reviewed, though most participants said plugging does not yet change their selection.

Eosinophilic COPD and Biologic Escalation

Khabbaza noted that an estimated 20% to 40% of patients with COPD have type 2 inflammation. In the BOREAS and NOTUS trials, dupilumab reduced exacerbations and improved prebronchodilator FEV1 in patients with eosinophil counts of 300 cells/µL or higher despite triple therapy, and in MATINEE, mepolizumab reduced exacerbations with a safety profile similar to placebo.

 Before escalation, participants emphasized confirming inhaler adherence and addressing other drivers, including noninvasive ventilation for hypercapnic respiratory failure and endobronchial valves for hyperinflation.

Some participants favored mepolizumab, citing its eligibility threshold of 150 cells/µL, while others favored dupilumab for patients with chronic bronchitis, counts above 300 cells/µL, or a priority on preserving FEV1. Khabbaza said dupilumab remains his first choice in COPD, though payer barriers have led him to start mepolizumab earlier in some patients. Participants described responses in COPD as more modest than in asthma, though 1 participant reported fewer hospitalizations after starting dupilumab and described both agents as well tolerated.

For unmet needs, participants cited earlier identification of frequent exacerbators, better inhaler education resources, and therapies for patients without type 2 inflammation. 

"I think anything, less steroids, less hospital, and less symptoms are all going to be big victories," Khabbaza said.

Jackson DJ, Wechsler ME, Jackson DJ, et al. Twice-yearly depemokimab in severe asthma with an eosinophilic phenotype. 

. 2024;391(24):2337-2349. doi:10.1056/NEJMoa2406673

Bhatt SP, Rabe KF, Hanania NA, et al. Dupilumab for COPD with type 2 inflammation indicated by eosinophil counts. 

. 2023;389(3):205-214. doi:10.1056/NEJMoa2303951

Bhatt SP, Rabe KF, Hanania NA, et al. Dupilumab for COPD with blood eosinophil evidence of type 2 inflammation. 

. 2024;390(24):2274-2283. doi:10.1056/NEJMoa2401304

Sciurba FC, Criner GJ, Christenson SA, et al. Mepolizumab to prevent exacerbations of COPD with an eosinophilic phenotype. 

. 2025;392(17):1710-1720. doi:10.1056/NEJMoa2413181

Articles

Participants described how comorbidities, payer formularies, and patient preference shape biologic choice in asthma and COPD.

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

COPD

COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

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Clinical Forum Weighs in: Biologic Selection in Asthma and COPD

Nicholas Shaheen, MD, MPH, is the Bozymski-Heizer Distinguished Professor of Medicine at the University of North Carolina School of Medicine and the Senior Associate Dean for Clinical Research at UNC.

A swallowable capsule-sponge device paired with a DNA methylation biomarker panel detected Barrett’s esophagus (BE) with 90% sensitivity and 86% specificity in the prospective, multicenter DETECT-ME study. The late-breaking results were presented at the 

American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting

 an estimated 70% to 90% of patients eligible for BE screening in the US never undergo it, and EAC incidence has risen roughly fivefold over the past 4 decades. He said DETECT-ME was designed to test whether nonendoscopic sampling could move screening out of the endoscopy unit and into primary care.

“Can we democratize screening so that it isn’t tethered to an endoscopy unit? That’s the bigger question that we’re asking with DETECT-ME,” said Shaheen.

DETECT-ME: Can a Swallowable Sponge Fix Barrett’s Esophagus Screening?

DETECT-ME Study Design and Methylation Biomarker Panel

DETECT-ME enrolled patients at 18 sites, including high-risk patients undergoing screening upper endoscopy and patients with known BE presenting for surveillance or endoscopic eradication therapy.¹ Participants underwent sampling with the EndoSign cell collection device before esophagogastroduodenoscopy (EGD), which served as the reference standard.

The device consists of an encapsulated sponge attached to a string. After the capsule dissolves in the stomach, the expanded sponge is withdrawn through the esophagus, collecting cells. Investigators assessed DNA methylation at 654 BE-associated regions and 1561 reference regions, using a rank-based score to estimate the likelihood of BE.

The primary analysis population included 324 patients: 181 with BE and 143 without, with 156 undergoing screening and 168 undergoing surveillance or eradication therapy.

 Shaheen said patients with known BE were included to enrich the study population, since only about 10% of a typical screening population has the condition.

Capsule-Sponge Sensitivity by Barrett’s Segment Length and Dysplasia

Overall sensitivity was 90% (163/181; 95% CI, 84%-94%), and specificity was 86% (123/143; 95% CI, 79%-91%). Sensitivity increased with segment length: 82% (95% CI, 73%-89%) for short-segment BE and 99% (95% CI, 94%-100%) for long-segment BE.

Sensitivity was 100% (46/46) among patients with any dysplasia or EAC and 87% among those with nondysplastic BE.

Shaheen said no patient with 3 cm or more of BE was missed, and most false negatives occurred in patients with about 1 cm of disease, the group at lowest cancer risk.

Sensitivity was lower in the high-risk screening group (69%) than in patients with known BE (92%), which the investigators attributed to the shorter BE segments in the screening group.

Tolerability and Path to Primary Care Barrett’s Screening

Cell collection succeeded in 95% of participants, with no device-related adverse events.¹ The mean tolerability score was 2.0 on a 10-point scale, with 82% rating tolerance as excellent and 95.5% as acceptable. Overall, 81% of participants said they would be willing to repeat the procedure.

Shaheen said tolerability is essential for broad adoption. He envisions gastroenterologists partnering with primary care practices to offer the test during routine visits and refer only positive patients for EGD, increasing the yield of each endoscopy.

“We have a failed paradigm now, and so we’ve got to think differently,” he explained. “If we keep doing what we’ve always done, we’re going to keep getting what we’ve always got.”

ACG guidelines support screening in patients with chronic reflux and additional risk factors, and endorse nonendoscopic capsule devices combined with a biomarker as an acceptable alternative to endoscopy.

Editors’ note: Shaheen reports relevant disclosures with Cyted, Lucid, Phathom Pharmaceuticals, Medtronic, and others.

Shaheen NJ, et al. A prospective, multicenter cohort study of a novel methylation biomarker panel using non-endoscopic cell collection to detect Barrett’s esophagus: the DETECT-ME study. Presented at: American College of Gastroenterology 2026 Annual Scientific Meeting; October 9-14, 2026; Nashville, TN.

Shaheen NJ, Falk GW, Iyer PG, et al. Diagnosis and management of Barrett’s esophagus: an updated ACG guideline. Am J Gastroenterol. 2022;117(4):559-587. doi:10.14309/ajg.0000000000001680

Videos

Nicholas Shaheen, MD, MPH, discusses DETECT-ME data showing a capsule-sponge methylation test detected Barrett’s esophagus with 90% sensitivity.

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

DETECT-ME: Swallowable Sponge Test for Barrett’s Esophagus Screening

Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives

 is moving into clinical practice, raising questions about who to screen, how to stage results, and how to deliver disease-modifying therapy at scale.

Diabetes Dialogue: Screening, Cell Therapy, and Adjunctive Agents at Breakthrough-T1D

On a recent episode of Diabetes Dialogue, hosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, recapped the inaugural Breakthrough T1D Clinical and Research Congress in Philadelphia.

First-degree relatives carry up to a 15-fold increased risk, and screening children at ages two, six, and 10 years identifies roughly 80% of those who will develop the disease. Evidence guiding adult screening and staging remains limited. One health system estimated up to 45,000 candidates after counting relatives and people with 

Placebo-controlled designs, such as the 14-day intravenous infusion regimen in the teplizumab (Tzield) TN10 trial, burden participants. An ongoing comparison of antithymocyte globulin with teplizumab gives every participant active therapy, and involving people with T1D in protocol development may improve enrollment. Eli Lilly is also investigating the Janus kinase inhibitor baricitinib (Olumiant) to delay progression from stage two to stage three disease.

Stem cell-derived islet programs from Vertex aim to overcome donor scarcity, with gene editing intended to reduce immunosuppression requirements. Reports of insulin independence with tegoprubart, an anti-CD40 ligand antibody from Eledon, involve few patients receiving infusions every three weeks, and long-term toxicity of agents such as tacrolimus remains a concern. Long-term Edmonton protocol data show many recipients sustain time in range above 90% despite resuming insulin.

Adjunctive agents layered on automated insulin delivery address residual cardiorenal risk. Dipeptidyl peptidase-4 inhibitors improve time in range without added hypoglycemia, while generic dapagliflozin lowers mean glucose but requires ketone monitoring given euglycemic diabetic ketoacidosis risk. Glucagon-like peptide-1 (GLP-1) and dual GIP/GLP-1 receptor agonists improve time in range, often at low doses such as tirzepatide (Mounjaro) 2.5 mg weekly.

Finerenone (Kerendia) recently gained approval for chronic kidney disease associated with T1D. The 2026 American Diabetes Association Standards of Care also recognize coexisting type 1 and type 2 diabetes, supporting coverage for patients with insulin resistance.

Supply policy compounds the clinical burden. Continuous glucose monitoring sensors frequently fail before their labeled wear time, leaving patients on standard monthly allotments without a sensor for meaningful stretches.

Collectively, these developments point toward individualized T1D care matched to disease stage and residual beta-cell function, with screening infrastructure, trial access, and supply policy shaping how quickly patients benefit.

Editors’ Note: Isaacs reports disclosures with Dexcom, Abbott, Lilly, Novo Nordisk, Medtronic, Insulet, and others. Bellini reports disclosures with Abbott Diabetes Care, MannKind, Povention Bio, and others.

Breakthrough T1D. Breakthrough T1D Concludes Inaugural Clinical & Research Congress, Highlighting Global Advances in Type 1 Diabetes Research. October 12, 2026. Accessed October 15, 2026. 

https://www.breakthrought1d.org/for-the-media/press-releases/breakthrough-t1d-concludes-inaugural-clinical-research-congress-highlighting-global-advances-in-type-1-diabetes-research/

Podcasts

Diana Isaacs, PharmD, and Natalie Bellini, DNP, recap the first-ever Breakthrough T1D Clinical and Research Congress.

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The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

This page also hosts content previously published by EndocrinologyNetwork. 


Type 1 Diabetes

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

Diabetes Dialogue

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP, aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care.

Strategic Alliance Partnership

Among patients with moderately to severely active 

 who responded to mirikizumab (Omvoh) induction, 27.7% reached comprehensive disease control (CDC) at week 52, compared with 14.0% of patients who switched to placebo. The findings are from a post hoc analysis of the phase 3 LUCENT-1 and LUCENT-2 trials presented at 

United European Gastroenterology (UEG) Week 2026

, held October 17 to 20 in Barcelona, Spain.¹

Reaching Comprehensive Disease Control in UC, With Stefan Schreiber, MD

Among patients without prior biologic failure, 30.0% reached CDC with mirikizumab.

“This is remarkable if you consider that it means one out of three bio-naive patients will have their disease completely shut down by the therapy,” Stefan Schreiber, MD, of the Department of Internal Medicine at University Hospital Schleswig-Holstein, Christian-Albrecht University of Kiel, in Germany, said in an interview with 

. “It’s not healed, obviously, because you cannot stop the therapy, but it’s completely controlled.”

Mirikizumab, an interleukin (IL)-23p19 antagonist, was 

 for moderately to severely active ulcerative colitis in October 2023, based on the LUCENT program.²

In the moderated poster, “Mirikizumab Therapy Enables Comprehensive Disease Control with Improved Quality of Life in Patients with Moderately-to-Severely Active Ulcerative Colitis: A Post-Hoc Analysis of Phase 3 LUCENT-1 and LUCENT-2 Trials,” Schreiber and colleagues evaluated CDC at week 52 using a definition informed by an international Delphi consensus in 

A second definition added Inflammatory Bowel Disease Questionnaire (IBDQ) remission, a total score ≥170.¹

The analysis included 544 patients who responded to 12 weeks of intravenous mirikizumab induction. They were rerandomized 2:1 to continue subcutaneous mirikizumab 200 mg (n = 365) or switch to placebo (n = 179) every 4 weeks.¹

Overall, 27.7% of patients receiving mirikizumab reached CDC at week 52, compared with 14.0% receiving placebo (

 = .002). Among patients without prior biologic failure, rates were 30.0% vs 16.5% (

 = .027), and among those with prior biologic failure, 23.4% vs 9.4% (

When IBDQ remission was added to the definition, 25.2% of patients receiving mirikizumab reached CDC, compared with 12.3% receiving placebo (P = .002).¹

Among patients without prior biologic failure, disease duration was the only baseline characteristic with a significant difference. With IBDQ remission included, 32.2% of patients with ulcerative colitis for <7 years reached CDC, compared with 18.2% of those with ulcerative colitis for ≥7 years.¹

CDC Associated With IBDQ Quality of Life Remission

Among patients treated with mirikizumab, 91.1% of those who reached CDC also reached IBDQ remission, compared with 65.2% of those who did not (

Because most patients who reached CDC were already in quality of life remission, adding IBDQ remission to the definition lowered CDC rates only slightly, from 27.7% to 25.2%.¹

“If you have achieved the morphologic and symptom-based parameters in this combined endpoint, you have also regained your quality of life,” Schreiber said. “Adding quality of life remission on top of that doesn’t sharpen your endpoint any further.”

Editors’ Note: Disclosures for Schreiber include AbbVie, Amgen, Arena Pharmaceuticals, Bristol Myers Squibb, Boehringer Ingelheim, Celltrion, Dr Falk Pharma, Ferring, Fresenius, Galapagos, Genentech, GSK, Gilead, I-MAB Biopharma, Janssen, Lilly, Merck, Novartis-Sandoz, Pfizer, Protagonist, Takeda and Theravance.

Schreiber S, Magro F, Danese S, et al. Mirikizumab therapy enables comprehensive disease control with improved quality of life in patients with moderately-to-severely active ulcerative colitis: a post-hoc analysis of phase 3 LUCENT-1 and LUCENT-2 trials. Presented at: UEG Week 2026; October 17-20, 2026; Barcelona, Spain.

D’Haens G, Dubinsky M, Kobayashi T, et al. Mirikizumab as induction and maintenance therapy for ulcerative colitis. 

. 2023;388(26):2444-2455. doi:10.1056/NEJMoa2207940

Schreiber S, Danese S, Dignass A, et al. Defining comprehensive disease control for use as a treatment target for ulcerative colitis in clinical practice: international Delphi consensus recommendations. 

. 2024;18(1):91-105. doi:10.1093/ecco-jcc/jjad130

Mirikizumab LUCENT data from UEG Week 2026: 27.7% reached comprehensive disease control at week 52, with high IBDQ remission rates.

Inflammatory Bowel Disease

On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

Ulcerative Colitis

Ulcerative Colitis condition center page, resources on the topics of medical news and expert insight into colitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on UC research, treatment, and drug development.

Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

Featured: Benjamin W Casterline, MD, PhD (bottom left), Shaun Cross, PhD (top), and Chirag Patel, MD (bottom right)

As the lone star tick pushes into new parts of the country, a familiar pattern is following it into clinics.

A patient with recurrent nausea and abdominal cramping sees a gastroenterologist. The workup comes back clean. Symptoms keep returning, often hours after dinner or in the middle of the night. After months or even years of searching, the patient has their gallbladder removed, hoping it will finally help.

It doesn’t. The episodes continue because the gallbladder was never the problem. The patient has alpha-gal syndrome (AGS), a 

 to a sugar found in red meat and other mammalian products.

“It’s because of [this misdiagnosis that] these people will continue to be exposed to whatever allergen it may be,” said Shaun Cross, PhD, assistant professor in the department of environmental, agricultural, and occupational health at the University of Nebraska Medical Center, in an interview with 

As the lone star tick expands its range, AGS is reaching patients and clinicians who never have encountered it. An estimated 450,000 people in the US may be affected, and a growing number of states now require it to be reported.

Beyond gallbladder removal, there have been several reports of patients undergoing exploratory surgery or appendectomy before receiving an AGS diagnosis.

 Although these cases have been described, no study has yet quantified how many patients with AGS undergo such procedures before diagnosis.

Alpha-Gal Syndrome Diagnosis Delays & The Clinician Knowledge Gap

When do reactions occur, and are they hours after eating or overnight?

Where was the patient, and what were they doing, when symptoms began? For example, handling animals or calving.

How much mammalian meat and dairy does the patient eat?

In a cross-sectional survey of 201 farmers and ranchers with a self-reported AGS diagnosis, Cross and colleagues found that respondents averaged nearly 3 provider visits before diagnosis.

 The respondents came from 26 states, with most from Missouri and Oklahoma.

Investigators identified 4 distinct symptom clusters.

 The most reported symptoms included abdominal cramping, diarrhea, itchy skin, and nausea. Women reported more gastrointestinal discomfort, and men were more likely to fall into the mild symptom group. More than half (53.2%) were not familiar with AGS before their diagnosis, though most knew ticks could cause a food allergy (68.2%).

In a 2022 nationwide CDC survey of 1,500 health care providers, 42% had never heard of AGS. Another 35% were not confident in their ability to diagnose or manage the condition.

The gap extends to gastroenterologists, who are often the first specialists these patients see. When HCPLive approached 2 gastroenterologists at the American College of Gastroenterology (ACG) 2026 meeting in Nashville, both declined to discuss AGS, saying they did not know enough about it.

“It's a lot more recognizable [now],” said Chirag Patel, MD, an allergist and immunologist from Hackensack Meridian Health. “If I mentioned it 5 years ago, [my peers would be] like, ‘What are you talking about?’ But now, everyone that I talk to in the clinical world…definitely knows something about alpha-gal. They may not know exactly what it is, but they know something about it.”

Lone Star Tick Spread and Alpha-Gal Syndrome Reporting

Arkansas, Delaware, Iowa, Kentucky, Nebraska, New Jersey, North Dakota, South Carolina, Tennessee, Virginia, West Virginia, Massachusetts, Oklahoma, and Missouri.

Patel believes the tick’s spread into the Northeast plays a role in why more people know about AGS in recent years. Large news organizations have reported the uptick, including The New York Times.

The lone star tick was once found mainly in the South, but as temperatures have warmed, its range has pushed north. It is now common in coastal areas, including New Jersey and Long Island.

Many states are now requiring reporting of AGS, including Arkansas, Delaware, Iowa, Kentucky, Nebraska, New Jersey, North Dakota, South Carolina, Tennessee, Virginia, West Virginia, Massachusetts, Oklahoma (as of November 1, 2026), and Missouri.

 New York City, but not New York state, also has mandatory AGS reporting. States with voluntary AGS reporting include Kansas, Louisiana, Minnesota, Pennsylvania, Rhode Island, and Wisconsin.

Missouri’s law, signed this summer, requires laboratories to report positive alpha-gal test results to the state’s Department of Health and Senior Services, which will follow up to identify true cases.

Better data will show which communities are most affected and where clinicians need training, he added.

“I think many of us believe that [estimate] is probably a significant undercount,” said Benjamin W. Casterline, MD, PhD, an assistant professor of dermatology at the University of Missouri School of Medicine, in an interview with 

 “There are many more people affected than that.”

He noted that case counts can also shape federal policy. When data show a condition affects a significant number of Americans, initiatives such as allergen labeling tend to be more successful, he said.

On February 10, 2025, Rep. Jeff Van Drew (R-NJ) reintroduced the Alpha-gal Allergen Inclusion Act (H.R. 1178), which would add galactose-alpha-1,3-galactose (alpha-gal) to the federal list of major food allergens.

 The bill was first introduced in August 2024 but died at the end of that congressional session. If it passes, foods containing alpha-gal would have to disclose it on their labels, as is already required for allergens like peanuts and milk. As of October 2026, the bill remains in the House Energy and Commerce Committee, where it was referred shortly after its reintroduction.

The alpha-gal sugar molecule is found in most non-primate mammals, including cows, pigs, sheep, deer, and bison.

A bite from a lone star tick can sensitize a person to this molecule, after which they may react to red meat, dairy products, or products containing gelatin.Safe foods for individuals with AGS include poultry, seafood, eggs, fruits, and vegetables.

AGS symptoms include hives, swelling, wheezing, cramping, abdominal pain, diarrhea, and nausea. Patients may have skin symptoms, GI symptoms, or both.

Alpha-Gal Syndrome Risk in Farmers, Ranchers, and Outdoor Workers

Outdoor workers face particular risk. Because their jobs put them in tick habitat, they are more likely to be bitten repeatedly, Cross said.

Evidence also suggests black-legged ticks can cause AGS.

Cross stressed the importance of being aware of AGS, especially if the clinician treats farmers or ranchers.

“Historically, farmers and ranchers are pretty good about pushing through [symptoms],” Cross said. “What would be really important here for physicians is thinking about the fact that there can be a wide range of things, and that alpha-gal syndrome is something that’s here.”

He said clinicians treating farmers and ranchers need to look beyond what these patients eat. For rural workers, alpha-gal exposure can come from the job itself, including handling animals, deworming cattle, contact with amniotic fluid during birthing, and fumes. When taking a history, clinicians should ask when the symptoms appear, he said. Itching around animals or anaphylaxis during calving could point to AGS.

Cross noted that because specialists are scarce in rural areas, general practitioners and nurses often make the diagnosis, so they need AGS education rather than defaulting to a specialist referral.

Recognizing Delayed Alpha-Gal Syndrome Reactions

Alpha-Gal Syndrome: Closing an Underrecognized Allergy Diagnostic Gap

When it comes to AGS, Patel believes clinicians should think “outside the box.” Patients with AGS often have scattered symptoms, such as intermittent abdominal pain or random hives, that are easy to mistake for viral or chronic spontaneous urticaria, Patel said. The key is asking when reactions occur. Alpha-gal reactions are typically delayed and often strike in the evening or overnight, while chronic spontaneous urticaria can flare at any time.

“Symptoms are quite variable, and they don't happen every time,” Casterline said

 “So, someone who gets sick from a hamburger one night might not make them sick the next night for reasons that we don't understand.”

For patients without symptoms, Patel said test results need careful interpretation, since food allergy testing has roughly a 50% false-positive rate and serves as a risk assessment tool, not a diagnosis. A higher alpha-gal IgE level means a higher probability of true allergy, not a more severe one, he said. Even though lab reports may label results as “moderately” or “highly” allergic, a patient either is allergic or isn’t.

“It's not a test of alpha-gal syndrome. It's a test of the alpha-gal sensitization,” Casterline said.

AGS can only be diagnosed clinically based on symptoms after exposure. Severity is just as hard to predict, Casterline added. Patients with barely detectable antibody levels can have dangerous reactions, and some with very high levels have mild symptoms or none at all.

Managing Alpha-Gal Syndrome with the Alpha-Gal Ladder

Patel uses an “alpha-gal ladder” to counsel patients. Mammalian meats and fatty mammalian products sit at the top because alpha-gal concentrates in fat. That concentration also helps explain the delayed reaction, since fat takes longer to digest. Dairy comes next, followed by gelatin and medications. Patients who tolerate dairy can generally take vaccines, tablets, and gelatin capsules without serious concern, unless a medication contains large amounts of alpha-gal, he said. As patients’ IgE levels decline, he gradually reintroduces mammalian products into their diets.

Unlike protein allergies such as peanut, which rarely resolve after early childhood, AGS can fade over time because the immune system doesn’t form lasting memory against carbohydrates, Patel said. As long as patients avoid new tick bites, their alpha-gal IgE levels typically decline. Once they drop low enough, patients may be candidates for an oral challenge or gradual reintroduction of mammalian meat.

“Because people are now more aware of the tick bites, they’re making sure they're wearing long-sleeve clothes when they're going gardening or out in the woods,” Patel said.

Would Alpha-Gal Allergen Labeling Help Patients?

Patel said alpha-gal labeling would help patients but would be hard to implement. Alpha-gal content varies with the cut and fat content of meat, which is why reactions don’t happen every time a patient eats it, and even allergists struggle to quantify how much a given product contains.

“But I think if they can figure out how much alpha-gal is in a certain product and … what the threshold for tolerance is, that would certainly help the patients know that, ‘Okay, I can tolerate this, but not that much,”’ Patel said.

For Casterline, the case for labeling comes down to the toll of uncertainty. Patients spend a lot of time scrutinizing ingredients, unsure whether something like “natural flavor” comes from a mammalian source, and that worry affects their mental health, quality of life, and ability to work or attend school.

“Having clear labeling [of] what could have a mammalian alpha-gal versus what doesn't…would relieve a lot of stress off people and improve patient safety as well,” Casterline said.

Until better data, labeling, and treatments arrive, Patel said awareness remains clinicians’ most important tool. He cautioned that not every symptom a patient attributes to AGS is caused by it. Unexplained reactions should still raise suspicion.

“If you have random reactions that have features of an IgE-mediated reaction, then you should probably consider alpha-gal as part of your differential,” Patel said.

Alpha-Gal Syndrome. Alpha-gal Information. Accessed October 15, 2026. 

State-Level Initiatives. Alpha-Gal Alliance Action Fund. Accessed October 14, 2026.

https://alphagalaction.org/state-level-initiatives/

Commins SP. Diagnosis & management of alpha-gal syndrome: lessons from 2,500 patients. 

Welch AM, Beseler CL, Cross ST. Alpha-Gal Syndrome Symptom Profiles and Diagnostic Experiences Among Farmers and Ranchers. 

Health Care Provider Knowledge Regarding Alpha-gal Syndrome — United States, March–May 2022. CDC. Published July 28, 2023. Accessed October 14, 2026. 

https://www.cdc.gov/mmwr/volumes/72/wr/mm7230a1.htm

Astor M. How to Protect Yourself From Alpha-Gal Syndrome. The New York Times. Published July 15, 2026. Accessed October 14, 2026. 

Alpha-gal syndrome is reaching new regions, but delayed reactions and GI-only symptoms can leave patients undiagnosed for months or years.

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