Attack on food allergies: How technology can alleviate the path to new treatments without pain

According to the World Health Organization, food allergies can affect 220 million people worldwide. According to the nonprofit Food Allergy Research and Education (FARE), 13 children are suffering from life-threatening food allergies in the United States alone. In 2024, the U.S. Food and Drug Administration approved the first biology to treat food allergy after an unexpected exposure, and Xolair (Omalizumab) approved the first biology to treat food allergy, reaching a major milestone in this field. Although there are a few other food allergy therapies in the development pipeline, IThe combination of monoclonal antibodies and NCLUDE for immune-promoting drugs, innovation in this field remains limited.

Replace outdated harmful methods

One limitation of the development of new therapies that hinder the development of food allergies is that many commonly used research tools are outdated and often impractical. Research has been hampered by several factors, most notably by the tedious process of introducing potential allergens to determine the reaction. When experimental treatment reaches clinical trials, the most commonly used method to test patient efficacy is the Oral Food Challenge (OFC), which involves exposing patients to gradual amounts of food to determine whether they are responding.

This approach is often inconclusive, or worse yet, it may lead to an allergic reaction in some participants. The pressure of potential reactions during the Oral Food Challenge, coupled with the pressure of going to a medical facility for testing, may prevent many people from participating in research trials. It is also unlikely that parents will agree to intentionally expose their children to potential food allergens. One study found that 23% of children who received oral food challenges experienced multiple systemic reactions, with 15% of cases requiring adrenaline.

Meanwhile, one of the most promising methods for progressing in vitro food-alleviation testing is the basophil activation test (BAT), which uses flow cytometry to measure the activation of basophils (a type of white blood cell) in blood samples exposed to allergens. The challenge here is that bat assays are complex multi-step workflows that require expertise and rely on fresh blood samples that can be difficult to collect, store, and transport.

A recent study shows how new technologies can address these issues to investigate new therapies for food allergies. Team led by Icahn Medical School

Mount Sinai, New York, shows how a bat workflow that combines ready-made reagents with automation and artificial intelligence can simplify analysis. This emerging technology may allow researchers around the world to conduct previously unsuccessful food allergy studies because they lack the proper equipment or expertise. In the future, the same technology can greatly simplify the diagnosis of people's food allergies.

Simplify the workflow of flow cytometry

BAT allows researchers to capture characteristics unique to individual patients from blood draws, including specific allergic pathways in cells that are activated for certain foods. However, to effectively inquire about the function of these cellular pathways, laboratories require flow cytometry expertise and a continuous supply of fresh blood samples. A typical workflow for food allergy studies involves at least 10 manual moving steps and one or two centrifugal steps. Logically, this is not feasible for many labs.

In a recent study, researchers from 15 clinical sites in the United States collected 241 blood samples from children aged 1 to 3 years old. Instead of not having to rush the samples into the BAT assay, researchers at the collection site mixed the blood with the dry agent delivered to them in ready-made tubes. To measure the response to allergens and drugs for treating allergic diseases, some of these test tubes also contain an increasing number of dried peanut extracts or other reagents, achieving negative and positive controls. Despite the different compositions, all test tubes can be processed in the exact same way, significantly simplifying the experimental protocol.

The new process adopted for this study was established for ease, efficiency and accuracy. Since the reagents are dried and pre-packaged, clinical collection sites can be used with them at room temperature and then sent back to the central processing site without worrying about retaining their freshness. The 10-step shift process that is usually required is reduced to four steps without centrifugation. There are fewer manual steps, the chance of turning into errors, while reducing the risk that variability in manual processing may negatively affect the outcome.

The researchers compared the data they collected from the simplified BAT workflow to a double-blind placebo-controlled challenge study involving peanut exposure. They report that the BAT data accurately predicted the outcome of the food challenge.

Future opportunities

Streamlined bat testing can open up new research avenues for new ways to treat food allergies. In this study, 241 patient samples were divided into two groups, one for training machine learning algorithms and the other for testing them. Similar processes can be used to improve the characterization of food allergies.

Most food allergies experts believe that there is no single biomarker sufficient to fully elucidate how allergens touch people’s dangerous responses. Instead, there may be many different biomarkers at work – AI can be used to gain insights into those that can be used to define new targets for treatment. The advantage of artificial intelligence is that it simplifies the task of biomarkers identified and studied in a range of clinical trials and gains insights from them that can quickly lead to new therapeutic ideas.

In clinical trials of new therapies, wider use of bat tests may also help replace OFC. OFC testing can be a logistical hassle, especially if the patient is a child. Exposure to children with problematic food can cause moral problems and it is still difficult to determine how the child feels after exposure and treatment anyway. The simplified bat process can be measured by a simple blood test.

There are also sustainability advantages. During the study in Mount Sinai, the study did not require storing blood samples in the refrigerator, nor did it use dry ice to transport it to a central laboratory where it was processed, which was formulated to remain stable at room temperature. Without cold storage, it is easy to imagine how food allergy studies can be greatly expanded to include small remote clinical research centers and locations with potentially limited refrigeration capacity.

In the future, it may be possible to apply new bat technology to clinical use, thereby simplifying the process of identifying and diagnosing patients with food allergies.

With the continuous advancement of flow cytometry technology, our ability to discover new insights and therapeutic targets in food allergy will also be promoted and bring innovation to the market, which can enhance diagnosis and treatment of patients around the world.

Photo: Flickr user Blakespot

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