Allergios®

by Allergios®  · Based in Netherlands → — We see allergy.
Allergy & Immunology Laboratory Medicine
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Overview

Allergios® is developing an innovative in-vitro allergy diagnostic system designed to provide clear and unambiguous allergy diagnoses, initially focusing on food allergies. The current methods for diagnosing allergies, particularly food allergies, are often cumbersome, risky for patients (e.g., oral food challenges), and complex for medical professionals, leading to delayed or insufficient diagnoses.

The Allergios® solution is based on research from the University of Bremen and the Medical University of Vienna. It utilizes a method and system that directly visualizes the allergic response by analyzing the ability of immunological factors in patient blood to induce basophil degranulation in the presence of specific allergens. This approach aims to replace high-risk procedures like the food challenge test.

The system comprises a disposable microfluidic chip, an optical reader called GranulEye®, and AI-based analysis software. This integrated platform allows for safe and easy allergy testing using just a few drops of blood serum. By visually analyzing allergen-specific degranulation of basophil cells, Allergios® intends to enable clinicians to provide timely and effective treatment options based on a clear diagnosis.

Allergios® plans to initially target food allergies and then gradually expand its diagnostic capabilities to other IgE-mediated allergies. The company is currently focused on transforming its technology prototype into a fully validated diagnostic platform, supported by grant funding and seed financing, with a Series A round targeted for mid-2026.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Direct allergy diagnosis
  • In-vitro blood test
  • Visual analysis of allergic response
  • Basophil degranulation detection
  • Disposable microfluidic chip
  • Optical reader (GranulEyeu00ae)
  • AI-based analysis software
  • Focus on food allergies (initial)
  • Scalable diagnostic platform

Use Cases

  • Diagnosing food allergies
  • Replacing risky allergy challenge tests
  • Providing unambiguous allergy diagnoses
  • Enabling timely and effective allergy treatment planning

What Physicians Need to Know

LIS/LIMS Integration
Allergiosu00ae offers an effective and scalable in-vitro allergy diagnostic system that aims to integrate with existing LIS/LIMS platforms. The system captures images via standard mobile devices and automatically syncs structured results into the electronic health record to reduce manual data entry. Bidirectional interfaces can route orders and results automatically, eliminating manual data entry and reducing transcription errors. Such integrations support allergen panel management, visual layouts for plate-based assays, and dilution tracking and calculations.
Supported Assay Types
Allergiosu00ae focuses on in-vitro allergy diagnostics by visually analyzing how blood serum enables allergen-specific degranulation of basophil cells. It will initially focus on food allergies, aiming to replace the oral food challenge test, and then expand to other IgE-mediated allergies. This method directly diagnoses allergies by visualizing the allergic response. Other common allergy tests include skin prick tests, specific IgE blood tests (ELISA, fluorescent enzyme immunoassays), patch testing, and basophil activation tests (BAT).
Result Interpretation AI
Allergiosu00ae utilizes AI-based analysis software to interpret allergy tests. This AI-driven interpretation aims to reduce the subjectivity associated with manual measurements, such as those in skin prick testing, by analyzing captured images of allergy test panels and automatically interpreting reactions. This can lead to standardization and efficiency in a workflow that has historically relied on manual methods. AI-assisted readout methods have demonstrated notable accuracy, reduced inter- and intra-observer variability, and decreased readout time.
Instrument Interfaces
Allergiosu00ae uses a disposable microfluidic chip and an optical reader (GranulEyeu00ae) as part of its system. Modern LIS/LIMS systems are designed to interface with a wide range of laboratory instruments and automated systems, including immunoassay analyzers, to enable seamless data exchange and automate workflows.
Reference Range Intelligence
Allergiosu00ae aims to provide clear and unambiguous diagnoses. In general allergy diagnostics, interpreting results requires correlating them with clinical symptoms, environmental exposures, and patient history. Reference ranges for total IgE vary by age and region, and specific IgE test results are typically reported in classes or numerical values, with clinical relevance needing careful interpretation.
Turnaround Time Impact
Allergiosu00ae aims to enable clinicians to provide timely and effective treatment options. AI-assisted readout methods can significantly reduce readout time compared to manual measurements. Automation and advanced allergy tests in laboratories contribute to faster turnaround times. Efficient LIS/LIMS integrations can also cut hours from workflow by automating order routing and result delivery.
Physician Tip

When utilizing Allergiosu00ae, remember that while the AI provides objective interpretation, always integrate these results with the patient's comprehensive clinical history, physical examination, and other relevant diagnostic findings. The system's focus on basophil degranulation offers a direct visualization of allergic response, which can be particularly valuable for food allergies. Be mindful that even with advanced AI, a thorough understanding of the patient's symptoms and potential exposures remains paramount for accurate diagnosis and personalized treatment plans. The enhanced documentation and reduced subjectivity can improve efficiency, but clinical judgment is irreplaceable.

Allergiosu00ae is designed for integration into existing EHR ecosystems, facilitating automatic syncing of structured results and reducing manual data entry. This workflow integration is crucial for streamlining allergy testing processes in high-volume practices. Future integrations should focus on seamless bidirectional communication with various LIS/LIMS platforms, supporting diverse data formats (e.g., HL7, FHIR) to ensure comprehensive data flow from sample processing to reporting and billing. This will enhance overall laboratory efficiency and connectivity within the broader healthcare IT infrastructure.

Details

Category Lab & Diagnostics
Pricing Unknown — unknown
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status Unknown AI-estimated — unknown
Integrations
EHR Not specified
Specialties Allergy & Immunology, Laboratory Medicine

Social Proof

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Press & Coverage

Allergios
Prototype 2.0 in Development u2013 Strategic Update from Allergios
Allergios appointed Dr. Holger Engel as CEO in July 2025 to lead the development of GranulEyeu00ae Prototype 2.0, aiming for a robust, automatable, label-free Basophil Activation Test for routine clinical settings. The company is focusing on technical refinement and testing with clinical samples, with further updates expected in the coming months.
2025-08
Allergios
Allergios is awarded HealthHolland grant funding, recognition of the relevance of our innovative IVD test for food allergies.
Allergios announced in October 2024 that it was awarded HealthHolland grant funding for its innovative IVD test for food allergies, GranulEye. This funding supports a public-private partnership with Wageningen University & Research to validate the test.
2024-10
StartUs Insights
10 New Allergy Companies and Startups | StartUs Insights
Allergios, founded in 2020 in the Netherlands, is developing AllergenIQ, an AI-driven platform for precise and personalized allergy care. The platform uses machine learning to identify allergens, predict reactions, and offers real-time monitoring through the AllergyTracker app.
2024-07
AAAAI News Release
Food Allergy Diagnostics are Enhanced by Machine Learning and Deep Learning AI Models
New research presented at the 2026 AAAAI Annual Meeting indicates that machine learning and deep learning AI models significantly improve diagnostic accuracy for food allergies, showing up to a 40% improvement over existing clinical criteria. These AI models have the potential to enhance current diagnostic strategies and improve the standard of care.
2026-02
Frontiers in Allergy
Digital health in allergy care: current practices, evidence, and future prospects
This review explores the current applications and future prospects of digital health in allergy care, including telemedicine, mobile health, and AI-based decision support systems. It highlights how these tools can enhance patient education, symptom monitoring, and personalized diagnostic and therapeutic strategies.
2026-07
YouTube (FDA)
FDA's Public Meeting on Food Allergen Thresholds - 02/18/2026
The FDA hosted a virtual public meeting on February 18, 2026, to discuss food allergen thresholds and their potential applications in the United States. This meeting, in collaboration with various stakeholders, aims to inform the FDA's approach to food allergen management and public health.
2026-02
PR Newswire
Children's Hospital Colorado Expands Food Allergy Treatment Options with Launch of Sublingual Immunotherapy Program
Children's Hospital Colorado launched its Sublingual Immunotherapy Program on September 1, 2026, expanding treatment options for children with certain food allergies. The program offers daily liquid drops to build tolerance to up to 10 food allergens.
2026-09
Allergy Therapeutics PLC
Regulatory news | Allergy Therapeutics PLC
Allergy Therapeutics PLC provides a list of regulatory news, including a trading update for the year ended June 30, 2026, and an announcement of positive biomarker results from their PROTECT Trial in March 2026.
2026-07

Videos

Product demos, reviews, and walkthroughs for Allergios®.

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Frequently Asked Questions

Allergiosu00ae is a diagnostic platform that utilizes a disposable microfluidic chip, an optical reader (GranulEyeu00ae), and AI-based analysis software to perform allergy tests. It aims to provide timely and effective treatment options based on a clear diagnosis, initially focusing on food allergies to potentially replace the food challenge test, and then expanding to other IgE-mediated allergies. Traditional methods include skin prick tests, intradermal tests, and IgE blood tests, all of which have varying accuracies and methodologies.
While the specific limitations of Allergiosu00ae are not fully detailed, general allergy tests are not 100% accurate and can have false positives or negatives. Factors like medications (e.g., antihistamines), skin conditions, recent illnesses, and the clinician's skill can influence test accuracy. It's crucial to interpret test results in conjunction with a patient's detailed medical history and symptoms.
Allergiosu00ae is currently focused on transforming its technology prototype into a fully validated diagnostic platform, building on grant funding and targeting a Series A funding round. In general, diagnostic companies must ensure their business models and processes comply with federal and state guidelines, often involving legal and medical management review. Proper documentation, staff training, and adherence to established practice parameters are crucial for compliance in allergy testing.
Alternatives to Allergiosu00ae include skin prick tests, intradermal tests, and specific IgE blood tests (e.g., ImmunoCAP). Skin prick tests are common for environmental and some food allergies, providing quick results. Intradermal tests are more sensitive and used when skin prick tests are negative but suspicion remains high. Blood tests are preferred for patients on certain medications, with skin conditions, or when a wider range of allergens needs to be tested. Oral food challenges are also used, particularly for food allergies, but require strict supervision due to the risk of severe reactions.
Specific pricing for Allergiosu00ae is not publicly available as of the current information. However, general allergy testing costs vary significantly. Skin allergy tests can range from $60 to $300, while blood allergy tests typically cost between $200 and $1,000, not including office visit fees. Direct-pay options for blood panels can be found for $129-$319, with total IgE tests starting around $39. The overall cost can depend on deductibles, co-pays, co-insurance, and whether the provider is in-network.
While specific training for Allergiosu00ae is not detailed, for general allergy testing, proper training for medical staff is essential. Turnkey allergy programs often provide training for nurses or medical assistants to administer tests. Direct or personal physician supervision is often required for allergy tests due to the potential for anaphylactic reactions. Interpretation of results, especially for food allergies, often requires the expertise of a board-certified allergist due to the complexities of false positives and predictive values.
The specific accuracy and false positive/negative rates for Allergiosu00ae are not yet publicly available, as the company is still in the process of validating its diagnostic platform. However, for allergy tests in general, false positives are common, with blood tests having a false positive rate of about 50% and skin prick tests around 50-60%. False negatives are rare for skin prick tests. Accurate diagnosis relies on correlating test results with the patient's clinical history.

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Suggest an Edit → | Last Verified: 2026-09-11 | First Added: 2026-09-11
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