Allergen-Specific IgE Diagnostic Assay for Immunotherapy Safety
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Solution Overview
Problem
Current treatments for allergies, particularly allergen-specific immunotherapy, are inadequate as they are costly, impractical, and carry significant risks, with no quantitative tests available to assess safety, efficacy, or outcome during treatment.
Innovation Solution
A method involving the extraction of allergen-specific IgE from patient samples, mixing it with specific antibodies or antigen binding fragments, and using an in vivo allergen-specific non-human animal model to determine responsiveness, employing human monoclonal antibodies that block allergen-specific IgE binding to assess therapeutic response.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If allergen-specific immunotherapy is administered to treat allergies, then the progression of allergies is modified and therapeutic efficacy is improved, but severe adverse events such as anaphylaxis occur and safety deteriorates
Solution Approach 1:
The patent introduces a diagnostic test as an intermediary tool that assesses patient responsiveness to immunotherapy before and during treatment. This mediator enables safer treatment by identifying patients who are likely to respond well, thereby reducing the risk of severe adverse events while maintaining therapeutic efficacy.
Solution Approach 2:
The patent applies preliminary action by performing diagnostic assessments before initiating immunotherapy and at intervals during treatment. This advance evaluation identifies suitable candidates and monitors treatment progress, allowing clinicians to prevent or manage severe adverse events before they occur by adjusting treatment based on predicted responsiveness.
2Ease of operation
If traditional allergy treatments such as avoidance and medications are used, then immediate symptom relief is achieved, but the progression of allergies continues and long-term efficacy deteriorates
Solution Approach 1:
The patent implements feedback mechanisms through diagnostic tests that measure patient responsiveness to immunotherapy. This feedback loop allows clinicians to monitor treatment progress and adjust immunotherapy regimens accordingly, ensuring long-term efficacy while managing short-term symptoms, thereby overcoming the limitations of traditional treatments that only provide symptomatic relief.
3Reliability
If allergen-specific immunotherapy is administered over 3 to 5 years, then disease modification is achieved, but treatment duration increases and patient burden worsens
Solution Approach 1:
The patent uses preliminary diagnostic assessment to identify patients with high likelihood of responding to immunotherapy. By selecting patients who are more likely to achieve disease modification, the required treatment duration can be optimized, potentially reducing the 3-5 year commitment while maintaining disease-modifying benefits.
Solution Approach 2:
The patent replaces the mechanical, time-intensive process of long-term immunotherapy administration with a more efficient diagnostic approach. By using biomarker-based assessment, the system can predict treatment outcomes and potentially shorten the treatment duration needed to achieve disease modification, reducing patient burden.
4Ease of operation
If no quantitative diagnostic tests are available for assessing immunotherapy, then treatment decisions are made without objective data, but the ability to determine safety and efficacy deteriorates
Solution Approach 1:
The patent replaces subjective, non-quantitative treatment decision-making with objective, biomarker-based measurement systems. This substitution introduces precise quantitative tests that measure patient responsiveness to immunotherapy, enabling accurate assessment of safety and efficacy while simplifying clinical decision-making through clear, data-driven criteria.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This method allows for the determination of a patient's responsiveness to therapy, providing insights into safety and efficacy, and potentially aiding in the initiation or termination of maintenance therapy, offering a safer and more effective alternative to traditional treatments.
Implementation Method 1
determining if the addition of the antibodies or antigen binding fragments thereof specific for the allergen blocks the binding of the allergen specific IgE from step (i) to the allergen
Data Source
Figure 1A~1B
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AI summary
The present invention provides in vitro and in vivo diagnostic tests and methods for determining the safety, efficacy, or outcome of allergen-specific immunotherapy (SIT) in a patient. The present invention also provides for the measurement of allergen specific IgG and IgE in a patient tissue sample, or extract thereof, or in a biological fluid or blood sample, and determining whether the allergen-specific immunoglobulins contained in the patient sample(s), upon injection into an allergen-sensitized animal, will protect the animal following challenge with the allergen. The invention also provides methods for determining whether a patient suffering from an allergy is responsive to therapy with one or more therapeutic antibodies specific for the allergen.