Predicting Immunotherapy Response via Cell Distribution Analysis
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Solution Overview
Problem
Current immunotherapies, such as checkpoint inhibitors, are ineffective in a significant proportion of patients, cause significant side effects, and are costly, necessitating a method to predict which patients are likely to respond to reduce side effects and costs in non-responders.
Innovation Solution
A method involving the use of a positive response control derived from a responder to determine the distribution of cells in a test sample based on biomarker expression, comparing it to a control to assess the likelihood of a clinical response, thereby identifying individuals likely to benefit from checkpoint inhibitor therapy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If immunomodulatory agents are administered to all patients, then more patients may potentially benefit from therapy, but side effects and costs increase significantly in non-responders
Solution Approach 1:
The patent applies preliminary action by performing flow cytometry analysis of immune cell markers before administering immunomodulatory therapy to identify patients likely to respond. This pre-screening approach allows clinicians to predict treatment outcomes in advance, administering therapy only to predicted responders, thereby preventing side effects in non-responders while maintaining therapeutic effectiveness for those who will benefit
2Reliability
If immunomodulatory agents are administered to all patients, then more patients may potentially benefit from therapy, but costs increase significantly in non-responders
Solution Approach 1:
The patent implements preliminary action through pre-treatment flow cytometry profiling that assesses immune cell populations and marker expression levels. This cost-effective diagnostic approach identifies predicted responders before expensive immunomodulatory therapy is administered, avoiding unnecessary treatment costs for non-responders while ensuring effective patients receive timely intervention
3Measurement precision
If flow cytometry analysis with multiple biomarkers is performed, then prediction accuracy improves, but device complexity and analysis time increase
Solution Approach 1:
The patent applies universality by using flow cytometry technology to simultaneously measure multiple immune cell markers (such as PD-1, CTLA-4, LAG-3 expression and various immune cell population levels) in a single integrated assay. This multi-functional approach allows comprehensive immune profiling with one instrument, achieving high prediction accuracy without proportionally increasing device complexity or operational burden
Data Source
AI summary
The invention relates to methods for determining the likelihood of the formation of a clinical response in an individual to therapy with an immunomodulatory agent for treatment of a disease or condition of the individual.