Immune Competence Blood Test for Tumor Status
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Solution Overview
Problem
Current methods fail to effectively assess and predict the responsiveness of cancer to immunotherapy, leading to inadequate treatment outcomes due to compromised immune function and chronic inflammation, particularly in the context of cancer growth and standard therapies.
Innovation Solution
A novel immune competence blood test that involves contacting a patient sample with an innate immune agonist and measuring cytokine levels, such as TNF-α and IL-12, to determine immune proficiency and predict responsiveness to immunotherapy, including oncolytic viral therapy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If current methods are used to assess immune function, then treatment decisions can be made, but the assessment is inadequate and fails to predict responsiveness to immunotherapy accurately
Solution Approach 1:
The patent performs preliminary assessment of innate immune competence in peripheral blood before initiating immunotherapy. By measuring baseline immune function through cytokine response to agonists (TLR agonists, STING agonists, oncolytic viruses) before treatment, the system predicts future therapeutic responsiveness, allowing clinicians to pre-identify suitable candidates and avoid ineffective treatments.
Solution Approach 2:
The patent implements feedback by measuring cytokine levels (TNF-α, IL-12, IFN-β) as indicators of immune competence and using these measurements to adjust treatment decisions. The system continuously monitors immune response markers to determine whether a patient is responding to immunotherapy and whether treatment should be continued, modified, or discontinued.
2Measurement precision
If invasive tumor biopsies are performed to assess tumor immune status, then accurate tumor immune function can be measured, but patient discomfort and procedural complexity increase
Solution Approach 1:
The patent uses peripheral blood as an intermediary surrogate for directly measuring tumor immune status. Since immune cells traffic between the periphery and tumor, measuring immune competence in accessible peripheral blood provides indirect but accurate information about tumor immune function, avoiding the need for invasive tumor biopsies while maintaining measurement validity.
Solution Approach 2:
The patent creates a copy of the tumor immune assessment problem by measuring equivalent immune parameters in peripheral blood rather than directly in the tumor. The immune competence of blood-derived cells reflects the functional state of tumor-infiltrating cells, providing a non-invasive proxy measurement that correlates with tumor immune status.
3Reliability
If comprehensive immune function testing is performed, then treatment responsiveness can be predicted, but test complexity and cost increase
Solution Approach 1:
The patent extracts and measures only the specific cytokine markers (TNF-α, IL-12, IFN-β) that are most predictive of immunotherapy responsiveness, rather than performing comprehensive immune profiling. By focusing on these key extractions from the complex immune system, the test achieves reliable prediction with reduced complexity compared to measuring all possible immune parameters.
Solution Approach 2:
The patent uses a universal testing approach where the same assay platform measures multiple cytokine markers simultaneously to assess different aspects of immune competence. The multi-functional assay can evaluate responses to different types of agonists (TLR, STING, oncolytic viruses) using a single integrated system, reducing overall test complexity while maintaining comprehensive assessment.
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 approach allows for a non-invasive and cost-effective method to identify patients likely to benefit from immunotherapies by correlating peripheral blood immune responses with tumor immune status, improving treatment outcomes and overall survival.
Implementation Method 1
measuring the levels of TNF-α and IL-12 produced by the sample
Data Source
AI summary
The present disclosure provides a method of measuring the production of a cytokine in a sample in response to an agonist to determine responsiveness of a patient to immunotherapy. The present disclosure also provides a method of treating a cancer patient with an oncolytic viral therapy when a sample from the patient has a certain level of anti-viral antibodies. Further, the present disclosure describes, in part, an immune competence blood test that allows for one skilled in the art to determine if a tumor is immunoproficient to respond to an immunotherapy.