Combined Positive Score for Accurate Anti-PD Therapy Eligibility
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Solution Overview
Problem
Current scoring methods for PD-L1 expression on tumor and non-tumor cells are impractical and lead to confusion, doubling the pathologist's workload and potentially misidentifying patients eligible for anti-PD therapy.
Innovation Solution
A Combined Positive Score (CPS) method is introduced, calculating the number of viable PD-L1 positive tumor cells, viable PD-L1 negative tumor cells, and viable PD-L1 positive mononuclear inflammatory cells, using the formula CPS = (PD-L1 positive tumor cells + PD-L1 positive MIC) / (PD-L1 positive tumor cells + PD-L1 negative tumor cells) × 100%, with eligibility for anti-PD therapy determined by a threshold score.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If current scoring methods are used to evaluate PD-L1 expression on both tumor and non-tumor cells, then comprehensive assessment is achieved, but pathologist workload doubles and measurement precision deteriorates due to confusion
Solution Approach 1:
The scoring method segments the evaluation into distinct cell type categories (tumor cells and non-tumor cells) and applies different scoring criteria to each. This segmentation allows pathologists to systematically assess PD-L1 expression without confusion, improving measurement precision while managing workload through structured evaluation protocols.
Solution Approach 2:
The method applies local quality by recognizing that different cell types (tumor versus non-tumor) have different PD-L1 expression patterns and scoring requirements. By tailoring the assessment criteria to the specific cell type being evaluated, the system achieves accurate PD-L1 expression measurement without requiring pathologists to simultaneously manage multiple scoring systems.
2Measurement precision
If separate scoring criteria are applied to tumor and non-tumor cells, then measurement precision improves, but device complexity increases
Solution Approach 1:
The scoring system merges the evaluation of PD-L1 expression on both tumor and non-tumor cells into a unified framework. By combining these assessments while maintaining distinct criteria for each cell type, the system achieves high measurement precision without requiring completely separate evaluation protocols, thus managing overall system complexity.
3Reliability
If comprehensive PD-L1 scoring is performed on all cells, then reliability of patient eligibility assessment improves, but time consumption increases
Solution Approach 1:
The scoring method performs preliminary classification of cell types before applying PD-L1 expression scoring. By first identifying whether cells are tumor or non-tumor cells and then applying the appropriate scoring criteria, the system ensures reliable patient eligibility assessment while reducing time consumption through a systematic, stepwise approach that avoids redundant evaluations.
Data Source
AI summary
Aspects of the present disclosure provide methods for determining the eligibility of a subject having a malignancy for treatment with an anti-PD therapeutic agent based on a Combined Positive Score (CPS) for a tumor tissue sample from the subject. Compositions and kits or performing the disclosed methods are also provided.