PD-L1 Detection via EpCAM Capture Screen and Multicolor Fluorescence

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Solution Overview

Problem

Current methods for detecting PD-L1 on tumor cells, particularly circulating tumor cells, are invasive, inaccurate, and subject to high variability due to complex background cells and expert-dependent interpretation.

Innovation Solution

A novel method utilizing a capture screen with EpCAM antibodies to specifically capture tumor cells from body fluids, followed by incubation with PD-L1 antibodies and multicolor imaging analysis using DAPI, CK, and CD45 fluorescent antibodies to accurately identify CTCs with PD-L1 expression.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If immunohistochemical methods are used to detect PD-L1 on tumor tissues, then detection can be performed on tumor samples, but the results are closely related to pathologist experience and lack stability

Engineering Contradiction:
Improvedetection accuracyVSAvoidresult stability
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent replaces manual immunohistochemical staining and expert visual interpretation with automated flow cytometry technology. The system uses automated cell capture, staining, and analysis equipment to objectively detect PD-L1 expression, eliminating the subjectivity and experience-dependency of pathologist interpretation while maintaining detection accuracy.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent employs automated flow cytometry systems that perform cell capture, antibody staining, washing, and data analysis automatically without manual intervention. The system self-calibrates and processes samples consistently, ensuring reproducible results across different operators and laboratories, thereby improving result stability.

Inventive Principle:
Principle #25Self-service

2Quantity of substance

If whole blood is treated with red cell lysing solution to separate nucleated cells for PD-L1 detection, then nucleated cells can be obtained, but background cells become complex and detection accuracy is difficult to ensure

Engineering Contradiction:
Improvenucleated cell separationVSAvoiddetection accuracy
Core Design Contradiction:
Quantity of substanceVSMeasurement precision

Solution Approach 1:

The patent extracts and isolates circulating tumor cells (CTCs) from the complex blood background using automated capture technology. By specifically targeting CTCs through antibody-based capture and flow cytometry sorting, the system removes interfering background cells while preserving the target population, thereby improving detection accuracy.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent uses fluorescently labeled antibodies as intermediaries to specifically bind and identify CTCs. These antibodies serve as mediators that distinguish target cells from background cells based on surface marker expression, enabling accurate detection despite the complexity of the blood sample matrix.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Quantity of substance

If membrane filtering is used to obtain circulating tumor cells from peripheral blood, then CTCs can be separated, but additional HE staining and expert reading are required which are cumbersome and subjective

Engineering Contradiction:
ImproveCTC separationVSAvoiddetection process complexity
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The patent combines cell separation, staining, and detection into a single automated flow cytometry workflow. The system integrates multiple functions (filtration, immunostaining, fluorescence detection, and data analysis) into one continuous automated process, eliminating the need for separate HE staining and expert interpretation steps.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent uses fluorescent labeling with distinct emission wavelengths to automatically identify and characterize CTCs. Different fluorophores mark different cell surface markers, allowing the automated system to distinguish CTCs from background cells based on their fluorescence signature, replacing subjective visual assessment with objective optical detection.

Inventive Principle:
Principle #32Color changes

4Measurement precision

If expert reading is used to identify CTCs with PD-L1 expression, then accurate identification can be achieved, but strong subjectivity and professionalism requirements make it difficult to promote and use

Engineering Contradiction:
ImproveCTC identification accuracyVSAvoidmethod accessibility
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The patent replaces expert visual interpretation with automated flow cytometry analysis. The system uses computer-based algorithms to analyze fluorescence data, identify positive cells, and calculate PD-L1 expression levels automatically. This substitution maintains high identification accuracy while eliminating the need for expert pathology interpretation.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The automated system performs self-analysis of the stained cells, automatically gating populations, identifying positive cells based on fluorescence intensity thresholds, and generating quantitative results. This self-service capability eliminates dependency on expert operators, making the method accessible to laboratories without specialized pathology expertise.

Inventive Principle:
Principle #25Self-service

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 significantly improves detection accuracy and reliability by isolating tumor cells from background cells, reducing false positives, and simplifying the detection process, thereby enabling more precise identification of PD-L1 expression on CTCs.

Implementation Method 1

a capture screen with EpCAM antibodies to specifically capture tumor cells from body fluids

Methodology Applied
Scientific EffectAntibody-antigen binding:

Implementation Method 2

multicolor imaging analysis using DAPI, CK, and CD45 fluorescent antibodies

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Data Source

PatentEP3974835B1Method for detecting tumor cell surface marker molecule PD-l1
Publication Date: 2025.02.26 HEMOSMART MEDICAL TECH LTD
  • EP3974835B1 patent drawingFigure 1a~3b
  • EP3974835B1 patent drawingFigure 4a~5b

AI summary

Disclosed is a method for detecting a tumor cell surface marker molecule, PD-L1, which method comprises the following steps: A, providing a capture screen that comprises a mesh matrix body and an EpCAM antibody formed in the mesh matrix body by means of incubation; B, making nucleated cells separated from the body fluid flow through the capture screen, such that tumor cells in the nucleated cells bind to the capture screen; C, fixing the captured tumor cells on the capture screen by using formaldehyde; D, successively using a PD-L1 primary antibody solution, a PD-L1 secondary antibody solution labeled with a fluorophore AlexaFluor 647, a pan-CK-AlexaFluor 488 primary antibody solution, a CD45 primary antibody solution and a CD45 secondary antibody solution labeled with a fluorophore AlexaFluor 568, to incubate the cells fixed on the capture screen, and then labeling all the cells on the capture screen with a nuclear fluorescent dye. Compared with existing methods, the detection method of the present invention can improve detection accuracy and is easier in terms of operation.