Soluble CLEC-2 Ratio Biomarker for Platelet Activation Assessment

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Solution Overview

Problem

Existing methods for measuring platelet activation, such as using PF4, β-thromboglobulin, and membrane glycoproteins, are unreliable due to non-specific release during blood collection and lack clinical significance, while soluble CLEC-2 alone does not accurately reflect platelet activation status due to correlation with platelet count variations.

Innovation Solution

Measure the concentration of soluble CLEC-2 and platelet count, calculate the ratio [soluble CLEC-2 concentration]/[platelet count], and compare it with healthy individuals to accurately assess platelet activation and thrombotic hemostatic diseases.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If soluble CLEC-2 concentration is used as a platelet activation marker, then platelet activation can be detected, but the measurement is affected by platelet count variations leading to inaccurate assessment

Engineering Contradiction:
Improveplatelet activation assessment accuracyVSAvoidmeasurement reliability
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The invention changes the measurement parameter from absolute soluble CLEC-2 concentration to a normalized ratio (soluble CLEC-2 concentration/platelet count). This parameter transformation eliminates the confounding effect of platelet count variations, allowing accurate assessment of platelet activation independent of platelet number changes.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If conventional markers like PF4 or β-thromboglobulin are used, then platelet activation can be detected, but complicated blood collection procedures are required

Engineering Contradiction:
Improveplatelet activation detectionVSAvoidblood collection procedure
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The invention extracts and utilizes soluble CLEC-2, a marker that is naturally released into plasma during platelet activation, unlike granule contents that require special handling. This extraction of a suitable biomarker enables detection of platelet activation using routine blood collection procedures without requiring specialized tubes or immediate processing.

Inventive Principle:
Principle #2Taking out (Extraction)

3Measurement precision

If membrane glycoproteins like GPIba or GPVI are used as markers, then platelet activation can be detected, but clinical significance is unclear due to ligand-dependent release

Engineering Contradiction:
Improveplatelet activation detectionVSAvoidclinical significance
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The invention utilizes soluble CLEC-2, a stable protein marker released during platelet activation, replacing unstable or ligand-dependent markers like cleaved membrane glycoproteins. This disposable-like approach uses a robust, easily measurable marker that provides reliable clinical information without the complexities of ligand-dependent release mechanisms.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Data Source

PatentUS12590978B2Method for measuring platelet activation based on soluble CLEC-2 and platelet count
Publication Date: 2026.03.31 PHC CORP
  • US12590978B2 patent drawing
  • US12590978B2 patent drawing
  • US12590978B2 patent drawing

AI summary

Provided is a method for assisting in grasping the status of platelet activation, by developing a biomarker that more accurately reflects platelet activation in vivo, said method being usable in testing for thrombotic hemostatic diseases. The method for assisting in grasping the status of platelet activation comprises (1) measuring the concentration of soluble CLEC-2 and a platelet count in a sample obtained from a subject, and (2) calculating a value of [soluble CLEC-2 concentration]/[platelet count] by dividing the soluble CLEC-2 concentration by the platelet count. If desired, the method may further comprise (3) comparing the value with a value of [soluble CLEC-2 concentration]/[platelet count] obtained by using samples from healthy persons.