Platelet Function Biomarkers Gene Expression Analysis

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Solution Overview

Problem

Current methods for assessing platelet function and determining cardiovascular disease risk are limited by technical complexity, requiring specialized equipment and trained personnel, and are not readily available for point-of-care testing, making it difficult to identify individuals at risk for coronary artery disease and monitor antiplatelet therapy effectively.

Innovation Solution

A method involving the determination of gene expression levels of specific biomarkers such as ITGA2B and RUNX1 in biological samples to diagnose, predict, and monitor platelet function and cardiovascular disease risk, allowing for the administration of antiplatelet agents and adjustment of treatment regimens.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If platelet function assays are performed using specialized equipment and trained personnel, then measurement precision is improved, but device complexity and ease of operation worsen

Engineering Contradiction:
Improveplatelet function assessment accuracyVSAvoidtesting equipment complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces complex mechanical platelet function assays with a molecular biology-based gene expression analysis system. Instead of using specialized platelet aggregation equipment and trained personnel to perform mechanical assays, the invention uses RNA extraction and gene expression profiling (measuring transcripts like ITGA2B, ITGB3, and PF4) to assess platelet function. This substitution of mechanical testing with molecular analysis maintains measurement precision while eliminating the need for complex specialized equipment and extensive training.

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

2Productivity

If platelet function testing is performed at point-of-care within hours of phlebotomy, then productivity is improved, but device complexity worsens

Engineering Contradiction:
Improvetesting speedVSAvoidpoint-of-care equipment complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent replaces point-of-care mechanical platelet function testing with a molecular gene expression analysis that can be performed on stored biological samples. Instead of requiring immediate testing within hours of phlebotomy using complex point-of-care equipment, the invention extracts RNA from stored whole blood or plasma samples and performs gene expression profiling in a standard laboratory setting. This approach eliminates the time constraint while avoiding the need for complex point-of-care devices.

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

3Measurement precision

If genome-wide surveys are conducted to identify novel risk factors, then measurement precision is improved, but loss of time worsens

Engineering Contradiction:
Improverisk factor identification accuracyVSAvoidtesting duration
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent extracts and focuses on specific gene transcripts directly related to platelet function (ITGA2B, ITGB3, PF4, and other platelet-specific markers) from the broader genome-wide survey approach. Instead of conducting comprehensive genome-wide surveys that identify numerous loci with uncertain clinical relevance, the invention selectively measures a targeted panel of platelet function-related gene expression markers. This extraction of relevant markers from the broader genomic context maintains precision in identifying cardiovascular risk while dramatically reducing the time and resources required compared to full genome-wide surveys.

Inventive Principle:
Principle #2Taking out (Extraction)

Data Source

PatentUS11008619B2Diagnostic markers for platelet function and methods of use
Publication Date: 2021.05.18 DUKE UNIV
  • US11008619B2 patent drawing
  • US11008619B2 patent drawing
  • US11008619B2 patent drawing

AI summary

Disclosed herein are biomarkers of platelet function and methods for assessing platelet function in response to antiplatelet therapy and for determining a prognosis, diagnosis, or risk identification in a patient by detecting at least one biomarker of platelet function in the patient as well as determining amounts thereof. The biomarkers may be used to identify a patient as a candidate for treatment with an antiplatelet agent and to monitor and adjust antiplatelet therapy in a patient.