Immune Status Determination Kit Using Gene Expression Segmentation

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Solution Overview

Problem

Current methods for determining the immune status of individuals, particularly in septic shock patients, are inadequate due to heterogeneity among patients and the inability to accurately assess the immuno-inflammatory response, leading to ineffective therapies and potential harm from mismatched treatments.

Innovation Solution

A process and kit for determining in vitro immune status using specific reagents targeting various gene families, including markers, alarmins, inflammatory molecules, and chemokines, to assess the expression of target genes and correlate with reference expressions to establish the immune status, allowing for personalized and targeted therapies.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If current methods are used to determine immune status, then the process is simple, but the measurement precision is insufficient due to patient heterogeneity and inability to accurately assess immuno-inflammatory response

Engineering Contradiction:
Improveimmune status assessment accuracyVSAvoiddetermination process complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent segments the immune status assessment into multiple distinct gene families (markers, alarmins, inflammatory molecules, chemokines, regulatory molecules) and determines expression levels for each family separately. This segmentation allows for precise measurement of specific immune parameters while maintaining a systematic approach that manages complexity through structured organization of the determination process.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs a universal panel of reagents that can assess multiple aspects of immune status simultaneously through a single integrated process. The same basic methodology (gene expression determination) is applied across different gene families, allowing one system to perform multiple assessment functions and providing comprehensive immune status evaluation without requiring separate specialized tests for each parameter.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Reliability

If targeted therapies are implemented based on immune status, then treatment effectiveness improves, but the device complexity increases due to need for multiple specific reagents

Engineering Contradiction:
Improvetherapy effectivenessVSAvoidkit composition complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The kit is organized into distinct reagent sets targeting specific gene families (markers, alarmins, inflammatory molecules, chemokines, regulatory molecules). This segmentation allows clinicians to select and implement targeted therapies based on which specific gene family shows abnormal expression, enabling precise treatment matching while managing kit complexity through modular organization of reagents by functional category.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent monitors changes in gene expression parameters across different gene families to determine immune status. By establishing baseline expression levels and comparing against these references, the system can identify specific parameter deviations that guide therapy selection, allowing reliable targeted treatment decisions while using a standardized approach that manages overall system complexity.

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If comprehensive gene expression analysis is performed, then measurement precision improves, but the loss of time increases due to multiple determination steps

Engineering Contradiction:
Improveimmune status determination accuracyVSAvoiddetermination process time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent combines the determination of gene expression across multiple gene families into a single integrated process using a comprehensive reagent panel. By merging these assessments into one coordinated workflow rather than separate sequential tests, the system achieves comprehensive immune status evaluation with high measurement precision while minimizing the cumulative time loss that would result from multiple independent determination steps.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent establishes reference expression levels for multiple gene families in advance, allowing for rapid comparison and interpretation of patient samples. This preliminary preparation of reference data enables quick assessment of immune status without requiring time-consuming analysis protocols for each individual gene, thus maintaining high measurement precision while reducing the actual determination time for clinical samples.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS11180806B2Process and kit for determining in vitro the immune status of an individual
Publication Date: 2021.11.23 BIOMERIEUX SA
  • US11180806B2 patent drawing
  • US11180806B2 patent drawing
  • US11180806B2 patent drawing

AI summary

The present invention relates to a process for determining in vitro the immune status of an individual according to which: (a) a blood sample from the individual is provided, (b) at least two reagents specific to at least two products of expression of at least two target genes are provided; (c) the expression of said at least two target genes is determined, and (d) the expression of said at least two target genes respectively is compared with a reference expression, with a change in the expression of said at least two target genes relative to their reference expression indicating that the individual's immune status has changed, and a correlation between the expression of said at least two target genes with their reference expression indicating that the individual's immune status is normal; as well as a kit for determining said immune status of the individual.