HER2 Inhibitor Resistance Diagnostic Kit Using Gene Expression Markers

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Solution Overview

Problem

Current biomarkers and diagnostic kits for determining HER2 inhibitor resistance in cancer patients lack reliability, leading to overtreatment and increased medical expenses due to the prescription of unnecessary drugs, as there is no commercially available product that effectively assesses resistance to HER2 inhibitors like Herceptin.

Innovation Solution

A diagnostic marker and kit that measure the expression levels of specific genes associated with HER2 inhibitor resistance, such as ATF4, CHEK2, EGF, EGLN2, ENAH, FARP2, and RAD51, using mRNA or protein expression analysis to determine resistance, thereby allowing for the prescription of second-line drugs and minimizing side effects and costs.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If current biomarkers and diagnostic kits are used to determine HER2 inhibitor resistance, then diagnosis can be performed, but the reliability of resistance determination is low leading to overtreatment

Engineering Contradiction:
Improvereliability of resistance determinationVSAvoidavailability of diagnostic products
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent changes the diagnostic parameters by identifying and measuring specific genes (ATF4, CHEK2, EGF, EGLN2, ENAH, FARP2, RAD51) whose expression levels correlate with HER2 inhibitor resistance. This parameter change enables reliable resistance determination through quantifying mRNA or protein expression of these specific genes, thereby resolving the contradiction between reliability and product availability.

Inventive Principle:
Principle #35Parameter changes

2Productivity

If HER2 inhibitors are prescribed to all HER2-positive cancer patients, then treatment coverage is maximized, but unnecessary drugs are prescribed leading to increased medical expenses and side effects

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidside effects and medical expenses
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary action by performing resistance determination diagnosis before prescribing HER2 inhibitors. By measuring the expression levels of resistance-related genes (ATF4, CHEK2, EGF, EGLN2, ENAH, FARP2, RAD51) in advance, the system identifies patients who will respond to treatment versus those who will not, preventing unnecessary drug administration and its associated side effects and costs.

Inventive Principle:
Principle #10Preliminary action

3Ease of operation

If first-line drug therapy is prescribed to all cancer patients, then standard treatment protocol is followed, but alternative therapy is required when patients do not respond

Engineering Contradiction:
Improvestandard treatment protocolVSAvoidtime to effective treatment
Core Design Contradiction:
Ease of operationVSLoss of time

Solution Approach 1:

The patent performs preliminary resistance determination before initiating first-line HER2 inhibitor therapy by measuring gene expression levels of resistance markers (ATF4, CHEK2, EGF, EGLN2, ENAH, FARP2, RAD51). This preliminary action identifies suitable candidates for HER2 inhibitor treatment, ensuring that patients who will not respond are identified beforehand, thus avoiding time loss from ineffective treatment and enabling timely alternative therapy selection.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS10190170B2Maker for diagnosing HER2 inhibitor resistant cancer, diagnostic kit comprising same, and method for diagnosing HER2 inhibitor resistant cancer
Publication Date: 2019.01.29 NATIONAL CANCER CENTER(JP)
  • US10190170B2 patent drawing
  • US10190170B2 patent drawing
  • US10190170B2 patent drawing

AI summary

The present invention relates to a composition for detecting a marker for diagnosing an HER2 inhibitor-resistant cancer, a diagnostic kit including same, and a method for detecting the marker. More particularly, the present invention relates to a composition for detecting a maker for diagnosing an HER2 inhibitor-resistant cancer, a diagnostic kit including same, and a method for detecting the marker, wherein the present invention allows presence and absence of resistance to an HER2 inhibitor, which is typically prescribed to an HER2-positive cancer patient, in an HER2-positive cancer patient to be determined in an easier manner with remarkably high reliability.