Plasma microRNA biomarker panel for colorectal neoplasia detection

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Solution Overview

Problem

Current methods for detecting colorectal cancer lack sensitivity and invasiveness, with existing biomarkers failing to accurately diagnose early-stage colorectal neoplasia and cancer precursor lesions, necessitating the development of non-invasive and highly discriminative diagnostic tools.

Innovation Solution

The method involves measuring the overall expression pattern of specific microRNAs (miRNAs) in biological samples, such as plasma or tissue, comparing them to healthy controls, and using a combination of overexpressed and underexpressed miRNAs like miR19a, miR19b, miR15b, miR29a, and miR335 to diagnose colorectal neoplasia with high specificity and sensitivity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If current biomarker methods are used for colorectal cancer detection, then the diagnostic process is simpler, but the sensitivity and accuracy for early-stage detection is insufficient

Engineering Contradiction:
Improvedetection accuracyVSAvoidmethod complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The invention segments the diagnostic approach by dividing it into multiple sequential steps: (1) detecting plasma miRNA expression levels, (2) detecting colorectal cancer-specific biomarkers, and (3) integrating both results for comprehensive diagnosis. This segmentation allows each step to contribute specific information, thereby improving overall detection accuracy while maintaining a manageable procedural complexity through systematic organization.

Inventive Principle:
Principle #1Segmentation

2Reliability

If existing single biomarker methods are used, then the testing process is faster and simpler, but the ability to accurately diagnose early-stage colorectal neoplasia is limited

Engineering Contradiction:
Improvediagnostic reliabilityVSAvoidtesting complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention merges two distinct diagnostic approaches into a unified testing system: (1) plasma microRNA expression analysis and (2) colorectal cancer-specific biomarker detection. By combining these complementary methods, the invention achieves higher diagnostic reliability for early-stage neoplasia, as the synergistic information from both biomarker types overcomes the limitations of single-marker approaches while integrating them into a single comprehensive test.

Inventive Principle:
Principle #5Merging (Combining)

3Loss of information

If invasive diagnostic procedures are used, then more detailed information can be obtained, but patient discomfort and procedural complexity increase

Engineering Contradiction:
Improveinformation completenessVSAvoidpatient convenience
Core Design Contradiction:
Loss of informationVSEase of operation

Solution Approach 1:

The invention introduces plasma miRNA analysis as an intermediary, non-invasive screening layer before potentially more invasive diagnostic procedures. By first analyzing circulating miRNAs in plasma, the system can identify high-risk individuals who would benefit from further invasive testing, while sparing low-risk individuals from unnecessary invasive procedures. This intermediary approach preserves information completeness by maintaining a tiered diagnostic pathway while significantly improving patient convenience through the non-invasive nature of plasma sampling.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentUS20180355439A1Method of treating advanced colorectal adenoma
Publication Date: 2018.12.13 CENT DE INVESTIGACION BIOMEDICA & RED DE ENFERMEDADES HEPATICAS Y DIGESTIVAS CIBEREHD
  • US20180355439A1 patent drawing
  • US20180355439A1 patent drawing
  • US20180355439A1 patent drawing

AI summary

The present invention relates in general to the field of colorectal cancer detection, and more particularly, to plasma microRNAs for the detection of early colorectal cancer. Specifically, the present invention includes methods, kits and biomarkers for diagnosing or detecting colorectal neoplasia in a human subject comprising the steps of: A method for diagnosing or detecting colorectal neoplasia in a human subject comprising the steps of: obtaining one or more biological samples from the subject suspected of suffering from colorectal neoplasia; measuring an overall expression pattern or level of one or more microRNAs obtained from the one or more biological samples of the subject; and comparing the overall expression pattern of the one or more microRNAs from the biological sample of the subject suspected of suffering from colorectal neoplasia with the overall expression pattern of the one or more microRNAs from a biological sample of a normal subject, wherein the normal subject is a healthy subject not suffering from colorectal neoplasia, wherein overexpression of a combination of miR19a and miR19b, or miR19a and miR19b and miR15b is indicative of colorectal cancer.