Blood miRNA Panel Detection for Lower-False-Positive Prostate Screening

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Solution Overview

Problem

Existing prostate cancer detection methods, particularly the PSA test, suffer from high false positive rates and low sensitivity, leading to overdiagnosis and overtreatment, and existing miRNA markers lack sufficient validation and specificity for reliable detection.

Innovation Solution

A kit and device utilizing nucleic acids that specifically bind to a set of identified miRNAs, including miR-4443, miR-1908-5p, miR-4257, and others, for detecting prostate cancer in blood samples, providing improved sensitivity and specificity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If PSA test is used for prostate cancer detection, then detection coverage is achieved, but false positive rate increases and sensitivity remains low

Engineering Contradiction:
Improvedetection accuracyVSAvoidsensitivity and false positive rate
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent segments the detection approach by using multiple specific miRNA markers (miR-4443, miR-1908-5p, miR-4257, etc.) instead of a single PSA marker. Each miRNA is detected using specific nucleic acid probes, allowing individual marker assessment and combination analysis to improve overall detection accuracy and reduce false positives.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent employs a composite detection strategy by combining multiple miRNA markers in a single detection system. The kit includes nucleic acid probes for detecting combinations of miRNAs, where the combined expression patterns of multiple markers provide more reliable cancer detection than single markers alone, thereby improving sensitivity and reducing false positives.

Inventive Principle:
Principle #40Composite materials

2Reliability

If existing miRNA markers are used for detection, then some detection capability is achieved, but validation insufficiency and low specificity remain

Engineering Contradiction:
Improvedetection reliabilityVSAvoidspecificity
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent performs preliminary validation and selection of miRNA markers before implementing the detection system. The specific miRNAs (miR-4443, miR-1908-5p, miR-4257, etc.) were pre-identified and validated as prostate cancer-specific markers through prior research, ensuring their reliability and specificity before being incorporated into the detection kit.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent changes the detection parameters by focusing on specific miRNA expression patterns and ratios rather than absolute levels. The detection system evaluates combined expression patterns of multiple miRNAs and compares them against established thresholds, improving specificity by considering multiple parameters simultaneously rather than relying on single marker levels.

Inventive Principle:
Principle #35Parameter changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The kit and device significantly enhance the detection of prostate cancer by reducing false positives and improving sensitivity, offering a more accurate diagnostic tool for prostate cancer.

Implementation Method 1

a nucleic acid capable of specifically binding to a particular miRNA

Methodology Applied
Scientific EffectNucleic acid hybridization:

Data Source

PatentUS12480165B2Prostate cancer detection kit or device, and detection method
Publication Date: 2025.11.25 TORAY INDUSTRIES INC
  • US12480165B2 patent drawing
  • US12480165B2 patent drawing
  • US12480165B2 patent drawing

AI summary

An object of the present invention is to provide a kit or a device for the detection of prostate cancer and a method for detecting prostate cancer. The present invention provides a kit or a device for the detection of prostate cancer, comprising a nucleic acid capable of specifically binding to a miRNA in a sample of a subject, and a method for detecting prostate cancer, comprising measuring the miRNA in vitro.