Exosomal miRNA Reagent Kit for Early Renal Cancer Detection

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Solution Overview

Problem

Current clinical detection methods for renal cell carcinoma (RCC) are limited by low sensitivity and specificity, high cost, and difficulty in early detection, with surgical resection being the only effective treatment but having high recurrence rates, and lacking reliable tumor markers for early diagnosis.

Innovation Solution

A reagent kit and method using a set of primer-probe mixes for detecting specific miRNAs (miR-23b-5p, miR-34c-5p, miR-210-3p, and miR-508-3p) in exosomes through multiplex qRT-PCR, combined with a Mi-Score calculation for renal cancer risk assessment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If urine occult blood test is used for RCC detection, then the detection method is simple, but the sensitivity is low because hematuria only appears when the tumor reaches a considerable extent

Engineering Contradiction:
Improvedetection simplicityVSAvoiddetection sensitivity
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

The invention extracts and detects specific miRNA molecules (miR-23b-5p, miR-34c-5p, miR-210-3p, miR-508-3p) from exosomes in urine samples, rather than detecting general hematuria. This extraction of specific molecular markers enables early detection before tumors reach a considerable extent, resolving the sensitivity limitation of traditional occult blood tests while maintaining operational simplicity through standardized qRT-PCR protocols

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention replaces the mechanical/chemical detection of blood cells (occult blood test) with molecular biology-based detection of specific miRNA sequences using qRT-PCR. This substitution enables detection at the molecular level, allowing identification of renal cancer at very early stages when tumor burden is minimal, thereby dramatically improving sensitivity while maintaining ease of operation through automated PCR systems

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

2Adaptability or versatility

If biochemical examination is used for renal cancer detection, then the examination reflects general body situation, but it lacks specificity and is difficult to clearly identify renal cancer

Engineering Contradiction:
Improvegeneral body assessmentVSAvoiddetection specificity
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The invention shifts from general biochemical examination to detection of specific miRNA markers (miR-23b-5p, miR-34c-5p, miR-210-3p, miR-508-3p) that are locally enriched in renal cancer exosomes. This local quality approach detects tumor-specific molecular signatures rather than general metabolic changes, achieving high specificity for renal cancer identification while maintaining the ability to assess overall patient status through comprehensive marker evaluation

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The invention segments the general biochemical examination into specific miRNA marker detection. Instead of measuring broad metabolic parameters, the method divides the detection into targeted analysis of four specific miRNA molecules, each with distinct expression patterns in renal cancer. This segmentation enables clear identification of renal cancer while preserving information about general body situation through the collective interpretation of multiple markers

Inventive Principle:
Principle #1Segmentation

3Measurement precision

If imaging examination (MRI and CT scans) is used for renal cancer detection, then the examination has relatively high price and requires large instruments with cumbersome operations, but it may be difficult to detect early renal cancer tumors

Engineering Contradiction:
Improveearly tumor detection capabilityVSAvoidinstrument size and operational complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The invention extracts specific miRNA molecular markers from urine exosomes, eliminating the need for large imaging instruments. By taking out the detection to the molecular level, the method achieves early tumor detection capability comparable to or exceeding imaging methods, while using standard laboratory equipment (qRT-PCR machines) that are much smaller and easier to operate than MRI or CT scanners

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention creates a molecular copy of tumor information through detection of miRNA sequences in exosomes. Instead of imaging the physical tumor mass, the method detects genetic information copies (miRNA molecules) that are shed by tumor cells into urine. This copying approach enables early detection with simple, accessible equipment rather than complex imaging systems

Inventive Principle:
Principle #26Copying

4Reliability

If surgical resection is used for renal cancer treatment, then it is the only effective treatment manner, but 20% to 40% of patients experience recurrence after surgery with mortality rate higher than 40%

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidearly diagnosis capability
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The invention performs preliminary detection of renal cancer through miRNA marker analysis in urine exosomes, enabling diagnosis at very early stages before tumors become surgically significant. By detecting cancer presence through specific miRNA signatures (miR-23b-5p, miR-34c-5p, miR-210-3p, miR-508-3p) before clinical symptoms or large tumor masses develop, the method provides preliminary warning that allows for early intervention and monitoring, potentially preventing the need for aggressive surgery and reducing recurrence risk

Inventive Principle:
Principle #10Preliminary action

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 provides accurate, fast, and cost-effective early detection of RCC with high sensitivity and specificity, improving diagnostic performance compared to existing methods.

Implementation Method 1

a reverse transcription primer R-23b for a specific reverse transcription miR-23b-5p target

Methodology Applied
Scientific EffectReverse transcription:

Implementation Method 2

a universal forward primer Ge—F for fluorescent PCR (polymerase chain reaction) detection

Methodology Applied
Scientific EffectFluorescent PCR:

Implementation Method 3

miRNAs may bind to their target mRNAs through complementary base pairing in the 3′-terminal non-coding regions (3′UTR) of their target mRNAs

Methodology Applied
Scientific EffectComplementary base pairing:

Data Source

PatentUS12391994B2Reagent kit and markers for detecting renal cell carcinoma and method thereof
Publication Date: 2025.08.19 HANGZHOU YORK BIOTECH CO LTD
  • US12391994B2 patent drawing
  • US12391994B2 patent drawing
  • US12391994B2 patent drawing

AI summary

Embodiments of the present disclosure provide a reagent kit and a method for detecting renal cell carcinoma. The reagent kit includes a set of primer-probe mixes for detecting miRNAs in exosomes. The set of primer-probe mixes includes a reverse transcription primer R-23b for a specific reverse transcription miR-23b-5p target, a universal forward primer Ge—F, a specific reverse primer 23b-R, and a specific probe 23b-P; a reverse transcription primer R-34c for a specific reverse transcription miR-34c-5p target, a universal forward primer Ge—F, a specific reverse primer 34c-R, and a specific probe 34c-P; a reverse transcription primer R-210 for a specific reverse transcription miR-210-3p target, a universal forward primers Ge—F f, a specific reverse primer 210-R, and a specific probe 210-P; and a reverse transcription primer R-508 for a specific reverse transcription miR-508-3p target, a universal forward primer Ge—F, a specific reverse primer 508-R, and a specific probe 508-P.