Fecal 16S rDNA Quantification for Non-Invasive Colorectal Cancer Screening

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Solution Overview

Problem

Current methods for detecting colorectal cancer (CRC) and adenomatous polyps are inadequate due to low sensitivity, high invasiveness, and high costs, with existing fecal tests producing false positives and negatives, and colonoscopy being costly and risky, necessitating a more effective non-invasive screening tool.

Innovation Solution

Quantification of specific 16S rDNA bacterial sequences (B3, B10, B46, B48) in feces samples using nucleic acid probes and primers to diagnose, detect, and monitor CRC and adenomatous polyps, determining the risk of development and guiding therapy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If fecal blood tests (FOBT/FIT) are used for CRC screening, then the test is non-invasive and easy to perform, but the sensitivity is low and false positives/negatives occur

Engineering Contradiction:

Improvenon-invasive screeningVSAvoiddetection accuracy

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The patent uses bacterial 16S rDNA sequences as intermediary biomarkers that indirectly indicate the presence of CRC. Instead of directly detecting human blood or DNA in feces, the method detects changes in bacterial community composition caused by the disease, thereby improving detection accuracy while maintaining non-invasiveness

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent replaces traditional mechanical/chemical detection methods (blood detection in FOBT/FIT) with molecular biological methods (qPCR detection of bacterial DNA sequences). This substitution enables more specific and sensitive detection of CRC-related bacterial changes without requiring invasive procedures

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Measurement precision

If colonoscopy is performed for CRC detection, then the detection sensitivity and accuracy are high, but the procedure is invasive, costly, and carries risks

Engineering Contradiction:

Improvedetection accuracyVSAvoidinvasiveness and risk

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The patent employs bacterial 16S rDNA sequences as intermediary markers that reflect the underlying pathological changes in CRC. By detecting these bacterial biomarkers in non-invasive fecal samples, the method achieves high detection accuracy comparable to colonoscopy without the associated risks and costs

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent creates a molecular copy or proxy of the diagnostic information obtained from colonoscopy by detecting bacterial DNA sequences in feces that mirror the bacterial changes occurring in the colon tissue. This copying approach provides equivalent diagnostic value through a non-invasive sample

Inventive Principle:

Principle #26Copying

3Ease of manufacture

If conventional fecal tests are used for CRC screening, then the cost is low and accessibility is high, but false positives lead to unnecessary colonoscopies

Engineering Contradiction:

Improvecost-effectivenessVSAvoidtest specificity

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The patent segments the bacterial community analysis into specific targeted detection of individual 16S rDNA sequences associated with CRC, rather than attempting to analyze the entire complex bacterial community. This segmentation enables more specific and reliable detection at lower cost by focusing on disease-relevant bacterial markers

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent changes the detection parameter from general blood presence (FOBT/FIT) or structural visualization (colonoscopy) to specific molecular identification of CRC-associated bacterial DNA sequences. This parameter change enhances test specificity while maintaining cost-effectiveness through qPCR technology

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 method provides a sensitive and specific tool for early detection and monitoring of CRC and adenomatous polyps, reducing unnecessary colonoscopies and improving patient outcomes by using fecal samples to quantify bacterial sequences associated with CRC, offering a non-invasive and cost-effective screening solution.

Implementation Method 1

quantification of one or more 16S rDNA bacterial sequences... using nucleic acid probes and primers to diagnose, detect, and monitor CRC

Methodology Applied

Scientific EffectPCR amplification:

Implementation Method 2

nucleic acid probes and primers for the quantification of said 16S rDNA bacterial sequences

Methodology Applied

Scientific EffectNucleic acid hybridization:

Data Source

PatentUS10927416B2Method for diagnosing colorectal cancer from a human feces sample by quantitative PCR, primers and kit

Publication Date: 2021.02.23 UNIV DE GIRONA

AI summary

The present invention relates to the field of detection of colorectal cancer (CRC). Specifically it relates to methods for the early detection, risk screening and monitoring of CRC and/or adenomatous polyps in a human subject based on the quantification of one or more 16S rDNA bacterial sequences in feces. It further relates to the use of said bacterial sequences as biomarkers of colorectal cancer and/or adenomatous polyps; to a kit comprising a reagent and instructions for the quantification of said bacterial sequences; and to nucleic acids for the quantification of said 16S rDNA bacterial sequences.