Colorectal Screening with Bacterial Markers to Reduce FOBT False Positives
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Solution Overview
Problem
Current fecal occult blood tests for colorectal cancer screening have low sensitivity and high false-positive rates, necessitating invasive follow-up procedures like colonoscopy, and there is a need for non-invasive, cost-effective methods with high sensitivity and specificity for early detection of advanced neoplasia.
Innovation Solution
A non-invasive method using bacterial markers Gemella morbillorum, Peptostreptococcus stomatis, and Bacteroides fragilis to complement fecal occult blood tests, reducing false positives and increasing specificity and positive predictive value.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If fecal occult blood test is used for colorectal cancer screening, then non-invasive detection is achieved, but false positive rate increases and sensitivity decreases
Solution Approach 1:
The patent combines fecal occult blood test with bacterial marker detection (Gemella morbillorum, Peptostreptococcus stomatis, and Bacteroides fragilis) into a composite screening system. This merging allows the non-invasive nature of FOBT to be preserved while adding bacterial markers that specifically indicate colorectal neoplasia, thereby reducing false positives and improving diagnostic accuracy without requiring invasive procedures.
2Ease of operation
If fecal occult blood test is used for colorectal cancer screening, then non-invasive detection is achieved, but sensitivity decreases
Solution Approach 1:
The patent merges FOBT with detection of specific bacterial markers (Gemella morbillorum, Peptostreptococcus stomatis, and Bacteroides fragilis) to create a composite test. This combination maintains the non-invasive advantage of FOBT while significantly improving sensitivity, as the bacterial markers are specifically associated with colorectal neoplasia and can detect cases that FOBT alone might miss.
3Measurement precision
If invasive procedures like colonoscopy are used for follow-up, then accurate diagnosis is achieved, but procedure complexity and cost increase
Solution Approach 1:
The patent introduces bacterial marker detection as an intermediary test between the initial non-invasive FOBT and the invasive colonoscopy. This intermediary step filters patients more accurately, reducing the number of false positives who would otherwise undergo unnecessary invasive procedures. The bacterial markers serve as a mediator that maintains diagnostic accuracy while reducing the complexity and cost burden of the overall screening pathway.
Data Source
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AI summary
The present invention relates to an improved method for the screening, diagnosis and/or monitoring of colorectal advanced neoplasia (AN), advanced adenoma (AA) and/or colorectal cancer (CRC), wherein AN encompasses CRC and AA. In particular, said method provides an increase of specificity due to a reduction of false positive results in the fecal occult blood test (FOBT) using a signature based on bacterial markers. It further relates to the use of said method in the selection of subjects for conducting an exploratory test (e.g., a colonoscopy) or for the treatment with an anti-cancer therapy.