Stool Bacterial Biomarker Panels for Early Colorectal Cancer Detection
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Solution Overview
Problem
Current colorectal cancer (CRC) detection methods, such as fecal occult blood tests, are not specific enough for early-stage detection, often leading to late-stage diagnoses and reduced survival rates, necessitating more specific and non-invasive biomarkers.
Innovation Solution
Utilizing a combination of bacterial biomarkers, including Fusobacterium, Parvimonas, Bacteroides, and Faecalibacterium, in intestinal or stool samples, analyzed through amplification reactions and machine learning models, to identify changes in bacterial concentrations indicative of CRC risk or presence.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If fecal occult blood tests (FOBT) are used for CRC screening, then the screening coverage is high and the method is simple, but the specificity is low leading to many false positives and unnecessary colonoscopies
Solution Approach 1:
The invention segments the diagnostic process by introducing a two-stage screening system: first using FOBT for broad coverage, then applying a bacterial biomarker panel test to specifically identify high-risk individuals who need colonoscopy. This segmentation resolves the contradiction by maintaining the simplicity of FOBT while adding a specific molecular filtering layer to reduce false positives.
Solution Approach 2:
The bacterial biomarker panel acts as an intermediary between the simple FOBT test and the invasive colonoscopy procedure. By measuring bacterial concentrations (Fusobacterium, Parvimonas, Bacteroides, Faecalibacterium) as intermediate indicators, the system maintains FOBT's simplicity while achieving higher specificity before committing to colonoscopy.
2Reliability
If colonoscopy is recommended for all FOBT positive cases, then no early-stage CRC is missed, but the workload in hospitals increases significantly due to unnecessary procedures
Solution Approach 1:
The bacterial biomarker panel test is performed as a preliminary action before colonoscopy. By pre-screening FOBT-positive individuals with the bacterial panel, the system identifies which patients truly need colonoscopy, thereby maintaining detection completeness while reducing unnecessary procedures and hospital workload.
Solution Approach 2:
Instead of applying the invasive and resource-intensive colonoscopy to all FOBT-positive cases (excessive action), the invention applies it only to the subset of patients who test positive on both FOBT and the bacterial biomarker panel (partial action). This partial application maintains reliability for high-risk cases while dramatically reducing hospital workload.
3Ease of operation
If FOBT is used for early detection, then the test is non-invasive and inexpensive, but it primarily detects advanced CRC phases (stages III-IV) and misses early-stage cancers
Solution Approach 1:
The invention merges the accessibility of FOBT with the early-stage detection capability of molecular biomarkers. By combining FOBT (which detects advanced stages) with the bacterial panel test (which detects early-stage changes in microbiome composition), the system maintains non-invasiveness and low cost while significantly improving early-stage detection accuracy.
Solution Approach 2:
The invention changes the detection parameter from blood chemistry (FOBT) to bacterial concentration profiles (microbiome composition). By measuring parameters such as Fusobacterium, Parvimonas, Bacteroides, and Faecalibacterium concentrations, the system detects early-stage CRC through microbiome alterations that occur before significant bleeding or mass effect, thereby improving early detection while maintaining test accessibility.
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
Enhances the early detection of colorectal cancer by improving diagnostic performance from modest to high (AUC 0.8), identifying CRC even at early stages missed by colonoscopy, and providing a non-invasive means to assess treatment response.
Implementation Method 1
determining the levels or the concentration of bacteria belonging to the genus Fusobacterium, Parvimonas, Bacteroides and/or Faecalibacterium by performing an amplification reaction from a nucleic acid preparation derived from said sample using at least one pair of primers capable of amplifying at least one representative region of said genus
Data Source
Figure 1
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AI summary
The present invention relates to a bacterial biomarker or to a combination of bacterial biomarkers in intestinal or stool samples which on one hand help in the diagnosis of colorectal cancer, and on the other hand predict the progression of colorectal cancer, as well as the response to treatment of a subject suffering from this disease.