Serum Biomarker Panel for Colorectal Cancer Risk Assessment
Solution Overview
Problem
Current screening methods for colorectal cancer are invasive, have low sensitivity, and fail to detect early-stage cancerous lesions effectively, leading to poor compliance and missed opportunities for early treatment.
Innovation Solution
A serum-based multiplex protein assay that detects a combination of markers such as ferritin, keratin 1-10, IL-8, CEA, and L1CAM, along with additional markers like GDF15, in a sample from a subject, using specific reagents and secondary antibodies to assess the presence or risk of colorectal cancer, stratified by stage, through a supervised machine learning algorithm.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If current screening methods (FOBT, FIT, colonoscopy) are used, then cancer detection is performed, but sensitivity for early-stage lesions is low and invasive procedures are required
Solution Approach 1:
The invention segments the detection process by using a two-stage approach: first a non-invasive serum biomarker panel to identify high-risk individuals, then colonoscopy only for those who need it. This segments the population into low-risk (no further testing) and high-risk (colonoscopy recommended) groups, improving early detection while reducing unnecessary invasive procedures.
Solution Approach 2:
The invention introduces serum biomarkers (CEA, CA19-9, sialic acid, and other proteins) as intermediary indicators that can be detected non-invasively from blood samples. These biomarkers serve as mediators between the cancerous lesions and the detection system, allowing indirect detection of early-stage cancer without requiring direct visualization through invasive procedures.
2Ease of operation
If FOBT is used for screening, then detection is non-invasive, but specificity is low resulting in high false positive rate
Solution Approach 1:
The invention merges multiple biomarker detections into a single comprehensive test panel, combining CEA, CA19-9, sialic acid, and additional proteins (GDF15, hepsin, IL-8, keratin 1-10, L1CAM, MCP-1, OPG, YKL-40) into one serum-based assay. This combination approach maintains the non-invasive nature of blood sampling while dramatically improving specificity by requiring a pattern of multiple biomarkers rather than relying on a single marker.
Solution Approach 2:
The invention creates a composite diagnostic signature by combining multiple biomarker measurements into an integrated risk assessment model. Rather than using individual biomarkers separately, the patent synthesizes a composite indicator system that evaluates the collective pattern of biomarker levels, thereby achieving high specificity while maintaining non-invasive sampling.
3Device complexity
If single marker assays are used, then assay simplicity is maintained, but sensitivity for early cancer detection is insufficient
Solution Approach 1:
The invention creates a universal serum biomarker panel that serves multiple functions: it detects early-stage cancer, identifies high-risk adenomatous polyps, and stratifies risk to guide further testing decisions. The same multi-marker assay platform is used across different screening scenarios, providing a versatile solution that improves sensitivity without requiring multiple separate tests.
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
This method provides a non-invasive, highly sensitive approach to detect colorectal cancer at various stages, improving early detection and treatment compliance by accurately identifying adenomatous polyps and cancer stages, enabling targeted treatment regimens.
Implementation Method 1
detecting at least five different polypeptides and/or nucleic acids coding for the polypeptides in the sample by contacting the sample with at least five different reagents, each reagent specifically detecting the presence and/or an amount of one of the at least five different polypeptides
Implementation Method 2
determining whether the combination of the presence and/or detected amounts of each of the at least five different polypeptides and/or nucleic acids coding for the polypeptides along with age and FIT concentration is indicative of the presence of or an increased risk of the presence of colorectal cancer
Data Source
AI summary
This disclosure provides kits and methods for detecting markers in a sample from a subject with unknown status and generating a risk assessment of the presence or absence of cancer, such as colorectal cancer. In embodiments, a kit comprises at least five reagents, each specifically binding to one of at least five polypeptides in a sample from the subject. The polypeptides include at least ferritin, keratin 1-10, IL-8, CEA, and LI CAM. The kit further includes at least one standard comprising a known amount of at least one of the polypeptides. The kit can also include computer readable media comprising instructions to analyze the detected amounts of the at least four polypeptides along with FIT concentration and age using a machine learning algorithm to determine whether a subject has an increased risk of the presence of colorectal cancer.