UroVysion FISH Panel for Bladder Cancer Detection
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Solution Overview
Problem
Current non-invasive bladder cancer detection methods, such as urine-based tests and cytology, are inadequate for early detection and surveillance, particularly for low-grade lesions, and there is a need for improved diagnostic tools to monitor bladder cancer patients effectively.
Innovation Solution
A method using in situ hybridization with labeled nucleic acid probes specific to chromosomal abnormalities associated with bladder cancer, including centromeric and locus-specific probes for chromosomes 3, 7, 10, and 5p15, to detect bladder cancer or precursor cells in biological samples like urine, enabling selective identification through hybridization patterns.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If current non-invasive urine-based tests and cytology are used for bladder cancer detection, then patient convenience is improved and invasive procedures are reduced, but detection sensitivity and specificity for early-stage and low-grade lesions deteriorate
Solution Approach 1:
The invention segments the detection approach by combining multiple independent molecular markers (NMP22, BTA, UroVysion FISH) into a panel system. Each marker detects different aspects of bladder cancer pathology, and their combined use provides complementary information that overcomes the limitations of individual markers, thereby improving overall detection sensitivity while maintaining non-invasive patient convenience
Solution Approach 2:
The invention creates a composite diagnostic approach by integrating results from multiple molecular marker tests. The panel combines proteins, mRNA, and chromosomal abnormality detections into a unified diagnostic system that leverages the strengths of each component while compensating for individual weaknesses, achieving superior detection performance compared to single-marker approaches
2Measurement precision
If molecular urinary markers are added to improve detection accuracy, then detection sensitivity is improved, but test complexity and cost increase
Solution Approach 1:
The invention merges multiple molecular marker assays into a single integrated panel that can be processed together. By combining NMP22, BTA, and UroVysion FISH tests into one comprehensive evaluation, the system achieves improved detection sensitivity while reducing the overall complexity compared to performing separate independent tests, as the markers are evaluated in a coordinated manner within a unified diagnostic framework
3Reliability
If lifelong surveillance with regular urethro-cystoscopy is performed, then detection reliability is improved, but patient burden and healthcare costs increase
Solution Approach 1:
The invention introduces molecular marker panels as intermediary screening tools between routine physical exams and invasive urethro-cystoscopy procedures. These non-invasive urinary tests serve as mediators that can detect bladder cancer markers in urine, allowing clinicians to identify at-risk patients who truly need cystoscopy while sparing low-risk patients from unnecessary invasive procedures, thereby reducing patient burden while maintaining detection reliability
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 approach provides high sensitivity and specificity for detecting bladder cancer, potentially reducing the need for invasive procedures like cystoscopy and improving monitoring of cancer recurrence, allowing for more effective patient management and early detection of aggressive tumors.
Implementation Method 1
a set of labeled nucleic acid probes are hybridized to cells in a biological sample, preferably a urine sample or biopsy, to selectively detect a bladder cancer or precursor cells thereto in the sample
Data Source
AI summary
Methods and kits are provided for screening a patient for bladder cancer. Embodiments include those involving centromeric probes to chromosomes 3, 7, and 10 and a locus-specific probe to 5p15.