ctDNA Mutation Tracking for Early Therapy Response Prediction
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Solution Overview
Problem
Current prognostic methods for cancer treatment response, such as CT scans, are inadequate for timely detection of disease progression and do not provide real-time quantitative assessment of disease burden, leading to potential delays in alternate therapies.
Innovation Solution
A method involving the measurement of mutant molecules per milliliter of plasma (MMPM) in circulating tumor DNA (ctDNA) to assess treatment response, using a targeted sequencing panel to monitor changes in tumor mutations non-invasively and guide therapy adjustments.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If CT scans are used for disease monitoring, then structural information can be obtained, but the timing is too late to detect disease progression and the resolution is insufficient for smaller tumors
Solution Approach 1:
The patent replaces the mechanical imaging system (CT scan) with a molecular detection system that analyzes circulating tumor DNA. This substitution enables earlier detection of disease progression at the molecular level before structural changes are visible on CT scans, resolving the time delay issue while maintaining precision through quantitative molecular measurement.
Solution Approach 2:
The patent changes the measurement parameter from structural imaging (CT scan) to molecular concentration (ctDNA quantity). By measuring the concentration of circulating tumor DNA molecules, the system achieves both earlier detection timing and sufficient precision for small tumors, as molecular changes occur before structural changes.
2Area of stationary object
If CT scans are used for disease monitoring, then overall imaging coverage is provided, but the resolution is insufficient to accurately assess disease burden in patients with smaller tumors
Solution Approach 1:
The patent substitutes the mechanical CT imaging system with a molecular assay system that quantifies circulating tumor DNA. This replacement provides precise measurement of disease burden through molecular concentration measurement, overcoming the resolution limitations of CT scans for smaller tumors while maintaining comprehensive monitoring capability.
3Ease of operation
If qualitative assessment methods are used for ctDNA, then the approach is simpler, but transition to quantitative measurement is needed to guide patient care in real time
Solution Approach 1:
The patent changes the assessment parameter from qualitative presence/absence to quantitative concentration measurement (mutations per milliliter of plasma). This parameter change enables real-time guidance of patient care by providing numerical data that can be dynamically interpreted during treatment, while the methodology remains operationally straightforward through standardized molecular assays.
Data Source
AI summary
The invention is a method of predicting response to therapy in a cancer patient by serial sampling the patient's cell-free tumor nucleic acids to determine a change in the number of mutations per amount of plasma.