Nucleic Acid Analysis for Surgical Margin Detection
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Solution Overview
Problem
Current methods for detecting positive surgical margins in solid tumors are inefficient, with a sensitivity of only 50.9% and high rates of inaccurate analysis, leading to potential recurrence of disease and increased healthcare costs.
Innovation Solution
A system and method for analyzing nucleic acids from surgical specimens using kits that include sample acquisition devices, reagents, and platforms for detecting biomarkers associated with cancer, allowing for intraoperative and postoperative evaluation of surgical margin status.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional microscopy methods are used to detect positive surgical margins, then the analysis can be performed with existing equipment, but the sensitivity is only 50.9% and accuracy is insufficient
Solution Approach 1:
The patent replaces conventional microscopy (mechanical/optical system) with molecular biology-based detection methods including PCR amplification and nucleic acid signature analysis. This substitution enables detection of rare malignant cells at the surgical margin by amplifying and analyzing specific nucleic acid sequences, achieving significantly higher sensitivity (detecting rare cells among millions of benign cells) and accuracy compared to microscopy alone.
Solution Approach 2:
The patent changes the detection parameter from morphological features visible under microscopy to molecular-level nucleic acid sequences. By analyzing specific gene expressions and mutations present in malignant cells but absent in benign tissue, the method achieves superior detection sensitivity and accuracy for positive surgical margins.
2Measurement precision
If conventional microscopy is used for margin analysis, then the process is simple and quick, but it fails to detect rare malignant cells on the surface of surgical specimens
Solution Approach 1:
The patent applies preliminary action by performing nucleic acid extraction and PCR amplification on surgical margin specimens before final analysis. The amplification step pre-concentrates the target malignant cell DNA/RNA signals, making rare malignant cells detectable even when present in very low quantities among abundant benign cells. This preliminary processing enables the subsequent detection system to achieve high sensitivity without requiring equally complex detection hardware.
Solution Approach 2:
The patent introduces nucleic acid molecules as intermediaries between the surgical specimen and the detection system. By converting cellular information into molecular signatures that can be amplified and detected, the method bridges the gap between rare malignant cells and the detection apparatus, achieving high sensitivity without direct observation of individual rare cells.
3Reliability
If inaccurate margin analysis is performed, then additional medical treatments may be required, but this increases healthcare costs and places patients at high health risk
Solution Approach 1:
The patent implements feedback by providing rapid, accurate molecular analysis results during or immediately after surgery. This real-time feedback enables surgeons to make informed decisions about whether additional resection is needed to achieve clear margins, or whether the current resection is sufficient. By accurately identifying positive margins, the system prevents both unnecessary additional surgeries and inadequate resections, optimizing surgical efficiency and patient outcomes.
Data Source
AI summary
Provided herein are kits, devices and methods for rapid analysis of biological samples. In particular, kits, devices and methods described herein can be applied to rapid nucleic acid analysis of solid tissue samples.