ctDNA Liquid Biopsy is a molecular diagnostic technique that involves the detection and analysis of circulating tumor DNA (ctDNA) present in a patient's blood plasma. This method allows for non-invasive monitoring of cancer by identifying fragments of DNA released from tumor cells into the bloodstream.
It addresses the need for non-invasive methods to monitor cancer progression, treatment response, and early detection of relapse or recurrence without the need for invasive biopsies. This technique also provides a way to track minimal residual disease (MRD) in patients undergoing cancer therapy.
High-depth Next-Generation Sequencing (NGS) is used to sequence the ctDNA, enabling the identification of somatic mutations that are characteristic of the tumor. By comparing the sequence data with a reference genome, researchers can detect and quantify these mutations, which provide valuable information about the presence and characteristics of the cancer.
The manufacturing process involves sample collection from blood plasma, followed by extraction and purification of ctDNA. The purified DNA is then subjected to high-depth NGS sequencing using specialized equipment and bioinformatics tools for data analysis.
The build process includes the development of efficient protocols for ctDNA extraction and purification, as well as the optimization of NGS workflows to ensure accurate and reproducible results. Validation studies are conducted to establish the sensitivity and specificity of the method.
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