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    Home > Biochemistry News > Biotechnology News > FDA's latest recommendation: ctDNA liquid biopsy still needs to be improved in this regard

    FDA's latest recommendation: ctDNA liquid biopsy still needs to be improved in this regard

    • Last Update: 2021-06-04
    • Source: Internet
    • Author: User
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    ctDNA liquid biopsy is currently a hot spot in precision oncology application research.


    Compared with traditional tumor tissue biopsy technology, ctDNA liquid biopsy has more advantages, such as fast sampling speed, low price, minimal invasiveness, and the ability to track a series of tumor development and changes.


    Recently, a joint team led by the US FDA, the research group of the University of Arkansas Medical Sciences, the US National Toxicology Research Center, the SEQC2 Oncopanel Sequencing Working Group and other research groups published a title of Evaluating the analytical validity in the sub-Journal Nature Biotechnology.


    As mentioned in the article, with the rapid development of ctDNA liquid biopsy, this technology is also facing major challenges.


    doi :10.


    The study mentioned that although ctDNA liquid biopsy is rapidly being used in precision oncology, its shortcomings need more attention.


    As a result, the research team used simulation and synthesis control experiments, and added a laboratory capability comparison verification of artificial human ctDNA as a reference substance to measure the impact of each step variable in the ctDNA sequencing workflow.


    In the synthetic control experiment, the researchers used synthetic DNA called "sequins" to evaluate the effectiveness of ctDNA in detecting mutations.


    Next, the research team brought together Roche, Imena, IDT, Burning Rock Medicine, and Thermo Fisher Scientific, five companies with leading technologies in the ctDNA field, to conduct tests and evaluations on their liquid biopsy products.


    Test operation process and partial analysis

    In this assessment, the researchers conducted rigorous analysis and research on multiple indicators such as the coverage depth and heterogeneity, sensitivity, accuracy, repeatability, free DNA input and the impact of blood draw of ctDNA liquid biopsy.


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    In summary, the conclusion of this study is that at present, improving the detection of VAF mutations below 0.


    Reference materials:

    [1]https://

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