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    Home > Medical News > Medicines Company News > Non-invasive liquid biopsy helps cancer diagnosis obtain CE certification

    Non-invasive liquid biopsy helps cancer diagnosis obtain CE certification

    • Last Update: 2021-07-19
    • Source: Internet
    • Author: User
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    Datar Cancer Genetics, a global leader in non-invasive cancer diagnostics, has obtained the European Conformity Certification (CE) mark with its innovative TruBlood solution, a new paradigm for cancer detection, diagnosis and management

    .


    TruBlood is a blood-based non-invasive test method used to diagnose and evaluate suspected cancer cases for which a biopsy is recommended

    .
    The CE mark confirms that TruBlood meets the requirements of the European Medical Device Directive

    .
    Datar Group intends to commercialize this solution in the United Kingdom, the European Union and other regions that recognize the CE mark

    .


    The TruBlood solution evaluates the presence of micro-tumor cell clusters (C-ETACS) circulating in the blood

    .
    These cells are very common in the blood of cancer patients and cannot be detected in individuals without cancer

    .
    This test will be of great help to people who suggest to the doctor that the breast, lung, prostate, colon, and brain may indicate suspicious growth of malignant tumors

    .


    Most suspected cases are usually just benign tumors, so this method can avoid dangerous and often painful and resource-consuming invasive routine biopsies

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    This innovative blood test can also help diagnose cases where invasive biopsy cannot be performed due to various reasons (such as tumor proximity to vital organs or blood vessels), or for diagnosis of patients with comorbidities

    .


    Datar Group intends to use TruBlood as a low-risk, patient-friendly diagnostic evaluation method for clinical medical pathways, allowing patients who have detected C-ETAC to receive biopsy first, while patients with negative C-ETAC test results may consider further evaluation in the future Or accept other methods of diagnosis

    .


    TruBlood marks a major leap in cancer diagnosis technology; Datar Group expects that by combining the latest advances in cancer biology and genomics technology to improve safety and effectiveness, this non-invasive detection method will bring benefits to both medical institutions and patients Benefit

    .
    The main advantages of TruBlood are non-invasive, no hospitalization, and excellent specificity and sensitivity

    .


    Commenting on the announcement, Dr.
    Tim Crook, a physician oncologist at Mid Essex Health Trust, said: “TruBlood is an innovative investigation method that can help diagnose many types of cancer with only a blood sample

    .
    This method uses cutting-edge methods.
    The genome analysis of the company can identify cancer with high accuracy.

    TruBlood is an exciting advancement that will be used for many applications in the field of cancer diagnosis
    .
    "


    Dr.
    Nick Plowman, an oncologist at St.
    Bartholomew’s Hospital in London, said, “Collecting tumor cell clusters from the peripheral blood is like a non-invasive microbiopsy of a tumor

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    It is somewhat surprising that even in the early stages of cancer, this A variety of circulating tumor cell (CTC) clusters will also appear, and the enrichment technology developed by Datar Cancer Genetics improves the detection rate and detection volume

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    The evaluation of these cancer cell clusters can facilitate the diagnosis of cytopathology (tissue origin)

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    This test Not only is it patient-friendly, but it can also track the cancer's genome evolution (and its persistence) during treatment

    .
    "


    In the preliminary data of the TruBlood testing method published in the International Journal of Cancer (2019), more than 16,000 blood samples have been tested, including 5,000 cancer patients and more than 10,000 people without cancer symptoms to prove C- ETAC is a functional feature of solid organ cancers

    .
    A subsequent study published landmark data in the 2020 American Cancer Society Journal Cancer Cytopathology, showing how non-invasive blood testing (liquid biopsy) can accurately distinguish between non-cancerous tumors and cancerous hyperplasias ; The research is based on a multi-agency international cooperation project involving more than 30,000 subjects, including approximately 9,000 known cancer cases

    .
    Overall, the TruBlood technology was developed based on the evaluation of more than 40,000 blood and tumor samples from approximately 22,000 cancer patients

    .

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