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    Home > Active Ingredient News > Study of Nervous System > Courier blood test to diagnose Alzheimer's disease, innovative test was recognized by FDA as a breakthrough medical device

    Courier blood test to diagnose Alzheimer's disease, innovative test was recognized by FDA as a breakthrough medical device

    • Last Update: 2021-10-21
    • Source: Internet
    • Author: User
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    ▎Editor of WuXi AppTec's content team On October 12, 2021, Quanterix announced that its blood test Simoa phospho-Tau 181 (pTau-181) has been granted a breakthrough medical device designation by the US FDA to assist in the diagnosis of Alzheimer's Disease (AD)
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    Simoa pTau-181 is a semi-quantitative immunoassay method that measures the concentration of pTau-181 in the serum and plasma of patients
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    Threonine 181 is one of the phosphorylation sites of tau protein
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    Tau is a microtubule stabilizing protein, mainly located in central nervous system (CNS) neurons, but it is also expressed at low levels in astrocytes and oligodendrocytes
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    According to 6 different subtypes of Tau, the molecular weight ranges from 48,000 to 67,000 Daltons
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    The Simoa pTau-181 detection kit targets the proline-rich region of Tau protein, which is highly conserved among these subtypes
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    Abnormal deposition of Tau protein is one of the hallmark pathological features of Alzheimer's disease
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    Elevated Tau can often be observed in the cerebrospinal fluid (CSF) of patients with neurodegenerative diseases and severe head injuries, indicating that it is released outside the cell during neuronal injury
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    In Alzheimer's disease and related neurodegenerative diseases, including chronic traumatic encephalopathy, Tau protein is abnormally phosphorylated and aggregates into bundles of filaments
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    Previous studies have found that pTau 181 has a stronger correlation with Alzheimer's disease markers than overall Tau protein
    .

    ▲Quanterix's technology platform can detect low-abundance/concentration biomarkers in blood (picture source: Quanterix's official website) "Quanterix's technology has the unique ability to detect low-abundance markers in blood samples, which may be earlier , Easier and non-invasive diagnosis of a variety of diseases including Alzheimer’s disease
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    " said Mr.
    Kevin Hrusovsky, Chairman and CEO of Quanterix, "We will continue to work on using our innovative platform to support neurodegeneration.
    Research progress and the transformation of breakthrough scientific discoveries into the clinic
    .

    "Reference: [1] Quanterix Granted Breakthrough Device Designation from US FDA for Blood-Based pTau-181 Assay for Alzheimer's Disease.
    Retrieved October 12, 2021, from https:/ / WuXi AppTec's content team focuses on introducing global biomedical health research progress
    .

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    The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
    .

    This article is not a treatment recommendation either
    .

    If you need guidance on the treatment plan, please go to a regular hospital for treatment
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