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    TEST:
    Precursor-M+/QIAsure Methylation Test

    Company:
    Self-screen
    Type:
    CE Marked
    Related tests:
    Details
    Evidence

    News

    7ms
    Methylation analysis to detect CIN3+ in hrHPV-positive self-samples from the population-based cervical cancer screening program. (PubMed, Mod Pathol)
    This new panel, consisting of ITGA4, ASCL1, and FAM19A4, has a sensitivity of 84% and a specificity of 70%, similar to our previously identified panel (ANKRD18CP, LHX8, and EPB41L3). Thus, in addition to our previously identified panel, the combination of ITGA4, ASCL1, and FAM19A4 showed good diagnostic performance and potentially can replace cytology, thereby avoiding additional doctor's visits for many women worldwide and reducing the time for decision-making for referral to the gynecologist.
    Journal
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    ITGA4 (Integrin, alpha 4) • ASCL1 (Achaete-Scute Family BHLH Transcription Factor 1) • EPB41L3 (Erythrocyte Membrane Protein Band 4.1 Like 3)
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    GynTect® • Precursor-M+/QIAsure Methylation Test
    11ms
    HIPPOPROJECT: HPV Testing In Polish POpulation-based Cervical Cancer Screening Program. (clinicaltrials.gov)
    P=N/A; Active, not recruiting --> Completed
    Trial completion
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    CINtec® PLUS Cytology • Precursor-M+/QIAsure Methylation Test
    12ms
    HIPPOPROJECT: HPV Testing In Polish POpulation-based Cervical Cancer Screening Program. (clinicaltrials.gov)
    P=N/A; N=33000; Active, not recruiting; Sponsor:Maria Sklodowska-Curie National Research Institute of Oncology
    Trial completion date
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    CINtec® PLUS Cytology • Precursor-M+/QIAsure Methylation Test
    1year
    Comparing the Costs and Diagnostic Outcomes of Replacing Cytology with the QIAsure DNA Methylation Test as a Triage within HPV Primary Cervical Cancer Screening in The Netherlands. (PubMed)
    Irrespective of relative performance, the cost per complete screen was lower and fewer people were lost to follow-up when using DNA methylation testing. The results indicate that, within an HPV primary screening programme that incorporates self-sampling, using the QIAsure Methylation Test for triage reduces the cost per screen compared to LBC.
    Journal • Epigenetic controller • Cytology
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    Precursor-M+/QIAsure Methylation Test
    over1year
    MANAGEMENT AND STRATIFICATION OF PATIENTS WITH AGC-FN PAP SMEAR (ESGO 2023)
    In the HPV negative subgroup we recommend an close examination of the uterine cavity and pelvic organs in addition to colposcopy/biopsy. In our experience, irrespective of HPV status, a positive methylation test predicts precancer or malignancy.
    Clinical
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    Precursor-M+/QIAsure Methylation Test
    2years
    Fujirebio Europe Receives Distribution Rights to Market Self-screen’s PreCursor-M+ Methylation-specific Molecular Assay, a Powerful Solution to Identify Women at High Risk for Cervical Cancer (Self-screen Press Release)
    "Fujirebio Europe and Self-screen B.V. today announce a commercial collaboration around the distribution of the PreCursor-M+ methylation-specific molecular IVD assay from Self-screen B.V. The test is intended for the qualitative detection of elevated methylation levels of cervical cancer biomarkers and may be used as a triage follow-up test of human papillomavirus (HPV) positive women and women with ASCUS/ LSIL cytology results. It complements Fujirebio's HPV-specific molecular test portfolio."
    Licensing / partnership
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    Precursor-M+/QIAsure Methylation Test