PreCursor-M+

Qualitative detection of promotor hypermethylation of 2 cervical cancer associated genes (FAM19A4 and hsa-miR124-2).

Identify HPV positive women with high short-term progression to (pre)cancer.

Special Features:

  • Sample types:
    • Bisulfite-converted DNA isolated from physician collected cervical specimens or self-collected vaginal specimens
  • Clinical performance - Long-term data:   
    • Most evaluated and validated methylation assay to identify HPV positive women with progressing cervical disease in direct need for colposcopy or other follow-up procedures1,2
    • Demonstrating very high sensitivity for cervical cancer detection (95.0-100%) in HPV-positive cervical specimens2,3,4
    • Longitudinal data: The long-term risk for cancer with a negative PreCursor-M+ is lower than with a negative cytology result; for CIN3 the long-term risk is similar as cytology5,6 
  • Flexible:
    • Suitable for various sample types, including self-samples and common Liquid Based Cytology media types
    • Compatible with standard DNA extraction methods
  • Reliable:     
    • Build-in check for sample quality ensuring reliable results 

Precursor-M+ is a registered trademark of the legal manufacturer, Self-screen B.V., the Netherlands, and is distributed by Fujirebio Europe.

CE marked
PreCursor-M+

Product number 81352

72 Tests
Please contact your local Fujirebio representative for the availability of this product in your country.

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  • Details

    Technical Specifications:

    • Method:
      • Multiplex real-time methylation-specific PCR assay
    • Target:
      • Promotor hypermethylation of 2 cervical cancer associated genes (FAM19A4 and hsa-miR124-2)
    • Sample types:
      • Cervical specimens stored in PreservCyt Solution or HC2 DNA Collection device
      • Self-collected vaginal brush/broom samples
    • Sample volume:
      • Input in the PreCursor-M+ reaction is 2.5 μL of bisulfite-converted DNA
    • Reaction time:
      • Total time to result: 4 - 24hrs. (incl. DNA extraction and bisulfite conversion; semi-automated or manual workflow)
        PreCursor-M+ assay:
      • Run time in real-time PCR cycler: within 90 minutes
      • Hands-on time: 20 minutes
    • Equipment:​​​​​​
      • Mic qPCR cycler (Bio Molecular Systems)
      • QPCR software (Bio Molecular Systems)
      • PreCursor-M+ v.1.0.mic template

     

    References:

    1. Kremer WW, Steenbergen RDM, Heideman DAM, Kenter GG, Meijer CJLM. The use of host cell DNA methylation analysis in the detection and management of women with advanced cervical intraepithelial neoplasia: a review. BJOG 2021;128:504-514
    2. Bonde J. et al. Int. J. Cancer. 2021;148:396-405. Methylation markers FAM19A4 and miR124-2 as triage strategy for primary human papillomavirus screen positive women: A large European multicenter study.
    3. Vink F.J. et al. Int J Cancer. 2020;147:1215-1221

    4. Hampl M. et al. Int J Cancer. 2022 ;1-8

    5. De Strooper et al. Cervical cancer risk in HPV-positive women after a negative FAM19A4/mir124-2 methylation test: A post hoc analysis in the POBASCAM trial with 14-year follow-up. Int. J. Cancer 2018;143(6):1541-1548 

    6. Dick et al. Long-term CIN3+ risk of HPV positive women after triage with FAM19A4/miR124-2 methylation analysis. Gynecol Oncol. 2019;154(2):368-373
  • Conditions of sale

    To read the end user conditions of sale for this product please visit our Resource center.

  • Citations

    The BIOZ badges associated with Fujirebio products include peer-reviewed citations derived from scientific studies using Fujirebio products. Please note that the peer-reviewed citations do not reflect the regulatory status of Fujirebio products. Users should refer to the specific product documentation and any (clinical) claims made therein in order to ensure compliant use. For each country or geographic region, users must verify the related regulatory status of the Fujirebio product.

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