PreCursor-M Gold
The methylation assay pipeline of Self-screen has been extended with the Precursor-M Gold assay, which is currently available for Research Use Only indications.
The concept of the PreCursor-M Gold assay is similar to the PreCursor-M+/ QIAsure Methylation Test, with different target genes.
PreCursor-M Gold Assay (RUO)
PreCursor-M Gold is a multiplex real-time methylation-specific PCR assay for the detection of promoter hyper methylation levels of 2 cervical cancer associated tumor suppressor genes. The assay contains internal sample quality and PCR controls and can be performed on bisulfite-converted DNA prepared from human sample material.
The PreCursor-M Gold is offered as a ready-to-use kit and can be used with standard laboratory equipment, including Rotor-Gene Q 5plex or alternative real time cyclers. A calibrator shipped with each kit, provides state-of-the art experimental reliability.
The concept of the PreCursor-M Gold assay is similar to the QIAsure Methylation Test (https://self-screen.nl/qiasure-methylation-test/), with different target genes.
The PreCursor-M Gold assay has the advantage that it not only demonstrates good (analytical) performance of physician taken cervical scrapes and self-collected cervico-vaginal specimens, but also on urine samples.
Considered applications for the use of PreCursor-M Gold
The RUO version of the PreCursor-M Gold assay can clinically be further developed and validated for applications such as:
- Triage testing of HPV positive and/ or ASCUS/LSIL women
- Treatment guidance and/ or test of cure for women with cervical lesions
- Other clinical indications related to HPV-induced (pre)cancers
PreCursor-M Gold literature and studies
Clinical studies on triage testing by methylation
Verhoef et al. Int J Cancer. 2025 Mar 1;156(5):1065-1073.
About: The clinical performance of host cell DNA methylation and/or HPV genotyping as triage tools for colposcopy referrals and CIN3 detection in HPV-positive women with low-grade cytology from a population-based Dutch primary HPV screening trial.
Methylation testing for the detection of recurrent cervical intraepithelial neoplasia.
Dick et al. Int J Cancer. 2023 Dec 15;153(12):2011-2018.
About: The clinical performance of PreCursor-M Gold for methylation testing in detecting recurrent cervical intraepithelial neoplasia (CIN) using cervical samples.
Vink et al. Clin Infect Dis. 2023 Feb 8;76(3):416-423.
About: The clinical performance of ASCL1 and LHX8 methylation analysis as a primary cervical cancer screening strategy in South African women with HIV.
Verhoef et al. Int J Cancer. 2022 Feb 1;150(3):440-449.
About: The clinical performance of DNA methylation analysis of ASCL1, LHX8, ST6GALNAC5, GHSR, ZIC1, and SST for the triage of HPV-positive women in a Dutch primary HPV-based screening cohort.
Clinical studies on posttreatment monitoring
Vink et al. AIDS. 2022 Jun 1;36(7):953-961.
About: The clinical performance of ASCL1/LHX8 methylation analysis for posttreatment monitoring in women with HIV treated for cervical intraepithelial neoplasia grade 2/3.
Clinical studies on self-sampling and urine sampling
Verhoef et al. Br J Cancer. 2023 Jul;129(1):104-111.
About: The clinical performance of DNA methylation biomarkers ASCL1 and LHX8 on HPV-positive self-collected samples from primary HPV-based screening.
Van den Helder et al. Clin Cancer Res. 2022 May 13;28(10):2061-2068.
About: The clinical performance of HPV and DNA methylation testing in urine for the detection of cervical intraepithelial neoplasia and cervical cancer.
Triage of human papillomavirus infected women by methylation analysis in first-void urine.
Van Keer et al. Sci Rep. 2021 Apr 12;11(1):7862.
About: The clinical performance of methylation analysis in first-void urine for the triage of human papillomavirus-infected women.
Van Keer et al. Eur J Obstet Gynecol Reprod Biol. 2017 Sep;216:1-11.
About: The clinical performance of first-void urine as a potential biomarker source for the triage of high-risk human papillomavirus-infected women.
