Today there is a strong agreement in the scientific community regarding the hr-HPV testing superiority in cervical cancer primary screening versus cytology. However, due to the limited specificity of hr-HPV testing, new biomarkers are needed in order to triage the positive cases, avoiding overtreatment and excessive referral to colposcopy. DNA methylation (viral and host) has been proposed as a promising strategy. This work aims to evaluate clinical specificity and sensitivity of a host methylation panel proposed by Hansel et al., in 2014 with some modifications (GynTect®).
A maximum of 100 consecutive PreservCyt® samples diagnosed with LSIL and histology follow-up were selected from the routine diagnostics at LAP Unilabs Porto. In order to access sensitivity some other samples with histologically confirmed CIN3+ lesions were also included. All results were compared with previous cytology, HPV status, CINtec® Plus results and histology data available for that sample. Information regarding the evaluated sample, patient information and data regarding other clinical history related to that patient were taken from the laboratory database to allow the clinical significance of the results to be assessed. All data stored for the evaluation was anonymized. The gold standard is histologically confirmed cervical intraepithelial neoplasia (CIN) grade 3+. Sensitivity and specificity of each of the triage tests was calculated based on disease defined as CIN 3+ (p16 stain confirmed).
All DNA methylation panel testing were performed in the Roche cobas®480z analyzer (component of the cobas®4800 system).
Data is being collected, but the results are not yet fully available.
Preliminary data confirms the capability of the markers to detect high grade disease, with a low false-positive rate.
(Hansel A, Steinbach D, Greinke C, Schmitz M, Eiselt J, Scheungraber C, et al. (2014) A Promising DNA Methylation Signature for the Triage of High-Risk Human Papillomavirus DNA-Positive Women. PLoS ONE 9(3): e91905. https://doi.org/10.1371/journal.pone.0091905)