Trial data

Clinical performance of GynTect®

Current data on the performance of GynTect were presented on international conferences.

  • Data on the prognostic value of GynTect: Eurogin 2015
  • Data on the sensitivity and specificity with >500 samples: Eurogin 2016
  • Data in comparison to CINtec Plus and cobas HPV: Eurogin 2017
  • Data in comparison to QIAsure: Eurogin 2018
  • Data on the sensitivity and specificity with >300 samples, GynTect performed on a cobas Z480 analyzer: Eurogin 2018

In the triage of women tested HPV-positive, GynTect® has a very good sensitivity and specificity.

You’ll find current publications regarding sensitivity and specificity of GynTect here:

The graph shown in here showes the performance in a blinded observational trial, where data were obtained for the GynTect® markers compared to histopathology findings. In this trial all cancer cases were detected by the markers. Furthermore, in patients aged 30 years and older, 90% CIN3 were detected by the GynTect® markers. This demonstrates that GynTect® has a very good sensitivity for CIN3 and cancer cases.

Cervical cancer develops very slowly from dysplastic changes. In ongoing studies we want to demonstrate if GynTect® detects exactly those dysplastic lesions that have the potential to progress to carcinomas.

These data and data on tissue samples are published here: Hansel et al, PLoS one (2014)

CIN = Cervical Intraepithelial Neoplasia. CIN 1 and CIN 2: mild to moderate dysplasia; CIN 3: severe dysplasia