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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:
- Trial using GynTect in comparison to CINtec Plus and cobas HPV: Schmitz et al, BMC Cancer 2018
- GynTect Performance on STM samples: Schmitz et al, Clin Epigenetics (2017)
- GynTect performance on 100 samples at our partnerlab from Medirex: Eichelkraut et al, Newslab (2017)
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