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Immunocytochemical double-staining for reliable detection of high-grade cervical lesions

Ref-Nr: TA-2017/60


Scientists of the medical school of Saarland University developed a new immunocytochemical double-staining for a reliable detection of high-grade cervical dysplasia to avoid overtreatment and complications resulting thereof.


Cervical cancer is the fourth most common cancer in women with approximately 570.000 new cases in 2018. The most common reason for cervical cancer is a persisting infection with high-risk HP-viruses. Since low grade and moderate cervical intraepithelial neoplasia (CIN), which occur rather frequently, show a high potential for complete healing, only a few women actually develop malignant lesions. As the sensitivity and specificity of cervical cytology varies widely, numerous biomarkers for epithelial lesions have been investigated and established.


It is still challenging to detect and only treat high-grade lesions which lack the potential of self-healing. This in turn leads to a large number of cases of overtreatment. There is a great need for reliable testings concerning CIN classification of a specimen to avoid overtreatment and complications, which can occur thereof.


Scientists of the medical school of Saarland University developed a new immunocytochemical double-staining for Sec62 and Ki67. Sec62 is used as an epithelial-to-mesenchymal transition (EMT) marker, whilst Ki67 is widely used as proliferation marker. This method offers an opportunity for the highly precise detection of high-grade cervical lesions (CIN3+). Sensitivity and specificity of the Sec62/Ki67 double-staining are 100% and 84,09% for CIN3+ lesions. Same samples showed for the double-staining of p16 and Ki67 also a sensitivity of 100% but an obviously lower specificity of 77,27% for CIN3+.


  Sec62/Ki67 dual stain     p16/Ki67 dual stain  
  CIN2+ CIN3+   CIN2+ CIN3+
Specificity (%) 10084,09 93,9477,27
Sensitivity (%) 94,37100 95,52100
PPV (%) 100 88,89   96,97 84,85
NPV (%) 89,2 100   91,18 100


  • overtreatment and complications resulting from unnecessary interventions can be prevented
  • applicable and safe way to test for cervical malignancies during pregnancy


  • cervical cancer screening
  • precise grading of (pre-)malignant cervical lesions
  • the staining is potentially also applicable for the detection of other HPV-induced (pre-)malignant lesions (for example oropharyngeal cancers)


We are looking for partners who are interested in commercialization of the invention. Various licensing models are negotiable.

Universität des Saarlandes Wissens- und Technologietransfer GmbH

Dr. Melanie Hennchen
0681 302-6382
Universität des Saarlandes Wissens- und Technologietransfer GmbH Starterzentrum | Gebäude A1 1
66123 Saarbrücken




CIN, cervical cancer, HPV, immuncytochemistry, EMT-marker, proliferation marker, cervical lesion, diagnosis, pregnancy, cervical, malignancy, oropharyngeal

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