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New immunocytochemical double-staining for the diagnosis of cervical premalignant and malignant lesions

Dr Zoltan Takacs, Saarland University Medical Center; Dr Maximilian Linxweiler, Saarland University Medical Center; Barbara Linxweiler, Saarland University Medical Center

Universit├Ąt des Saarlandes Wissens-und Technologietranfer GmbH


Cervical cancer is the fourth most common cancer in women with approximately 570.000 new cases in 2018. The most frequently 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. Since the sensitivity and specificity of cervical cytology varies widely, numerous biomarkers for epithelial lesions have been investigated and established. However, 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+. Therefore overtreatment and complications resulting from unnecessary interventions can be better prevented by using this new immunocytochemical double-staining.

Commercial Opportunity

  • Immunocytochemical detection kit for high-grade cervical lesions
  • high sensitivity (100%) and specificity (84,09%) for the detection of CIN3+ lesions
  • prevention of overtreatment and complications resulting from unnecessary interventions
  • potentially also applicable for the detection of other HPV induced (pre-)malignant lesions (for example oropharyngeal cancers)

Development Status


Patent Situation

Priority patent application in June 2018.

Further Reading

Takacs, F.Z., Radosa, J.C., Bohle, R.M. et al. "Sec62/Ki67 dual staining in cervical cytology specimens: a new marker for high-grade dysplasia"; Arch Gynecol Obstet (2018).


New immunocytochemical double-staining for the diagnosis of cervical premalignant and malignant lesions