Immunocytochemical double-staining for reliable detection of high-grade cervical lesions
Ref-Nr: TA-2017/60
Kurzfassung
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.
Hintergrund
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.
Problemstellung
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.
Lösung
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 (%) | 100 | 84,09 | 93,94 | 77,27 | |
Sensitivity (%) | 94,37 | 100 | 95,52 | 100 | |
PPV (%) | 100 | 88,89 | 96,97 | 84,85 | |
NPV (%) | 89,2 | 100 | 91,18 | 100 |
Vorteile
- overtreatment and complications resulting from unnecessary interventions can be prevented
- applicable and safe way to test for cervical malignancies during pregnancy
Anwendungsbereiche
- 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)
Service
We are looking for partners who are interested in commercialization of the invention. Various licensing models are negotiable.
Publikationen & Verweise
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)
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Universität des Saarlandes Wissens- und Technologietransfer GmbH
Dr. Melanie Hennchen
0681 302-6382
melanie.hennchen@uni-saarland.de
www.wut-uni-saarland.de
Adresse
Universität des Saarlandes Wissens- und Technologietransfer GmbH
Starterzentrum | Gebäude A1 1
66123 Saarbrücken
Entwicklungsstand
Prototyp
Stichworte
CIN, cervical cancer, HPV, immuncytochemistry, EMT-marker, proliferation marker, cervical lesion, diagnosis, pregnancy, cervical, malignancy, oropharyngeal