Novel epigenetic biomarkers
CC Diagnostics collaborates with the DNA methylation ResearchGroup at the UMCG (headed by Dr G. Bea A. Wisman, molecular biologist and external scientific advisor for CC Diagnostics, and by Prof Dr. Ed Schuuring, clinical scientist in molecular pathology). During their fundamental research in the last 15 years, this group has identified and clinically-validated numerous CIN2+-specific tumor-suppressor genes deregulated by DNA hypermethylation. They reported that DNA methylation status of these genes has predictive value whether or not cervical cancer or its precursors are present in cervical scrapings. Therefore, these CIN2+-specific methylation markers might be of relevance in the early detection of cervical cancer. The methylation assay consists of a balanced combination of the probes and primers of the three best performing methylation markers in a multiplex test kit.
CC Diagnostics selected the best 3 genes that, using the methylation assay as a triage test, generate an 81% specificity, which outperforms any triage test available, regardless which primary test has been used.
Using the methylation assay as a triage test, this combination of genes showed a sensitivity of 77%, which is comparable with the sensitivity of HPV test (79%).
The DNA methylation test is compatible with a quantitative PCR platform. The quantitative polymerase chain reaction (qPCR) technique is commonly used in all ISO-certificated labs.