In the western world, 10 million triage tests are performed in cervical cancer screening programs on an annual basis. In Europe, almost one million women are falsely diagnosed with having cervical cancer with the use of today’s available tests. This leads to an annual financial burden of €360 million per year for the European society and severe psychological distress for the woman. Implementation of the CC Diagnostics’ methylation assay will decrease the number of false positives with 33%. As a result, we will save >€120 million of annual healthcare cost for the European society and prevent unneeded emotional stress for thousands of women.
CC Diagnostics collaborates with the research group of the UMCG. During 15 years of research, this group has identified unique tumor-suppressor genes. Small-scale validation of the best combination of genes show, using the methylation assay as a triage test, an 81% specificity and a 50% increase in reproducibility, which outperforms any triage test available, regardless which primary test has been used. CC Diagnostics will, in collaboration with the UMCG, validate this combination in a large-scale study with 3600 samples; results of this study are expected Q4 2019. CC Diagnostics holds an exclusive worldwide license on the patent.
In short, CC Diagnostics offers a superior, easily implementable triage test with an unsurpassed specificity and reproducibility, which will decrease the number of misdiagnosed women, decrease healthcare costs, and increase screening participation.
Besides the UMCG as launching hospital, the four other laboratories in the Netherlands will be targeted for pilot use, followed by Southern European countries with a privatised market and high screening rate (once per year) such as Northern Spain and Northern Italy. Next step will be implementation in national screening programs in Europe, i.e. The Netherlands. To complete clinical validation of the technology and preparing the product and company for its first sales, CC Diagnostics needs an investment of €1.15 million.