Test design
Challenge
Cervical cancer prevention is possible through the detection of the Human Papillomavirus (HPV), the causal agent of cervical cancer. But whereas high sensitivity is a key advantage of HPV DNA testing, its specificity for cervical pre-cancer and cancer is limited: most HPV infections are cleared and are not associated with risk for developing invasive carcinoma.
Moreover, several studies performed on commercially-available HPV DNA detection assays show that approximately 30%–50% of positive cases show discordance in the specific HPV infection detected. This may be related to the viral target sequence selected for detection: genetic variability of the HPV genome might interfere and this might be even more pronounced when testing women from different ethno-geographic origins because specific HPV variants are associated with different patient origins. These findings challenge the assumption that commercially-available HPV DNA tests are capable of preventing and detecting cervical cancer in all women worldwide.
Solution
The ELEVATE project will sequence the DNA of 14 high risk HPV types and verify the genomic variation by using samples collected among hard-to-reach women in Belgium, Brazil, Ecuador and Portugal to ensure diversity of patients from different ethno-geographic origins. Based on these results, the ELEVATE project will develop a test that will be designed for a possible global implementation. Simultaneously, the ELEVATE project will develop a test to detect proteomic biomarkers expression. Positive cases for both tests (genomic and proteomic) should be considered high-risk cases for cancer development and should be referred to treatment whereas single positives should be closely followed to monitor possible disease progression.