Valid-Screen for the clinical validation of QIAsure methylation assay.

Short description scope of the project e.g.

Under the SME instrument grant from the Horizon 2020 program, Self-screen and her independent European partners have completed the Valid-screen project, which is a large clinical validation study of the QIAsure Methylation assay in HPV positive women. In the scope of the project the markers of the QIAsure Methylation assay have been separately evaluated in clinical settings in prospectively collected screening cohorts to determine its clinical sensitivity, specificity and inter and intralaboratory reproducibility. The project tackles important market implementation aspects.

The Valid-screen project was completed in May 2019. The project was successfully delivered according to EU Horizon 2020 guidelines and the expert review came to the following very positive closing review report:

The beneficiary successfully completed all specific objectives of the project and the results obtained confirmed the clinical validity of the assay. All expected impacts described in the description of action of the project have been achieved. The data fully support the use of QIAsure Methylation Test as a triage test to distinguish the subgroup of HPV-positive women having a high risk of cervical (pre)cancer in need of further gynaecologic examination.

With this, the main goal of the project was accomplished.