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Valid screen

Introduction

Self-screen has acquired a prestigious SME Instrument grant in the Horizon 2020 program from the European Commission. In the project, named Valid-screen, a large clinical validation study with the QIAsure Methylation Test is conducted. The project is the largest SME grant that was awarded to a Dutch SME.

Project goals

Supplementing HPV screening with the methylation assay will enable physicians to assess whether the HPV infection is progressing toward cancer; a valuable insight that will provide guidance to follow-up procedures, reducing overdiagnosis and overtreatment. The markers of the QIAsure Methylation Test have been separately evaluated in clinical settings, and the combined marker panel has been validated in laboratory and small-scale clinical settings with desired clinical sensitivity and specificity. Divided over six work packages, the Valid-screen project will further test and validate the clinical performance of the methylation assay in HPV-positive women. Independent subcontractors from different European countries will test and validate the assay in historical, prospectively collected screening cohorts and gynaecological outpatient referral populations with known clinical follow up. The project will furthermore tackle important market implementation aspects. Altogether, the study will provide essential clinical performance data of the methylation assay in European screening and gynaecologic outpatient setting, and deliver a key diagnostic tool in the cancer detection area to advance women’s health. This can be adopted in the screening programs of the different EU countries for improved prevention and early detection of cervical cancer.

Work packages

The first three work packages include the clinical validation experiments to provide the proof for clinical utility as a triage test for HPV-positive women (WP1), a diagnostic test for young HPV-positive gynaecological outpatients (WP2), and an extremely sensitive test for cervical cancer (WP3). To enable market implementation, the project includes a health need assessment and a cost-benefit analysis (WP4). WP5 and WP6 ensure that proper attention is given to project management, dissemination of results and aspects related to ethics and exploitation.

Project completion

In May 2019 all deliverables and reports were submitted and the project was closed. The project was successfully delivered according to EU Horizon2020 guidelines and the expert reviewer came to a 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.