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CASUS

Introduction

Self-screen and Novosanis have obtained a Eurostar grant named CASUS, which is part of the Horizon 2020 Framework Program. The CASUS project is meant to develop a complete cervical cancer screening solution based on first-void urine self-sampling. The development is done in cooperation with two academic partners, University of Antwerp and Amsterdam UMC (Vrije Universiteit Amsterdam). The method will include the Colli Pee urine collection device from Novosanis and HPV and methylation CE-IVD tests from Self-screen.

Project goal

Although HPV-induced CC is preventable and treatable if detected in an early stage, it is the second biggest cancer killer of women aged 30-65. Most EU countries screen for CC, but participation is low due to the need to visit a physician and the uncomfortable nature of the procedure. With over 21 million women eligible for screening annually the EU-28 presents a major market opportunity for a diagnostic approach aimed at increasing attendance, by allowing women to self-collect urine at home. With the CASUS project we will develop the first complete molecular screening solution for cervical cancer (CC), based on standardized self-collected first-void urine to maximize screening participation throughout the EU. CASUS will result in a next-generation user-friendly first-void urine collector, combined with an integrated diagnostic approach  for 1) detection of human papillomavirus (HPV) infection and 2) triage after a HPV+ result to identify women with CC or precursor lesions in need of colposcopy.

Work packages

Work package 1 will include the development of the next generation of Colli-Pee first-void urine sampler, allowing smaller sample volumes. This WP will determine the optimal volume range for the detection of viral and host biomarkers and for clinical performance.

Work package 2 will include the selection of the most optimal methylation marker panel for the detection of cervical cancer in urine and the development of a multiplex quantitative methylation specific PCR (qMSP) which will be used in work package 3 and 4.

Work package 3 and 4 comprehends the validation of HPV-Risk and PreCursor-U+ for detection of cervical carcinoma and CIN3. Urine samples will be collected with the Colli Pee developed in WP1 in clinical studies set up by University of Antwerp and Amsterdam UMC (Vrije Universiteit Amsterdam).

Work Package 5 focuses on general project management, market implementation research and reimbursement strategy.