Daphne Hessels

Background

About Daphne Hessels

After obtaining my BSc degree in Biochemistry at the Hogere Laboratorium School (HLO) in Nijmegen, I started my career at the Radboud University Nijmegen Medical Centre (RUNMC) at the department of Urology. Under the supervision of prof dr Jack A. Schalken I was a member of the team that was involved in the discovery, characterization and validation of the diagnostic potential of PCA3, a biomarker for prostate cancer. The translation of PCA3 from bench to the clinic has resulted in a number of peer-reviewed publications and eventually my PhD degree in 2010. Besides my research activities, I have been a teacher in the Master Class Study Program of Molecular Mechanisms of Disease and the Biomedical Science program at the RUNMC and I was a coordinator in European study programs such as BIOMED II and the P-MARK study. I have presented the research at several national and international meetings. At NovioGendix, a spin-off company of the RUNMC, I was involved in the discovery and development of a molecular diagnostic test for a new candidate gene panel for high-grade prostate cancer from 2008-2015. After acquisition of NovioGendix by MDxHealth, this test was brought to the market under the tradename SelectMDx for Prostate Cancer. At MDxHealth I was responsible for the laboratory set-up, laboratory management and quality management of the service testing facility for which the ISO 13485:2016 certification was obtained. I coordinated clinical European validation studies in my role as Director Research and Medical Affairs, contributed to a number of peer-reviewed publications of the company, and presented research findings at national and international meetings. As RA and Medical Scientific Affairs manager I was responsible for writing and preparing the Technical Files for CE-marking according to the IVDR. After 25 years of working in the field of oncology and bringing two molecular diagnostic tests from bench to bedside, I was ready for a new challenge. My new role as Medical Device Auditor and Technical File reviewer at DEKRA Certification in Arnhem gives me the opportunity to apply and expand my knowledge and skills to guard safety and performance of (in vitro diagnostic) Medical Devices on the market.