The Biomarker Center received a new seal of quality in June 2020. Following successful certification by TÜV Rheinland, a quality management system was established in accordance with ISO 9001:2015 under the direction of Professor Friedemann Horn, Dr Conny Blumert (Next-Generation Diagnostics Unit) and Dr Kristin Reiche (Bioinformatics Unit).
In the Biomarker Center, new diagnostic and prognostic RNA biomarkers are systematically and comprehensively identified and validated using cutting-edge technologies such as next generation sequencing (NGS). Expertise in managing studies and data is essential when it comes to planning and arranging clinical cohorts as well as handling clinical and experimental data. The biomarker screening process is also being optimized and perfected with the aid of technical innovations. Since June 2020, the procedures involved here have been governed by a certified quality management system (ISO 9001:2015).
The TÜV certificate specifically covers: “Research and commissioned work in the field of molecular diagnostic analytics and the related bioinformatic evaluation, with emphasis on personalized medicine as well as optimizing and developing modern processes and applications for molecular diagnostics including next generation sequencing”. The appraised quality management system ensures that internal operations, service quality, and partner and customer relationships are all overseen by a quantifiable system at the Biomarker Center. This means that processes are mapped precisely, their efficiency increased, and internal errors reduced. Process validation is another important aspect at the Biomarker Center. If a process is documented, evidence can always be provided to show that it fulfills the demands placed on a particular service and that it delivers reliable, transparent results. This enables competitive research and development projects to be driven forward together with clinical partners and interested research partners.