Professor Dr. Uwe Oelmueller
Title of Presentation
Standardized improved pre-analytical workflows: the key to good quality samples for reliable diagnostics and research
Date and Place
Dr. Uwe Oelmueller joined QIAGEN in 1995. He is currently heading the technology center ”Sample Technologies” within the global Molecular Diagnostics Development Department. The center involves technology and product development projects for clinical sample collection, cellular biomolecule profile preservation, sample storage, transport and archiving, as well as for the isolation and analysis of human and pathogen nucleic acids. At the QIAGEN / Becton Dickinson joint venture company PreAnalytiX he is QIAGEN’s management committee co-chair. PreAnalytiX develops and sells integrated and standardized systems covering all pre-analytical workflow steps. Dr. Oelmueller is the convener of the ISO/TC 212 (Clinical Laboratory Testing and In Vitro Diagnostic Test Systems) Working Group 4 focusing on molecular diagnostics and microbiology. He is the deputy convener and a project leader of the CEN/TC 140 (In vitro Diagnostic Medical Devices) Working Group 3 currently focusing on pre-analytical workflows. He is the coordinator of the European FP7 Collaborative Grant Project SPIDIA and is involved in various other international consortia driving pre-analytical workflow improvements. Prior to QIAGEN, Dr Oelmueller headed a research group at the Clinical Microbiology Center, University of Goettingen, Germany, working on the AIDS disease stage relevant HIV RNA expression profile. Dr Oelmueller’s doctorate and diploma course research was at the Institute for Microbiology, University of Goettingen and analyzed the regulation of mRNA stability and processing in bacteria.
Molecular in vitro diagnostics and biomedical research have allowed great progress in medicine. Further progress is expected by new biomarker tests analyzing cellular biomolecule profiles such as nucleic acids, proteins, and metabolites. However, profiles of these molecules can change significantly during sample collection, transport, storage, archiving and processing, caused by post collection cellular changes such as gene inductions, gene down regulations, biomolecules modifications or degradation. This can make the outcome from diagnostics or research unreliable or even impossible because the subsequent analytical test will not determine the situation in the patient body but an artificial bioanalyte profile generated during the pre-analytical workflow. High quality clinical samples with preserved bioanalyte profiles are therefore critical to biobanking, research and diagnostics. The EU FP7 SPIDIA consortium could achieve significant progress by developing new pre-analytical workflow technologies and by generating evidence for developing new standard documents. The European Committee CEN/TC 140 “In vitro Diagnostic Medical Devices” has released first 9 Technical Specification documents to standardize pre-analytical workflows for different blood, other body fluids and tissue based molecular applications. They are currently under further development to International Standards within the ISO/Technical Committee 212 “Clinical Laboratory Testing and In Vitro Diagnostic Test Systems”. The presentation will give an overview about SPIDIA’s and thereon build other international project’s achievements as well as a future perspective.