INDUSTRY WORKSHOP: Advancing Standardization in Therapeutic Drug Monitoring: From Metrology Concepts to Industry Solutions
Tracks
Track 1
| Tuesday, September 23, 2025 |
| 12:30 PM - 1:25 PM |
| Grand Copthorne Waterfront Hotel - Grand Ballroom foyer |
Overview
Delivered by: Roche Diagnostics
Details
Disclaimer:
cobas Ⓡ i 601 analyzer and Ionify Steroids 1 and Vitamin D reagent packs are CE-marked. Further Ionify reagents are still under development. These products are not cleared or available for use in the US. COBAS and IONIFY are trademarks of Roche. This study was funded by Roche Diagnostics
GmbH, Mannheim.
Research funding: This research was funded by Roche Diagnostics GmbH.
Speaker
Dr Christoph Sager
Labordiagnostic St. Gallen West AG
ISD standardization - from early challenges towards a solution
Abstract
Dr. Seger will discuss the evolution of immunosuppressant therapeutic drug monitoring (ISD-TDM) from early immunoassays, which lacked specificity and metrological traceability, to LC-MS/MS, which improved analyte specificity but faced challenges due to variations in local test developments. The introduction of commercial LC-MS/MS calibrators and the establishment of a JCTLM reference measurement procedure (RMP) for ISDs have significantly advanced standardization. While challenges remain, such as the need for primary reference materials and
measurement services, ongoing efforts in RMP development and standardization are paving the way for full traceability and improved patient care.
measurement services, ongoing efforts in RMP development and standardization are paving the way for full traceability and improved patient care.
Biography
Dr. Christoph Seger, FAMH, EuSpLM, is a habilitated chemist with 20+ years’ experience in laboratory medicine. Christoph Seger originally worked in university research and has held various management positions in university and private laboratories during his career. He currently holds a management board and CMO position in his Swiss laboratory business LDSGW. The major focus of his research activities is the development of new analytical methods for the fields of TDM and toxicology. These activities have led to 150+ publications and extensive lecturing activities. Christoph Seger served the IFCC as head of the joint IATDMCT/IFCC working group on immunosuppressants (WG-ID).
Judith Taibon, PhD
Team Lead MS and Separation Technologies
Roche Diagnostics GmbH,
Metrology in TDM: from academic concepts to IVD-industry support
Abstract
In this session, Dr. Taibon will discuss Roche’s commitment to advancing metrological traceability in therapeutic drug monitoring (TDM) through the development of reference measurement procedures (RMPs). When initiating development of a fully automated LC-MS/MS
platform, the absence of suitable primary reference materials (PRM) and RMPs for many analytes posed a significant challenge. Recognizing the clinical importance of traceability, Roche has invested in developing RMPs across its portfolio in collaboration with academic institutions and clinical laboratories. These efforts have already led to multiple JCTLM-listed
RMPs, with further developments for all Roche TDM analytes underway.
platform, the absence of suitable primary reference materials (PRM) and RMPs for many analytes posed a significant challenge. Recognizing the clinical importance of traceability, Roche has invested in developing RMPs across its portfolio in collaboration with academic institutions and clinical laboratories. These efforts have already led to multiple JCTLM-listed
RMPs, with further developments for all Roche TDM analytes underway.
Biography
Since joining Roche Diagnostics in 2016, Dr. Taibon has been a team lead in the department of instrumental analytics at Roche Diagnostics. She is responsible for the development of reference measurement procedures used to standardize Roche's internal products. In her role, she works closely with internal and external stakeholders and is involved in various committees that focus on the implementation of traceability by IVD manufacturers.
