Testing dilemmas in the clinic: Lessons learned from biomarker-based drug development.

Various tests based on different biomarkers have been developed to identify the best candidates for poly(ADP-ribose) polymerase (PARP)-inhibitor therapy. However, due to the absence of harmonization regarding these complex biomarkers, along with various cutoff points and unknown spatial and temporal variations, it is difficult to define the clinical utility of each test and ensure uniformity in treatment decision-making. Here, we propose measures to align biomarker definitions and minimum analytical performance characteristics for diagnostics to ensure equitable and sustainable access to precision medicine.

Informations de copyright

Copyright © 2024 Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests S.B.v.W.v.D.-K. is board member of the committee for long-term biomarker development of the KWF Dutch Cancer Society. Together with S.K. she sits on the National Funder’s Committee for Evaluation of Specialised Medicines and Companion Diagnostics (CieBAG). O.K.V.C. declares no competing interests, she is employed by the FAMHP and participates in the EMA activities. D.T. is the CEO of a non-profit company called Omico, which has established a national infrastructure for precision oncology. In that capacity Omico has contracts or research support from a number of commercial entities, including Roche, Astra Zeneca, Pfizer, Eisai, Illumina, Beigene, Elevation Oncology, RedX Pharmaceuticals, SunPharma, Bayer, Abbvie, Boehringer Ingelheim, Servier, George Clinical, Novotech, Avance, Janssen, Merck, Kinnate, Microba, BioTessellate, Australian Unity, Foundation Medicine, and Sonic Health. The personal views and opinions expressed in this publication are those of the individual authors and may not be understood or quated as being made on behalf of or reflecting the position of any organization or working group with which the authors are affiliated, the European Medicines Agency, or any of its scientific committees or working parties.