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

被引：0
|
作者：
van Waalwijk van Doorn-Khosrovani, Sahar Barjesteh [1 ,2 ]
Van Criekingen, Olga Kholmanskikh [3 ]
Koole, Simone [4 ]
Thomas, David M. [5 ]
Gelderblom, Hans [1 ]
机构：
[1] Leiden Univ, Med Ctr, Dept Med Oncol, Leiden, Netherlands
[2] CZ Hlth Insurance, Med Dept, Tilburg, Netherlands
[3] Belgian Fed Agcy Med & Hlth Prod FAMHP, Brussels, Belgium
[4] Zilveren Kruis, Med Advisory Dept, Zeist, Netherlands
[5] Univ New South Wales, Ctr Mol Oncol, Sydney, NSW, Australia
来源：
CANCER CELL | 2024年 / 42卷 / 06期
关键词：
HOMOLOGOUS RECOMBINATION DEFICIENCY;
D O I：
10.1016/j.ccell.2024.05.014
中图分类号：
R73 [肿瘤学];
学科分类号：
100214 ;
摘要：
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.
引用
收藏
页码：923 / 929
页数：7
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