Related Experiment Video
Updated: Jun 24, 2025

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
Published on: March 20, 2021
Testing dilemmas in the clinic: Lessons learned from biomarker-based drug development
Sahar Barjesteh van Waalwijk van Doorn-Khosrovani1, Olga Kholmanskikh Van Criekingen2, Simone Koole3
1Department of Medical Oncology, Leiden University Medical Centre, Leiden, the Netherlands; Medical Department, CZ Health Insurance, Tilburg, the Netherlands.
Standardizing complex biomarkers for poly(ADP-ribose) polymerase (PARP)-inhibitor therapy is crucial. This study proposes measures for harmonized definitions and performance standards to ensure equitable precision medicine access.
Area of Science:
- Biomarker Discovery and Validation
- Precision Medicine
- Oncology Diagnostics
Background:
- Multiple diagnostic tests exist for identifying patients eligible for poly(ADP-ribose) polymerase (PARP)-inhibitor therapy.
- Current biomarker testing lacks harmonization, featuring varied cutoff points and unaddressed spatial/temporal variations.
- This heterogeneity complicates the clinical utility assessment of individual tests and treatment uniformity.
Purpose of the Study:
- To propose standardized measures for biomarker definitions in PARP-inhibitor therapy selection.
- To establish minimum analytical performance characteristics for relevant diagnostic tests.
- To facilitate equitable and sustainable access to precision medicine.
Main Methods:
- Review and analysis of existing biomarker assays for PARP-inhibitor therapy.
- Development of a framework for harmonizing biomarker definitions.
- Proposal of minimum analytical performance standards for diagnostic tests.
Main Results:
- Identified key challenges in current biomarker testing for PARP inhibitors.
- Outlined a strategy for aligning biomarker definitions across different assays.
- Recommended specific performance criteria for diagnostic test validation.
Conclusions:
- Harmonization of biomarker definitions and analytical performance is essential for reliable PARP-inhibitor therapy selection.
- Standardized diagnostics will improve the clinical utility of tests and ensure consistent treatment decisions.
- Implementing these measures will promote equitable access to personalized cancer treatments.
Related Concept Videos
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Drug Discovery: Overview
Preclinical Development: Overview
Clinical Trials: Overview

