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Updated: Jan 3, 2026

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Targeted and Untargeted Proteomics Approaches in Biomarker Development
Constance A Sobsey1, Sahar Ibrahim1, Vincent R Richard1
1Segal Cancer Proteomics Centre, Lady Davis Institute, Jewish General Hospital, McGill University, Montreal, Quebec, H3T 1E2, Canada.
Successful biomarker development relies on a "fit-for-purpose" strategy, integrating untargeted proteomics for discovery and targeted approaches for validation. This review explores optimizing proteomic biomarker research for clinical application.
Area of Science:
- Biochemistry
- Molecular Biology
- Clinical Diagnostics
Background:
- Extensive research focuses on biomarker discovery and validation.
- Proteomics is increasingly vital for identifying novel biomarkers post-human genome completion.
Purpose of the Study:
- Review key factors for successful biomarker development.
- Apply these factors to proteomic biomarker research.
- Discuss challenges and future directions for MS-based proteomics in clinical settings.
Main Methods:
- Systematic screening of published articles on MS-based proteomics for biomarker development.
- Analysis of targeted versus untargeted proteomic approaches.
Main Results:
- Both targeted and untargeted proteomic technologies are employed in biomarker development.
- A significant gap exists as most studies do not combine these approaches.
- The "fit-for-purpose" strategy is crucial for effective biomarker development.
Conclusions:
- Integrating untargeted proteomics for discovery and targeted proteomics for validation is recommended.
- Addressing technical challenges is essential for translating proteomic biomarkers into clinical practice.
- Mass spectrometry (MS) holds potential to enhance, complement, or replace existing clinical assays.
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