Exploratory Biomarker Assays: Key Assay Parameters to Evaluate in the Face of Evolving Biomarker Context-of-Use

Discovery proteomics research has made significant progress in the past several years; however, the number of protein biomarkers deployed in clinical practice remains rather limited. There are several scientific and procedural gaps between discovery proteomics research and clinical implementation, which have contributed to poor biomarker validity and few clinical applications. The complexity and low throughput of proteomics approaches have added additional barriers for biomarker assay translation to clinical applications. Recently, targeted proteomics have become a powerful tool to bridge the biomarker discovery to clinical validation. In this perspective, we discuss the challenges and strategies in proteomics research from a clinical perspective, and propose several recommendations for discovery proteomics research to accelerate protein biomarker discovery and translation for future clinical applications.

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Calibrator Material Selection: A Key Criteria During Biomarker Assay Method Development

Thankamony

Liu

Peterson

et al. 2021

Bioanalysis

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Biomarker assay method development is a multistep rigorous process and calibrant material selection is integral to ensuring the quality of such assays. However, the impact of selection of calibrator material may often get overlooked. In this article, we highlight three case studies where biomarker calibrant material selection was deemed an essential criterion for consideration. Through these case studies we highlight challenges faced, steps taken and discuss the impact on assay-related decision-making. We also provide additional perspectives for selection and characterization of calibrant proteins in the setting of an evolving biomarker context of use.

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Exploratory Biomarker Assays: Key Assay Parameters to Evaluate in the Face of Evolving Biomarker Context-of-Use

Abstract: An exciting set of data can transform interest in an early exploratory biomarker into a key consideration for program-related decision-making "

Cited by 4 publications

References 9 publications

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Calibrator Material Selection: A Key Criteria During Biomarker Assay Method Development

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