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Related Experiment Video

Updated: Mar 18, 2026

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
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Biomarker development targeting unmet clinical needs.

Phillip J Monaghan1, Sarah J Lord2, Andrew St John3

  • 1Department of Clinical Biochemistry, The Christie Pathology Partnership, The Christie NHS Foundation Trust, Manchester, UK.

Clinica Chimica Acta; International Journal of Clinical Chemistry
|July 5, 2016
PubMed
Summary

A new checklist helps identify unmet clinical needs for biomarkers, ensuring tests are used effectively. This strategy promotes efficient biomarker development and clinical integration.

Keywords:
BiomarkerChecklistClinical pathwayMedical testsUnmet needs

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Area of Science:

  • Biomarker Discovery and Validation
  • Clinical Laboratory Science
  • Health Services Research

Background:

  • New biomarker introduction risks inappropriate test utilization if clinical needs are unmet.
  • A defined strategy is crucial for identifying genuine gaps in clinical care that biomarkers can address.

Purpose of the Study:

  • To develop a strategy and a comprehensive checklist for identifying unmet needs for biomarker testing.
  • To ensure new biomarkers address specific clinical care gaps and improve patient outcomes.

Main Methods:

  • A multidisciplinary working group employed a four-step process: literature review, consensus meetings, iterative feedback, and case scenario testing.
  • Clinical pathway mapping was utilized to link biomarker testing decisions to health outcomes.

Main Results:

  • A 14-item checklist, structured into four domains (identifying/verifying unmet need, validating intended use, assessing feasibility), was developed.
  • The checklist provides an outcome-focused approach applicable to various medical tests and stakeholders.

Conclusions:

  • The developed checklist aims to enhance the efficiency of biomarker development and clinical translation.
  • Field testing by stakeholders and collaboration involving clinical laboratory professionals are advocated for successful implementation.