Biomarkers and the Clinical labortatory

• What is a biomarker?

  A characteristic that is objectively measured and evaluated as an indicator of biological processes.
• What are diagnostic biomarkers used for?

  To detect disease early and classify disease type.
• What is the purpose of predictive biomarkers?

  To identify likely responders and those likely to have an adverse event.
• How do metabolism biomarkers assist in drug therapy?

  They aid in defining drug doses.
• What do outcome biomarkers indicate?

  Response to therapy, indication of progression, and evidence of recurrence.
• What is the role of the diagnostics industry in biomarker development?

  • Turns concepts into practical tools
  • Collaborates with clinical biochemistry laboratories
  • Evaluates tools in real-life practice
• What is the time frame for moving biomarkers from research to routine use?

  Often years.
• What are the responsibilities of research laboratories in biomarker development?

  To undertake validation of assay performance and provide clinical data.
• What is meant by assay performance in biomarker research?

  It includes reproducibility, detection limit, accuracy, and robustness.
• What is the detection limit in biomarker assays?

  The lowest reportable concentration.
• Why is it important to investigate pre-analytical requirements early in biomarker research?

  To ensure specimen quality and reliability of results.
• What are some examples of pre-analytical requirements for biomarker testing?

  Specimen type, timing, and storage requirements.
• What defines a specialist assay in biomarker testing?

  Small workload, rare clinical conditions, or complex clinical interpretation.
• What are the early requirements for introducing a new routine test?

  Evidence that the test improves patient management and a business case for funding.
• What are the pre-analytical requirements for introducing a new routine test?

  No special handling required, good stability, and awareness of medication effects.
• What is the workload of the Clinical Biochemistry lab at the Royal Infirmary?

  ~800,000 samples/year and ~5 million tests in total.
• How does sample reception work in the Clinical Biochemistry lab?

  Specimens are barcoded during the booking-in process.
• What are the analytical considerations for introducing a new test?

  Automation, internal quality control, and external quality assessment must be in place.
• What is the process of sample analysis in a modern hospital lab?

  Samples are sorted, analyzed, and results are uploaded for checking.
• What are the conclusions regarding the introduction of new biomarkers?

  • Evidence supports clinical utility
  • Funding can be assured
  • Automation is feasible for high workloads
  • Quality is verified through IQC and EQA
• What mechanisms should be in place for new biomarker tests?

  To ensure tests are done only for those likely to benefit.