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4.2 Evaluation of markers and technologies

Testing and evaluation of markers and technologies in humans for use in detection, diagnosis, prediction, prognosis and monitoring in clinical, community or applied settings including

  • assessment of sensitivity, efficacy, specificity, predictive and prognostic value, reproducibility and safety
  • medical devices, imaging, diagnostic and predictive tests
  • evaluation of diagnostic models, methods and methodologies in clinical or applied settings

Includes testing in humans, once verified in the laboratory, often in a trial or studies that involve a group of people.