Professional Documents
Culture Documents
Severity of damge
Remained DROP
Emerging Markers
Criteria for novel biomarkers
• Novel biomarkers have to clear a high hurdle to be
adopted in clinical practice. Numerous experts have
proposed criteria or features for evaluating the utility of
cardiac biomarkers.
Measurability
•Does the biomarker measure a specific pathology with
known reference limits and high myocardial specificity?
•Can the marker be measured with high accuracy, precision,
and reproducibility?
•Does the biomarker have high sensitivity and specificity?
•Are results available with high throughput and short
turnaround time?
•Can the biomarker be measured at reasonable cost?
•Have pre-analytical issues been evaluated and are
measurable—is the marker stable?
Patient
Incremental Value
Management
Has a linear relationship Patient Impact
between a change in the
marker and a change in •Does a change in the marker alter
pathology been patient management?
demonstrated in multiple •Is there evidence that biomarker-
studies? guided triage or monitoring improves
•Is the marker superior care?
to existing tests in •Does the marker aide in selecting
predicting risk, therapy, stratifying risk, monitoring
diagnosing disease response to therapy or disease
earlier, or correlating progression, detecting sub-clinical
with disease? disease?
•Have the decision limits
been validated in more •Will knowledge of the test result
than one study? bring better patient understanding of
their disease or risk?
•Has the marker been
•Will knowledge of the test result
evaluated in diverse prompt healthier patient behaviors?
populations?