Typically, a test is evaluated against a reference diagnosis to calculate clinical sensitivity, i.e., the fraction of people with disease who test positive, and specificity, i.e., the fraction of people without the disease who test negative. The importance of accurate diagnosis warrants assessment of the clinical performance of diagnostic biomarker tests. Diagnostic biomarkers that identify disease subtypes thus often play critical roles when the results of diagnostic classification can be used as prognostic biomarkers and predictive biomarkers. Genetic markers are often used to distinguish responders and non-responders to cancer treatments. Pathophysiologic markers, such as decreased or preserved ejection fraction in heart failure, can predict who will respond to specific treatments i.e., it is a predictive biomarker. Various genetic markers, for example, can predict the likelihood of breast cancer recurrence after surgical tumor removal, i.e., they are prognostic biomarkers. As is becoming increasingly appreciated, many diseases have subtypes with markedly different prognoses or responses to a specific treatment.
PREDICTIVE VS PROGNOSTIC BIOMARKERS TRIAL
Diagnostic biomarkers are used for the critical determination of whether a patient has a particular medical condition for which treatment may be indicated or whether an individual should be enrolled in a clinical trial studying a particular disease. Medical practice requires accurate diagnosis of diseases and conditions.
0 kommentar(er)
