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It is necessary to distinguish between disease-related and drug-related biomarkers.Disease-related biomarkers give an indication of the probable effect of treatment on patient (risk indicator or predictive biomarkers), if a disease already exists (diagnostic biomarker), or how such a disease may develop in an individual case regardless of the type of treatment (prognostic biomarker).
In biomedical contexts, a biomarker, or biological marker, is a measurable indicator of some biological state or condition. Biomarkers are often measured and evaluated using blood, urine, or soft tissues [1] to examine normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. [2]
Medical biomarkers fall into 5 major categories: 1) diagnostic (used to identify if you have a disease or condition); 2) prognostic (used to determine how well you will do with the disease or condition); 3) predictive (used to determine if you may get the disease); 4) efficacy or monitoring (used to determine how well a drug or treatment is ...
Biomarker discovery is a medical term describing the process by which biomarkers are discovered. Many commonly used blood tests in medicine are biomarkers. There is interest in biomarker discovery on the part of the pharmaceutical industry; blood-test or other biomarkers could serve as intermediate markers of disease in clinical trials, and as possible drug targets.
However, successful biomarker surrogates could save substantial time, effort, and money if failing drugs could be eliminated from the development pipeline before being brought to clinical trials. Some ideal characteristics of surrogate endpoint biomarkers include: [43] [44] Biomarker should be involved in process that causes the cancer
A clinical trial may show that a particular drug (for example, simvastatin (Zocor)) is effective in reducing cholesterol, without showing directly that simvastatin prevents death. Proof of Zocor's efficacy in reducing cardiovascular disease was only presented five years after its original introduction, and then only for secondary prevention . [ 9 ]
A companion diagnostic (CDx) [1] is a diagnostic test used as a companion to a therapeutic drug to determine its applicability to a specific person. [2]Companion diagnostics are co-developed with drugs to aid in selecting or excluding patient groups for treatment with that particular drug based on their biological characteristics that determine responders and non-responders to the therapy.
An imaging biomarker is a biologic feature, or biomarker detectable in an image. [1] In medicine, an imaging biomarker is a feature of an image relevant to a patient's diagnosis. For example, a number of biomarkers are frequently used to determine risk of lung cancer .