The use of biomarkers in basic and clinical research as well as in clinical practice has become so commonplace that their presence as primary endpoints in clinical trials is now accepted almost without question. Medical signs have a long history of use in clinical practice—as old as medical practice itself—and biomarkers are merely the most objective, quantifiable medical signs modern laboratory science allows us to measure reproducibly.
Definition of Biomarkers
A biomarker, or biological marker generally refers to a measurable indicator of some biological state or condition. It is a biological characteristic, which can be molecular, anatomic, physiologic, or biochemical. These characteristics can be measured and evaluated objectively. They act as indicators of a normal or a pathogenic biological process. They allow assessing the pharmacological response to a therapeutic intervention. A biomarker shows a specific physical trait or a measurable biologically produced change in the body that is linked to a disease or a particular health condition.
Potential biomarkers including proteins and protein fragments, metabolites, carbohydrate biomarkers, genomic biomarkers (RNA and DNA), cellular biomarkers (captured as the cell pellet from body fluids), and imaging biomarkers. These types of biomarkers can also be referred to as in vitro biomarkers (derived from in vitro diagnostics) versus in vivo biomarkers respectively. A biomarker may be used to assess or detect a specific disease as early as possible, the risk of developing a disease, the evolution of a disease and it can be predictive too.
Biomarkers can take a wide variety of forms. For example, some biomarkers can be used to indicate the presence of certain organisms, including a history of their presence even if they no longer exist. A classic example of such a biomarker is an antibody, a substance developed by the body to help it fight disease. Biomarkers can also be used to differentiate cells; some cancer treatments, for example, are designed to target specific cells, using their biomarkers like a tag.
Functions of Biomarkers
Biomarkers assays are becoming increasingly important in clinical development. Biomarker assays are also useful for identifying intermediate endpoints of success to decrease follow-up time. The use of a specific biomarker assay can provide early indication of drug efficacy.
Biomarkers depicting prodromal signs enable earlier diagnosis or allow for the outcome of interest to be determined at a more primitive stage of disease. Blood, urine, and cerebrospinal fluid provide the necessary biological information for the diagnosis. In these conditions, biomarkers are used as an indicator of a biological factor that represents either a subclinical manifestation, stage of the disorder, or a surrogate manifestation of the disease. Biomarkers used for screening or diagnosis also often represent surrogate manifestations of the disease.
Biomarkers and Diseases
Since at least the 1980s, the necessity of using biomarkers as surrogate outcomes in large trials of major diseases, such as cancer and heart disease, has been widely discussed. Factors such as increasing prevalence of cancer and heart desease, increased awareness and acceptance of diagnostic tests, Creative Diagnostics provides biomarkers related reagents.
| Cardiac Biomarker Antibodies | Cancer Biomarker Antigens |
| Cardiac Biomarker Antigens | Cancer Biomarker Elisa |
| Cardiac Biomarker Elisa |
Biomarkers play a critical role in improving the drug development process as well as in the larger biomedical research enterprise. Understanding the relationship between measurable biological processes and clinical outcomes is vital to expanding our arsenal of treatments for all diseases, and for deepening our understanding of normal, healthy physiology.