What is a biomarker? It’s time for a renewed definition
-
Xavier Fuentes-Arderiu
Usually Clinical Chemistry and Laboratory Medicine publishes articles related to the advances in biomarkers. The review on statistics and medical usefulness of biomarkers [1] and an editorial [2] published in this journal are clear examples of this. However, in the mentioned review, as in many other articles, the term “biomarker” is used with two meanings: 1) a biomarker is a component (analyte) of a human biological system (i.e., plasma, urine, etc.); or 2) a biomarker is a biological property (i.e., mass concentration of X in plasma).
The Biomarkers Definitions Working Group gave an international definition of biomarker for the field of pharmacological clinical trials: “a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention” [3]. However, in spite of this definition, the ambiguity described in the preceding paragraph is common in health sciences publications and in the in vitro diagnostics industry literature.
It is terminologically obvious that a scientific term should designate only one concept. Thus, the recommendation of a general and unique definition and the adherence to this recommendation would be very welcomed. It would be reasonable that this definition was written by Nomenclature, Properties, and Units, the joint group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), and the International Union of Pure and Applied Chemistry (IUPAC) devoted but not limited to these kind of affairs, but in the meantime the following definition of biomarker (or simply marker) might be provisionally used: “human or animal biological property whose in vitro measurement or identification is useful for the prevention, diagnosis, prognosis, treatment, and follow-up of human or animal diseases, and for their understanding”.
As a final clarification, it should be kept in mind that in the field of clinical pharmacology (clinical trials) the concept of “biomarker” has a wider meaning than in clinical laboratory sciences: some biomarkers are in vitro measured or identified and others in vivo. In the field of clinical laboratory sciences, as reflected in the proposed definition, the concept of “biomarker” is always related to in vitro measurements or identifications.
Conflict of interest statement
Author’s conflict of interest disclosure: The author stated that there are no conflicts of interest regarding the publication of this article.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Disclaimer: The author is a member of the joint group of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), and the International Union of Pure and Applied Chemistry (IUPAC) on Nomenclature, Properties, and Units, and a member of the Joint Committee on Guides for Metrology (JCGM), Working Group 2 (VIM). The opinions and proposal expressed in this article do not necessarily represent the view of the IFCC-IUPAC or JCGM.
References
1. Pencina MJ, D’Agostino RB, Vasan RS. Statistical methods for assessment of added usefulness of new biomarkers. Clin Chem Lab Med 2010;48:1703–11.10.1515/CCLM.2010.340Suche in Google Scholar PubMed PubMed Central
2. Plebani M. Lessons from controversy: biomarkers evaluation. Clin Chem Lab Med 2013;51:247–8.10.1515/cclm-2013-0012Suche in Google Scholar PubMed
3. Biomarkers Definitions Working Group (National Institutes of Health). Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 2001;69:89–95.10.1067/mcp.2001.113989Suche in Google Scholar PubMed
©2013 by Walter de Gruyter Berlin Boston
Artikel in diesem Heft
- Masthead
- Masthead
- Editorials
- What is a biomarker? It’s time for a renewed definition
- Biomarker research and leading causes of death worldwide: a rather feeble relationship
- Thiosulfate in urine: new hope or new failure of a biomarker for prostate cancer?
- Review
- Acute coronary syndrome – the present and future role of biomarkers1)
- Mini Review
- Advance in molecular diagnostic tools for hepatitis B virus detection
- Opinion Paper
- Standardization and analytical goals for glycated hemoglobin measurement
- Guidelines and Recommendations
- Proposal for the use in emergency departments of cardiac troponins measured with the latest generation methods in patients with suspected acute coronary syndrome without persistent ST-segment elevation
- General Clinical Chemistry and Laboratory Medicine
- Current status of verification practices in clinical biochemistry in Spain
- Two site evaluation of the performance of a new generation point-of-care glucose meter for use in a neonatal intensive care unit
- Trp64Arg (rs4994) polymorphism of β3-adrenergic receptor gene is associated with hyperuricemia in a Chinese male population
- Quantification of vancomycin in human serum by LC-MS/MS
- Automated indirect immunofluorescence antinuclear antibody analysis is a standardized alternative for visual microscope interpretation
- Autocorrelation and cross-correlation between hCGβ and PAPP-A in repeated sampling during first trimester of pregnancy
- Platelet oxidative stress and systemic inflammation in chronic spontaneous urticaria
- Reference Values
- Establishment of reference values for novel urinary biomarkers for renal damage in the healthy population: are age and gender an issue?
- Risks of mortality associated with common laboratory tests: a novel, simple and meaningful way to set decision limits from data available in the Electronic Medical Record
- Cancer Diagnostics
- Cancer antigen 125, human epididymis 4, kallikrein 6, osteopontin and soluble mesothelin-related peptide immunocomplexed with immunoglobulin M in epithelial ovarian cancer diagnosis
- Thiosulfate in urine as a facilitator in the diagnosis of prostate cancer for patients with prostate-specific antigen less or equal 10 ng/mL
- Anemia and iron biomarkers in patients with early breast cancer. Diagnostic value of hepcidin and soluble transferrin receptor quantification1)
- Sensitive detection of EML4-ALK fusion oncoprotein of lung cancer by in situ proximity ligation assay
- Re-evaluation of laboratory predictors of response to current anemia treatment regimens of erythropoiesis stimulating agents in cancer patients
- Cardiovascular Diseases
- Evaluation of four sensitive troponin assays for risk assessment in acute coronary syndromes using a new clinically oriented approach for comparison of assays
- A combined index of cardiac biomarkers as a risk factor for early cardiovascular mortality in hemodialysis patients
- Prognostic utility of biochemical markers of cardiovascular risk: impact of biological variability
- Letters to the Editors
- Exploring the relationship between serum biomarkers, acute intracerebral changes and outcome after severe traumatic brain injury (TBI)
- Laboratory false-positive results: a clinician responsibility or a shared responsibility with requesting clinicians?
- The one hour lactose tolerance test
- High concentration of IgM-κ paraprotein causes over-estimation of serum total protein by certain biuret method
- Determining calculated free testosterone reference intervals in a normal adult male population
- Alveolar neopterin, procalcitonin, and IL-6 in relation to serum levels and severity of lung injury in ARDS
- Falsely elevated cobalamin concentration in multiple assays in a patient with pernicious anemia: a case study
- Leading Figures in Laboratory Medicine
- Research forever – Klaus Jung
Artikel in diesem Heft
- Masthead
- Masthead
- Editorials
- What is a biomarker? It’s time for a renewed definition
- Biomarker research and leading causes of death worldwide: a rather feeble relationship
- Thiosulfate in urine: new hope or new failure of a biomarker for prostate cancer?
- Review
- Acute coronary syndrome – the present and future role of biomarkers1)
- Mini Review
- Advance in molecular diagnostic tools for hepatitis B virus detection
- Opinion Paper
- Standardization and analytical goals for glycated hemoglobin measurement
- Guidelines and Recommendations
- Proposal for the use in emergency departments of cardiac troponins measured with the latest generation methods in patients with suspected acute coronary syndrome without persistent ST-segment elevation
- General Clinical Chemistry and Laboratory Medicine
- Current status of verification practices in clinical biochemistry in Spain
- Two site evaluation of the performance of a new generation point-of-care glucose meter for use in a neonatal intensive care unit
- Trp64Arg (rs4994) polymorphism of β3-adrenergic receptor gene is associated with hyperuricemia in a Chinese male population
- Quantification of vancomycin in human serum by LC-MS/MS
- Automated indirect immunofluorescence antinuclear antibody analysis is a standardized alternative for visual microscope interpretation
- Autocorrelation and cross-correlation between hCGβ and PAPP-A in repeated sampling during first trimester of pregnancy
- Platelet oxidative stress and systemic inflammation in chronic spontaneous urticaria
- Reference Values
- Establishment of reference values for novel urinary biomarkers for renal damage in the healthy population: are age and gender an issue?
- Risks of mortality associated with common laboratory tests: a novel, simple and meaningful way to set decision limits from data available in the Electronic Medical Record
- Cancer Diagnostics
- Cancer antigen 125, human epididymis 4, kallikrein 6, osteopontin and soluble mesothelin-related peptide immunocomplexed with immunoglobulin M in epithelial ovarian cancer diagnosis
- Thiosulfate in urine as a facilitator in the diagnosis of prostate cancer for patients with prostate-specific antigen less or equal 10 ng/mL
- Anemia and iron biomarkers in patients with early breast cancer. Diagnostic value of hepcidin and soluble transferrin receptor quantification1)
- Sensitive detection of EML4-ALK fusion oncoprotein of lung cancer by in situ proximity ligation assay
- Re-evaluation of laboratory predictors of response to current anemia treatment regimens of erythropoiesis stimulating agents in cancer patients
- Cardiovascular Diseases
- Evaluation of four sensitive troponin assays for risk assessment in acute coronary syndromes using a new clinically oriented approach for comparison of assays
- A combined index of cardiac biomarkers as a risk factor for early cardiovascular mortality in hemodialysis patients
- Prognostic utility of biochemical markers of cardiovascular risk: impact of biological variability
- Letters to the Editors
- Exploring the relationship between serum biomarkers, acute intracerebral changes and outcome after severe traumatic brain injury (TBI)
- Laboratory false-positive results: a clinician responsibility or a shared responsibility with requesting clinicians?
- The one hour lactose tolerance test
- High concentration of IgM-κ paraprotein causes over-estimation of serum total protein by certain biuret method
- Determining calculated free testosterone reference intervals in a normal adult male population
- Alveolar neopterin, procalcitonin, and IL-6 in relation to serum levels and severity of lung injury in ARDS
- Falsely elevated cobalamin concentration in multiple assays in a patient with pernicious anemia: a case study
- Leading Figures in Laboratory Medicine
- Research forever – Klaus Jung
