生物マーカー

関: biochemical marker、biologic marker、biological marker、clinical marker、immune marker、immunologic marker、serum marker、surrogate end point、surrogate endpoint、surrogate marker

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出典(authority):フリー百科事典『ウィキペディア（Wikipedia）』「2016/01/08 09:32:41」(JST)

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A biomarker, or biological marker, generally refers to a measurable indicator of some biological state or condition. The term is also occasionally used to refer to a substance the presence of which indicates the existence of a living organism. Further, life forms are known to shed unique chemicals, including DNA, into the environment as evidence of their presence in a particular location.^[1]

Biomarkers are often measured and evaluated to examine normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. Biomarkers are used in many scientific fields.

History

The use of the term "biomarker" dates back to as early as 1980.^[2] In 1998, the National Institutes of Health Biomarkers Definitions Working Group defined a biomarker as "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]^[4]

Medicine

After a heart attack a number of different cardiac biomarkers can be measured to determine exactly when an attack occurred and how severe it was.

In medicine, a biomarker can be a traceable substance that is introduced into an organism as a means to examine organ function or other aspects of health. For example, rubidium chloride is used as a radioactive isotope to evaluate perfusion of heart muscle. It can also be a substance whose detection indicates a particular disease state, for example, the presence of an antibody may indicate an infection. More specifically, a biomarker indicates a change in expression or state of a protein that correlates with the risk or progression of a disease, or with the susceptibility of the disease to a given treatment.

Biochemical biomarkers are often used in clinical trials, where they are derived from bodily fluids that are easily available to the early phase researchers. A useful way of finding genetic causes of diseases such as schizophrenia has been the use of a special kind of biomarker called an endophenotype.

Other biomarkers can be based on measures of the electrical activity of the brain (using Electroencephalography (so-called Quantitative electroencephalography (qEEG)) or Magnetoencephalography), or volumetric measures of certain brain regions (using Magnetic resonance imaging) or saliva testing of natural metabolites, such as saliva nitrite, a surrogate marker for nitric oxide. One example of a commonly used biomarker in medicine is prostate-specific antigen (PSA). This marker can be measured as a proxy of prostate size with rapid changes potentially indicating cancer.

Biomarkers used for personalized medicine are typically categorized as either prognostic or predictive. An example is KRAS, an oncogene that encodes a GTPase involved in several signal transduction pathways. Prognostic biomarkers indicate the likelihood of patient outcome regardless of a specific treatment. Predictive biomarkers are used to help optimize ideal treatments, and indicates the likelihood of benefiting from a specific therapy. Biomarkers for precision oncology are typically utilized in the molecular diagnostics of chronic myeloid leukemia, colon, breast, and lung cancer, and in melanoma.^[5]

Biomarker regulatory validation

HER2 is the most popular validated biomarker. The measurement of HER2 status is used to predict breast cancer treatment responses

Proof of concept

Previously used to identify the specific characteristics of the biomarker, this step is essential for doing an in situ validation of these benefits. A large number of candidates must be tested to select the most relevant ones.^[6]

Experimental validation

This step allows the development of the most adapted protocol for routine use of the biomarker. Simultaneously, it is possible to confirm the relevance of the protocol with various methods (histology, PCR, ELISA, ...) and to define strata based on the results.

Analytical performances validation

One of the most important steps, it serves to identify specific characteristics of the candidate biomarker before developing a routine test. Several parameters are considered including:

sensitivity
specificity
robustness
accuracy
reproducibility^[7]

Protocol standardization

This optimizes the validated protocol for routine use, including analysis of the critical points by scanning the entire procedure to identify and control the potential risks.

Cell biology

In cell biology, a biomarker is a molecule that allows the detection and isolation of a particular cell type (for example, the protein Oct-4 is used as a biomarker to identify embryonic stem cells).^[8]

In genetics, a biomarker (identified as genetic marker) is a DNA sequence that causes disease or is associated with susceptibility to disease. They can be used to create genetic maps of whatever organism is being studied.

Geology and astrobiology

A biomarker can be any kind of molecule indicating the existence, past or present, of living organisms. In the fields of geology and astrobiology, biomarkers, versus geomarkers, are also known as biosignatures. The term biomarker is also used to describe biological involvement in the generation of petroleum.

Ecotoxicology

Biomarkers are used to indicate an exposure to or the effect of xenobiotics which are present in the environment and in organisms. The biomarker may be an external substance itself (e.g. asbestos particles or NNK from tobacco), or a variant of the external substance processed by the body (a metabolite) that usually can be quantified.

References

^ Zimmer, Carl (January 22, 2015). "Even Elusive Animals Leave DNA, and Clues, Behind". New York Times. Retrieved January 23, 2015.
^ Aronson, Jeffrey (2005). "Biomarkers and surrogate endpoints". British Journal of Clinical Pharmacology 59 (5): 491–494. doi:10.1111/j.1365-2125.2005.02435.x. PMC 1884846. PMID 15842546. Retrieved 17 July 2013.
^ Strimbu, Kyle; Jorge, Tavel (2010). "What are Biomarkers?". Current Opinion in HIV and AIDS 5 (6): 463–466. doi:10.1097/COH.0b013e32833ed177. PMC 3078627. PMID 20978388. Retrieved 17 July 2013.
^ "Biomarkers and surrogate endpoints: preferred definitions and conceptual framework.". Clinical Pharmacology & Therapeutics 69 (3): 89–95. 2001. doi:10.1067/mcp.2001.113989. PMID 11240971. Retrieved 17 July 2013.
^ Nalejska, Ewelina (2014). "Prognostic and Predictive Biomarkers". Molecular Oncology and Genetics 18: 273–284. |access-date= requires |url= (help)
^ "Proof-of-concept study of biomarker development in mice provides a roadmap for a similar approach in humans". www.fredhutch.org. Retrieved 2015-05-13.
^ "http://www.fda.gov/downloads/Drugs/NewsEvents/UCM300731.pdf" (PDF). www.fda.gov. Retrieved 2015-05-13. External link in |title= (help)
^ Biomarkers for Psychiatric Disorders. Publisher: Springer U.S. doi:10.1007/978-0-387-79251-4 Copyright: 2009 ISBN 978-0-387-79250-7 (Print) 978-0-387-79251-4 (Online)

External links

Geomarkers versus biomarkers: Paleoenvironmental and astrobiological significance
Henry Stewart Talks Biomarkers Series The path forward to highly sensitive and specific molecular diagnostics.

UpToDate Contents

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English Journal

Analysis of MicroRNA expression profile identifies novel biomarkers for non-small cell lung cancer.

Xu C1, Zheng Y, Lian D, Ye S, Yang J, Zeng Z.
Tumori.Tumori.2015 Post author correction;0(0):0. doi: 10.5301/tj.5000224. Epub 2015 Feb 16.
BACKGROUND: Non-small cell lung cancer (NSCLC) is one of the leading causes of cancer mortality. MicroRNAs (miRNAs), small noncoding RNAs, regulate the expression of genes that play roles in human cancer via posttranscriptional inhibition.METHODS: To identify the potential miRNA biomarkers in NSCLC,
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Construction of novel xanthine biosensor by using polymeric mediator/MWCNT nanocomposite layer for fish freshness detection.

Dervisevic M1, Custiuc E1, Çevik E1, Şenel M2.
Food chemistry.Food Chem.2015 Aug 15;181:277-83. doi: 10.1016/j.foodchem.2015.02.104. Epub 2015 Feb 27.
A novel nanocomposite host matrix for enzyme immobilization of xanthine oxidase was developed by incorporating MWCNT in poly(GMA-co-VFc) copolymer film. In the food industry fish is a product with a very low commercial life, and a high variability as well elevated level of xanthine is an important b
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Principles and limitations of stable isotopes in differentiating organic and conventional foodstuffs: 1. Plant products.

Inácio CT1, Chalk PM, Magalhães AM.
Critical reviews in food science and nutrition.Crit Rev Food Sci Nutr.2015 Jul 29;55(9):1206-18. doi: 10.1080/10408398.2012.689380.
Among the lighter elements having two or more stable isotopes (H, C, N, O, S), δ(15)N appears to be the most promising isotopic marker to differentiate plant products from conventional and organic farms. Organic plant products vary within a range of δ(15)N values of +0.3 to +14.6%, while conventio
PMID 24915332

Japanese Journal

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岡﨑正晃,及川剛,菅谷健
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NAID 40020528304

筋炎および間質性肺炎のバイオマーカーとしての抗ARS抗体の検査について (特集抗アミノアシルtRNA合成酵素抗体と間質性肺炎 : 最近の話題)

三森経世
日本胸部臨床 74(7), 730-738, 2015-07
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Development of monoclonal antibodies against Plasmodium falciparum thioredoxin peroxidase 1 and its possible application for malaria diagnosis

Hakimi Hassan,Goto Yasuyuki,Suganuma Keisuke,Angeles Jose Ma M.,Kawai Satoru,Inoue Noboru,Kawazu Shin-ichiro
Experimental Parasitology 154, 62-66, 2015-07
… Altogether, these findings suggest that PfTPx-1 is a promising biomarker to diagnose P. …
NAID 120005611349

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