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| title | chunk | source | category | tags | date_saved | instance |
|---|---|---|---|---|---|---|
| Biomarker | 2/3 | https://en.wikipedia.org/wiki/Biomarker | reference | science, encyclopedia | 2026-05-05T07:15:13.536230+00:00 | kb-cron |
== Research == Biomarkers for precision medicine are a part of a relatively new behavioral and clinical toolset. In terms of the behavioral toolset, biomarkers are increasingly being used to motivate health behavior change, particularly in diabetes, cardiovascular diseases, and obesity research. Most research to date uses biomarkers that are easily measured, including weight, blood pressure, and glucose; these biomarkers may reflect the impacts of diet, physical activity, and smoking reduction. However, the methods by which feedback from biomarkers are used in intervention research are varied, and their effectiveness remains unclear. In reference to the clinical toolset, only two predictive biomarkers are implemented clinically in the case of metastatic colorectal cancer. In this case, the lack of data beyond retrospective studies and successful biomarker-driven approaches may be a factor in using biomarker studies due to the attrition of subjects in clinical trials. The field of biomarker research is also expanding to include a combinatorial approach to identifying biomarkers from multiple sources. Combining biomarkers from various data allows for the possibility of developing panels that evaluate treatment response based on many biomarkers at a single time. One such area of expanding research in multiple-factor biomarkers is mitochondrial DNA sequencing. Mutations in mitochondrial DNA have been shown to correlate to risk, progression, and treatment response of head and neck squamous cell carcinoma. In this example, a relatively low cost sequencing pipeline was shown to be able to detect low frequency mutations within tumor-associated cells. This highlights the general snapshot capability of mitochondrial DNA-based biomarkers in capturing heterogeneity amongst individuals.
== Regulatory validation for clinical use == The Early Detection Research Network (EDRN) compiled a list of seven criteria by which biomarkers can be assessed in order to streamline clinical validation.
=== 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. The biologic rationale of a study must be assessed on a small scale before any large scale studies can occur. Many candidates must be tested to select the most relevant ones.
=== 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 parallelism reproducibility practicality ethicality
=== 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.
== Ethical issues == In 1997 the National Institute of Health suggested a need for guidelines and legislation development that would regulate the ethical dimensions of biomarker studies. Ensuring that all of the participants that are included each step of the project (i.e. planning, implementation, and the compilation of the results) are provided with the protection of ethical principles that are put in place prior to beginning the project. These ethical protections should not only protect the participants in the study, but also the non participants, researchers, sponsors, regulators, and all other persons or groups involved in the study. Some ethical protections could include but are not limited to:
Informed consent of the participant Access to participation opportunities independent of race, socio-economic status, gender, sexuality, etc. (within the range allowed by the experimental protocol) Scientific integrity Confidentiality of data (anonymity) Acknowledgement of conflict of interest in terms of funding and sponsorship by given sponsors Transparency and recognition of health and legal risks involved in participation
== 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). 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.
== Applications in chemistry, 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. Biomarkers were used in the geo-chemical investigation of an oil spill in the San Francisco Bay, California in 1988. On April 22–23 around 400,000 gallons of crude oil was accidentally released into the San Joaquin Valley by a refinery and manufacturing complex of the Shell Oil Company. The oil affected many surrounding areas. Samples of the crude oil were collected in the various regions where it had spread and compared to samples that were unreleased in an attempt to distinguish between the spilled oil and the petrogenic background present in the spill area. Mass Spectra was performed to identify biomarkers and cyclic aliphatic hydrocarbons within the samples. Variations in the concentration of constituents of the crude oil samples and sediments were found.
== Ecotoxicology ==