What Are the Various Applications of Biomarkers?
Biomarkers are used in various applications related to these three main areas:
They help to assign a certain amount of predictability for certain illnesses.
They can help to identify precursors for advanced diseases such as cancers or blood disorders.
They play a major role in the drug discovery and development process
Clinical thought leaders actively engage the idea that biomarkers are the centerpiece for finding revolutionary discoveries in medicine and in pharmacologic endeavors. (1) Biomarkers are a crucial element to a majority of scientific research and medically necessary to determine the potentiality of disease and exposure. (2) As an integral component of the clinical trial process, biomarkers serve as a method to determine the efficacy or effect of many medical-related procedures and circumstances. Additionally, biomarkers are one of the valued measurements for the effects of toxic exposure. (3)
Biomarkers Are Essential to the Drug Discovery and Development Process
Biomarkers studies require the processing and storage of numerous biospecimen samples for the purpose of storing information and reducing research expenses. Biorepositories maintain the characterized samples and usher them to specified research purposes and clinical applications. Biomarkers are multi-dimensional in terms of usage. The chief function that they offer a set of directional cues for researchers. The big scientific shift into genomics, bioinformatics, cytometry, and other related modalities is helping to find specific biomarkers that are associated with solving the riddles related to chronic disease. (4) (5)
Biomarker Classifications
Exploratory Biomarkers - Tools used at the preclinical phase without evidence necessarily linking the biomarker to a designated clinical outcome in humans.
Demonstration Biomarkers - This means the biomarker has been qualified (not validated) in terms of preclinical sensitivity and is linked with specific clinical or patient outcomes, but without having to be reproduced in the context of a clinical study.
Characterization Biomarkers - demonstrates adequate preclinical sensitivity and specificity and are able to link to clinical outcomes. The progression of qualification leads to increased use of a biomarker in decision making regulatory applications.
Validating biomarkers
Some of the biggest challenges are to validate and characterize large quantities of bio-tissue samples to meet the demand. (6)This is where strategic partnerships with biorepositories such as Geneticist comes into full view. We process and house large quantities of biospecimens that are viable enough to move forward to the clinical trial process. The scientific community had some concerns about the slow progress of biomarker research due to low standards in specimen collection and handling paired with overall poor trial design. (7)
Biorepositories and Biomarker Processing
Geneticist is the gold standard when it comes to the logistics and technical complexities of biomarker validations. “Omic” platforms I.e. genomics, proteomics, etc., rely upon the ability to put into play large quantities of analytes in single customized assays – we provide this support to our research partners. We can prepare validated assays needed to facilitate the rapid generation of data needed to qualify the biomarker for reuse in another purpose. (6) (9)
Understanding the Differences Between Biomarkers and Clinical Endpoints
When trying to find the distinguishing aspects between biomarkers versus a clinical endpoint, we only need to evaluate their chief point of function to find the difference. The major function of a biomarker is to find a point of observation that best represents the existing clinical circumstance. Conversely, the major function of a clinical endpoint is to identify an outcome. (10) It can be a primary or secondary notation, and it most often addresses an answer to a research question.
Biomarkers act as an objective or observed point of reference to identifying a quantifiable measurement. They do not take into consideration the patient’s perspective. (6)
Clinical Endpoints represent a clinical outcome measured by a clinical trial and include a first-persons point of view or perspective. It answers questions: How did the patient feel? How did the patient function? Did the patient survive? For example, survival is considered to be the most optimal clinical endpoint of HIV related studies. (12)
Example:
Patient-reported fever. Has elevated WBC.
Will Tylenol resolve the fever? Tylenol was given at 3 pm.
Endpoint answer: Fever ended at 5 pm. The patient feels better. The cessation of symptoms ended after 3 hours. (An endpoint serves as an answer to whether or not the Tylenol resolved the fever.)
Biomarkers: Elevated white blood cell count paired with fever is a biomarker thus implying an infection within the body.
The Future of Biomarkers
Trending, is the application of exosomes in use in various clinical capacities. Exosomes are extracellular vesicles first described as much as 30 years ago in regards to cell-communication and disease transmission. They are considered by many to be one of the most valuable biomarkers because they contain a footprint for cell mechanism of action. It is speculated that Exosomes will be best used as a diagnostic and prognostic tool for malignant tumors. Biorepositories can safely store exosomes for decades, as they tend to maintain their viability if stored under the proper conditions. (11) (12)
References and Further Reading
1. [Online] https://patientdaily.com/stories/510644132-medical-thought-leaders-call-for-action-on-biomarkers.
2. [Online] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC534923/.
3. [Online] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC534923/.
4. [Online] https://www.sciencedirect.com/science/article/pii/S0041008X05000864.
5. [Online] https://www.ncbi.nlm.nih.gov/pubmed/22523699.
6. [Online] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6037391/.
7. [Online] https://www.cell.com/trends/molecular-medicine/pdf/S1471-4914(12)00177-3.pdf.
8. [Online] https://www.europeanpharmaceuticalreview.com/article/4357/biomarkers-drug-discovery-development/.
9. [Online] https://www.cell.com/trends/molecular-medicine/pdf/S1471-4914(12)00177-3.pdf.
10. [Online] https://www.focr.org/clinical-trial-endpoints.
11. [Online] http://www.proofcentre.ca/resources/biomarker-solutions/what-are-biomarkers/.
12. [Online] https://www.focr.org/clinical-trial-endpoints.
13. [Online] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5502131/.
14. [Online] https://bmcbiol.biomedcentral.com/articles/10.1186/s12915-016-0268-z.