Precision medicine would not be possible without biological markers, or biomarkers. Medical practitioners need molecular information coupled with phenotypic health data to deliver truly targeted therapies to patients. This is predicated on the availability of biomarker solutions which enable high-sensitivity detection methods for diagnoses, and targeted drug delivery for novel treatment. Yet the development of high-quality biomarkers has been a slow process fraught with high failure rates.
This article will explore how important accessing high-quality biomarkers and the accompanying health data is to cutting-edge healthcare approaches. Plus, we will outline how to develop a biomarker strategy of your own.
What are Biomarkers?
There are two main definitions of biomarkers. Hulka and colleagues defined them simply as “cellular, biochemical or molecular alterations that are measurable in biological media such as human tissues, cells, or fluids.” However, this has been expanded so that biomarkers can now be defined as measurable characteristics used as indicators of biological processes, whether normal, pathogenic, or following exposure to some therapeutic intervention.
Hence biomarker solutions now encompass a range of technologies, from the modern diagnostic tools which make underlying biological traits accessible, to the analytical systems that underpin precision care.
Different Types of Biomarkers
Some sources suggest that biomarkers can be delineated as either biomarkers of exposure or biomarkers of disease. Yet identifying different types of biomarkers is not such a simple task. The National Institutes of Health BEST (Biomarkers, EndpointS, and other Tools) Resource suggests that biomarkers may be named after a specific analyte, anatomic feature, biological source, or measurable physiological characteristic. Unique identifies are used, as are acronyms, which further complicates the matter. Fortunately, biomarker development has accelerated and improved while clinical assessments have begun to harmonize, addressing the issue of interpreting different types of biomarkers.
Biomarkers can broadly be outlined as molecular, histologic, physiologic or in some cases radiographic characteristics. These categories can be further subdivided into the following categories:
- Diagnostic biomarkers are used to detect the presence of a condition or to identify a subtype of the disease in patients.
- Monitoring biomarkers are used to continually assess the status of a condition, offering insight into the stages of the disease or the effectiveness of an intervention.
- Response biomarkers are used to demonstrate that a response, beneficial or otherwise, has occurred in response to an intervention.
- Predictive biomarkers are used to determine a patient’s likely responsiveness to a given treatment.
- Prognostic biomarkers are used to determine the likelihood of further clinical events, such as disease progression.
- Safety biomarkers are vital for eliminating toxicity risks and adverse side effects associated with exposure to a given treatment.
- Risk biomarkers help identify individuals who are at risk of developing a disease.
The scope of biomarker solutions is, therefore, incredibly vast, offering limitless opportunities for clinical trials, drug development, epidemiological studies, and so on.
How to Develop a Biomarker Strategy
Developing robust biomarker strategies often requires collaboration. At Synexa Life Sciences, we have years of experience designing biomarker solutions for clients across the full spectrum of drug development and healthcare. We can help you select the right markers with care, maximising the chances of successful outcomes.
Our scientists are well-versed in the needs of industry professionals and are dedicated to finding the best strategies for biomarker detection, analysis, and data interpretation. This includes optimising for costs, timelines, and other critical business metrics.
Interested in learning more about our specialised biomarker solutions? Contact a member of the Synexa team today.
References and further reading:
- Matzke LA, Watson PH. Biobanking for Cancer Biomarker Research: Issues and Solutions. Biomarker Insights. January 2020. doi:10.1177/1177271920965522
- Mayeux R. Biomarkers: potential uses and limitations. NeuroRx. 2004 Apr;1(2):182-8. doi: 10.1602/neurorx.1.2.182. PMID: 15717018; PMCID: PMC534923.
- US Food and Drug Administration, National Institutes of Health. BEST (Biomarkers, EndpointS, and other Tools) Resource. Bethesda, MD: National Institutes of Health; 2018.