What is a biomarker and what is biomarker analysis?

• Biomarkers Defined: Biomarkers are measurable indicators of biological processes, pathogenic processes, or responses to therapeutic interventions. They vary depending on their application, from physiological measurements to gene expression.
• Qualification and Importance: For regulatory acceptance, biomarkers must be qualified through extensive clinical and pharmaceutical collaboration. Established biomarkers like hormones are widely used, while new biomarkers are crucial in advancing disease understanding, diagnosis, and treatment.
• Biomarker Analysis: This involves the validation of methods used to quantify biomarkers. The level of validation depends on whether the biomarker is exploratory or established, influencing the choice of analytical approaches.
• Real-World Applications: Biomarker research has led to targeted treatments, such as in lung cancer, and is advancing understanding in neurodegenerative and mental health diseases.
• Broader Impact: The discovery and analysis of biomarkers are vital for early disease diagnosis and effective treatment, underscoring their growing importance in medical and pharmaceutical research.

Biomarker is a term used in medicine, physiology, clinical analysis, pharmaceutical development, and clinical diagnostics. In this post, we will examine biomarkers and what we mean when discussing biomarker analysis.

What is a Biomarker?

So, ‘what is a biomarker?‘ According to the FDA / NIH working group, a biomarker is ‘a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.’

This means that biomarkers can differ depending on the application. So, blood pressure and lung function are classified as biomarkers for physiological measurements. In the clinical laboratory, liver function tests and physiological electrolyte levels are examples of biomarkers. In biopharmaceutical development, cytokines, growth factors, neurological peptides, and gene expression are biomarkers or potential biomarkers.

To be recognized as a biomarker by regulatory agencies, biomarkers must be ‘qualified’. This is an activity that is determined by the substantial clinical and pharmaceutical collaboration to confirm and demonstrate the role of the biomarker and that it fulfils the criteria above.

Importance of Biomarkers

Many biomarkers, such as hormones and inflammatory mediators, have been well-established for decades, and methods for measuring them are routine within the clinical setting. Medical and pharmaceutical research is constantly evolving and deepening the understanding of many disease pathologies that have thus far eluded full definition. The identification of ‘new’ biomarkers greatly assists these endeavours and, importantly, the ability to quantify these biomarkers at meaningful levels that eventually can be used predictively, diagnostically, and prognostically in relation to disease.

What is Biomarker Analysis?

As can be seen above, much effort is required in drug discovery and clinical development, with the accompanying analysis of a multitude of potential biomarkers and confirmation of their usefulness as part of the process. The intended use of the data from such analyses is important in determining the level of assay development and validation required. It is worth noting the distinction between biomarker qualification and qualification/validation of biomarker analysis. Biomarker qualification is described above.

For biomarker analysis validation, this refers to the methods used to quantify the biomarkers. A full, comprehensive development and validation of a method for every exploratory biomarker would be impractical. It is important, therefore, to determine what is referred to as the ‘context of use’.

Context of Use in Biomarker Analysis

In short, if the analysis aims to be fact-finding and purely exploratory, an off-the-shelf kit may be used without in-depth validation. For exploratory biomarkers, a multiplex approach is a popular choice, where basic information can be derived on anything between 2 to 30 analytes at the same time in a cost and time-effective manner. If, however, the biomarker is established or intended to be used in decision-making steps in the progress of a clinical study, a full validation would be expected.

There are a number of diverse analytical approaches that can be taken, including immunoassay, flow cytometry, and LC-MS/MS, to name but a few.

Real-World Applications and Importance

Such is the importance of biomarker research. A topical example of the utility of biomarkers made it to mainstream US news just last month, where the identification of a specific biomarker enabled lifesaving treatment for a young lung cancer patient due to the ability to treat the disease in a targeted manner.

In recent years, attention to neurodegenerative diseases such as Alzheimer’s and Parkinson’s disease has accelerated due to the increasing prevalence and previously intractable nature of these diseases. Although cures are still some way away, advances have been made in no small measure due to the identification of specific biomarkers.

Another identified plight of the modern age is the impact of mental health diseases, and within this field, potential biomarkers are under investigation.

In the broader outlook, the discovery of biomarkers and ascertaining their role in pathological conditions cannot be overestimated. Medical, technical, and analytical advances are impressive and increasingly useful in the diagnosis of diseases in their early stages and subsequent treatment.

If you’re interested in learning more about biomarkers and their role in clinical diagnostics, or if you need expert assistance with biomarker analysis in your research or clinical trials, contact our team today. We offer comprehensive services and support to help you navigate the complexities of biomarker research and validation. Get in touch to explore how we can support your projects.