Posted on: October 24th, 2023

Biomarker discovery is the process of identifying specific biological markers (biomarkers) that are associated with particular physiological or pathological processes, disease conditions, or responses to treatments. 

Biomarkers include a wide range of things, including proteins, genes, metabolites, hormones, and other molecules that are measurable in biological samples (blood, urine, tissue, or saliva). The discovery of biomarkers is a crucial step in various fields, including medicine, clinical research, and diagnostics, and serves many important purposes.

What Biomarker Discovery Does

There are many examples of things biomarker discovery helps with. These things include helping doctors and researchers both identify and make recommendations for dealing with specific conditions.

Disease Diagnosis

Biomarkers can help in the early and accurate diagnosis of diseases. For example, specific proteins or genetic markers in blood can indicate the presence of certain cancers.

Disease Prognosis

Biomarkers can provide information about the likely course of a disease, its severity, and the potential response to treatment. This information can guide healthcare decisions.

Treatment Selection

Identifying biomarkers associated with drug response allows for the selection of the most effective treatment options for individual patients, a field known as personalized or precision medicine.

Monitoring Disease Progression

Biomarkers can be used to track the progression of diseases, such as the measurement of certain enzymes in heart disease patients to assess heart function.

Predictive Biomarkers

Some biomarkers can predict an individual’s susceptibility to a disease or adverse events. For example, certain genetic markers can indicate an increased risk of developing Alzheimer’s disease.

Pharmacodynamic Markers

Biomarkers can be used to monitor the effects of drugs on the body and ensure that the intended biological responses are occurring.

How Biomarker Discovery Works

The process of biomarker discovery typically involves a few steps that can differ from field to field.

Biomarker Hypothesis

Researchers formulate hypotheses about potential biomarkers based on existing knowledge, clinical observations, or data from previous studies.

Biomarker Screening

High-throughput technologies, such as genomics, proteomics, and metabolomics, are often employed to screen a large number of potential biomarkers in biological samples.

Data Analysis

The collected data is analyzed to identify statistically significant associations between specific biomarkers and the condition or process of interest.


Candidate biomarkers are further validated using independent datasets or additional experiments to confirm their reliability and relevance.

Clinical Testing

Promising biomarkers are evaluated in clinical studies involving patient populations to assess their diagnostic or prognostic value.

Regulatory Approval

If a biomarker proves to be clinically useful, it may undergo regulatory approval processes, such as those set forth by the FDA, before being used in clinical practice or diagnostics.

Clinical Implementation

Once validated and approved, biomarkers can be integrated into clinical practice for disease diagnosis, prognosis, or treatment decision-making.

Biomarker discovery is a constantly evolving field, driven by advances in technology and our increasing understanding of the molecular and genetic underpinnings of diseases. It holds great promise for improving disease diagnosis and treatment, as well as advancing our understanding of complex biological processes.

Research at Biofortis

Biofortis is dedicated to protecting consumer health throughout the world by delivering a wide range of testing and consultancy services to the food, supplement, and nutrition industries. Biofortis supports this mission in two ways—through clinical trials and sensory and consumer insights testing. We specialize in clinical research targeting foods, ingredients, and dietary supplements that affect body structures, function, and overall health. Contact us with any clinical trial or scientific consulting needs.

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