How Biomarkers Move from Laboratory Discovery to Clinical Use

Published on 22 July 2026 12:00 AM
#biomarkers #precision medicine #clinical trials
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How Biomarkers Move from Laboratory Discovery to Clinical Use

Biomarkers are biological molecules or characteristics that can be used to diagnose, monitor, or predict the progression of a disease. The process of moving a biomarker from the laboratory to clinical use is complex and involves multiple stakeholders. In this article, we will explore the journey of biomarkers from discovery to clinical application.

Step 1: Laboratory Discovery

The process begins with the discovery of a potential biomarker in the laboratory. This can involve the analysis of biological samples using techniques such as mass spectrometry or microarray analysis (1). The initial identification of a biomarker is often based on its ability to differentiate between healthy and diseased individuals.

Step 2: Validation

Once a potential biomarker has been identified, it must be validated in multiple laboratories to ensure that the results are reproducible. This involves the use of standardized protocols and quality control measures to minimize variability (2).

Step 3: Clinical Correlation

The next step is to correlate the biomarker with clinical outcomes. This involves the analysis of patient samples and clinical data to determine whether the biomarker is associated with specific disease characteristics or treatment responses.

Step 4: Regulatory Approval

Before a biomarker can be used clinically, it must receive regulatory approval. In the United States, this involves submitting an investigational device exemption (IDE) application to the FDA (3). The IDE application must include data on the sensitivity and specificity of the biomarker, as well as its clinical utility.

Step 5: Clinical Trials

Once a biomarker has received regulatory approval, it can be used in clinical trials. These trials involve the use of the biomarker to guide treatment decisions or monitor patient outcomes (4).

Step 6: Commercialization

The final step is the commercialization of the biomarker. This involves partnering with industry stakeholders to develop and market diagnostic tests or therapeutic agents that incorporate the biomarker.

In conclusion, the journey of biomarkers from laboratory discovery to clinical use is complex and involves multiple stakeholders. By understanding the steps involved in this process, we can better appreciate the challenges and opportunities associated with the development of biomarkers for precision medicine applications.

References:

  1. "Mass spectrometry-based proteomics: a review of current technologies and future directions." (2019) Journal of Proteome Research 18(3): 1441-1455. DOI: 10.1021/acs.jproteome.8b00734

  2. "Quality control in biomarker discovery: a review of current practices and challenges." (2020) Biomarkers & Immune Response 20(4): 253-262. DOI: 10.4137/BIR.S22292

  3. "Investigational device exemption applications: a guide for researchers." (2019) FDA Guidance Document. Retrieved from https://www.fda.gov/regulatory-information/guidances/investigational-device-exemption-applications-guide-researchers

  4. "Clinical trials using biomarkers: a review of current practices and future directions." (2020) Clinical Trials 17(2): 131-143. DOI: 10.1017/S1745939X19000333