Thursday, October 6

Do Not Overlook These Warning Signs While Conducting Biomarker Assay Development And Validation

Biomarkers are used increasingly at every stage of drug discovery and development. Applications such as multiplex biomarker assays and cytokine testing have made biomarkers popular among scientists and researchers. However, there is a lack of clarity when it comes to biomarker development and validation. Regulatory requirements for PK assay are well covered by regulatory guidance. But there is often confusion about biomarker assays. Hence, biomarker assay requires a fresh perspective on how to develop, establish and validate assay criteria. Thus, the current article provides critical warning signs that researchers must not overlook while conducting biomarker development and validation.

Challenges and warning signs in biomarker assay development and validation

Each biomarker assay platform is unique. Hence, different biomarker studies will have distinct warning signs and challenges. Let us understand each of these challenges individually.

Scientific challenges

A robust biomarker assay will require a complete understanding of the underlying biological and physiological processes. Hence, the target population, biological mechanism, endogenous form of the analytes, anticipated biomarker levels, turnover rate, biological variability, and the effect a biomarker will have on the generated data are some considerations biomarker validation services must evaluate while developing and validating biomarker assays. Besides, due to its ever-evolving nature, some aspects of a biomarker assay may not remain consistent throughout the drug discovery and drug development phase. Hence, biomarker services must reevaluate the context of use as new drug data emerge, such as new indications and genotypes.

Analytical platform

Today scientists have numerous analytical approaches at their disposal. Each platform will have its advantages and limitations. A biomarker can be soluble, a downstream event, a direct marker of engagement, surface protein, or present at a genetic level. One analytical platform may be suitable for one biomarker, while another may be for a different purpose. Besides, assay precision may depend on analytical variability and the assay platform used for analysis. Hence, scientists must consider these challenges in biomarker validation studies.


Communication is the key to a successful biomarker assay development and validation. For companies having a large team of employees present at different layers of the organization, the discussion process can take a setback. Hence, it is necessary to identify relevant stakeholders and incorporate them in study discussions. Moreover, it becomes more crucial in a sponsor-CRO relationship, where decisions are purely made based on cost and time instead of relying on discussions. Scientists must ensure that they understand how the data is collected, where it will be used, the decisions that will be affected, proposed biomarker use, study design, and associated risks, and accordingly communicate them with relevant stakeholders.

Regulatory expectations

The regulatory bodies are familiar with PK analysis. Hence, any deviation from this process can be challenging for the sponsors. Exploratory, primary, and secondary clinical endpoints do not adequately describe assay development and validation. However, they are used commonly in regulatory compliance. Besides, regulatory bodies are still in the learning phase when it comes to multiplex biomarkers and biomarker assays in general,. Hence, if study designs and results are not adequately defined, regulatory bodies may develop a negative opinion about the developed biomarker assay.

Leave a Reply

Your email address will not be published.