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Advancing Precision Medicine: Harnessing Molecular Biomarkers for Oncology Clinical Trials

The following Insight is a featured article from WCG’s 2025 Trends & Insights Report. If you would like to read more insights from this report, please click here.


Precision medicine research relies on genetic and molecular data to identify eligible participants for a clinical trial, or to tailor the investigational treatment to the individual participant. This means that genetic and molecular markers may play a role both in subject recruitment/eligibility and in clinical endpoint determination, depending on protocol design.   

One expected trend in molecular biomarkers for oncology is the increasing use of a more diverse array of biological samples, such as blood, urine, or saliva, to gather more information about a person’s disease state. Tumors release biological information, in the form of free DNA, circulating tumor cells (CTCs), and as extracellular vesicles (EVs). CTCs are cancer cells that exit a tumor and enter circulation spontaneously or in response to therapeutic interventions. EVs are nanoscale particles that are naturally released by healthy cells and tumor cells and contain a broad range of bioactive compounds and genetic information. New forms of microfluidics technology are being deployed to efficiently capture these circulating tumor cells and EVs, and to distinguish and sort tumor-derived material for molecular analysis.  

Recent proof of concept studies show that information encoded by DNA and RNA found in EVs isolated from the blood of cancer patients can accurately reflect the genetic content of paired tumor biopsies from the same subjects. As modular and portable sample collection technologies are developed, we will see increasing opportunities for samples to be collected at home, allowing for less burdensome and less invasive procedures in recruitment and follow-up.  

These technologies will also enable gathering of more precise and more complete longitudinal information regarding subject response to investigational treatment over time. Robust longitudinal response data have the potential to greatly enhance the prognostic power of specific biomarkers and are likely to play a role in validation of biomarker endpoints in support of FDA approval via the accelerated pathway, for example. 


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