Biomarker

Circulating Tumor DNA

ctDNA — Circulating tumor DNA consists of short fragments of DNA released by tumor cells into the bloodstream. As a liquid biopsy analyte, ctDNA is associated with tumor burden and genomic alterations, making it one of the most actively investigated biomarkers in oncology research.

Overview

What is circulating tumor DNA?

Circulating tumor DNA (ctDNA) refers to fragments of DNA that are shed by tumor cells into the bloodstream through processes including apoptosis, necrosis, and active secretion. These fragments typically range from 120 to 200 base pairs in length and carry the same genetic mutations, methylation patterns, and structural alterations as the tumor from which they originate. Unlike a tissue biopsy, ctDNA can be obtained from a standard blood draw, enabling non-invasive access to a tumor's molecular profile.

The concentration of ctDNA in blood varies widely depending on tumor type, stage, and location. In advanced solid tumors, ctDNA may constitute a measurable fraction of total cell-free DNA (cfDNA), while in early-stage cancers, its fraction can be extremely low — sometimes below 0.01% of total cfDNA. This has driven significant advances in ultra-sensitive sequencing technologies and bioinformatic methods designed to detect tumor-derived fragments against a high background of normal cell-free DNA.

ctDNA is distinct from other circulating nucleic acids and should not be confused with total cell-free DNA, which includes DNA released from normal cells during routine tissue turnover. The tumor-specific mutations present in ctDNA are what distinguish it as a cancer-associated biomarker and underpin its utility in clinical and research settings.

Clinical Significance

Why ctDNA matters in clinical research.

Treatment response monitoring. Changes in ctDNA levels during therapy have been associated with treatment response across multiple cancer types. Declining ctDNA levels may correlate with tumor shrinkage, while rising levels may signal resistance or progression before imaging changes become apparent.

Minimal residual disease detection. Following curative-intent surgery, the presence or absence of ctDNA has been associated with recurrence risk. Studies in colorectal, breast, and lung cancers have shown that patients with detectable post-operative ctDNA face a substantially higher risk of recurrence compared to those without.

Genomic profiling without tissue biopsy. ctDNA analysis can reveal actionable mutations, enabling clinicians to identify targeted therapy options when tissue biopsy is not feasible. This is particularly relevant in cancers where tumor tissue is difficult to access, such as certain brain or pancreatic tumors.

Multi-cancer early detection research. ctDNA is a core analyte in emerging multi-cancer early detection (MCED) tests, where methylation patterns on cell-free DNA are analyzed to identify the tissue of origin and detect cancer signals across dozens of cancer types simultaneously.

Prevena's Approach

Investigating ctDNA through continuous molecular surveillance.

Prevena Health is investigating whether continuous biomarker surveillance may enhance the clinical utility of ctDNA analysis. Current approaches to ctDNA testing rely on single-point blood draws, which capture a snapshot of circulating DNA at one moment in time. Prevena's platform aims to support longitudinal monitoring that may reveal trends, rate-of-change patterns, and transient signal fluctuations that point-in-time measurements could miss.

By exploring continuous sampling through a skin-worn biosensor, Prevena is researching whether frequent ctDNA measurements could support earlier identification of molecular changes associated with tumor dynamics. This approach may complement existing diagnostic workflows and provide additional temporal context for clinicians and researchers working in oncology.

Prevena Health's platform is in development and is not commercially available. It has not been cleared, approved, or authorized by the U.S. Food and Drug Administration (FDA) or any other regulatory body. It is not a diagnostic device. Content on this page is for informational purposes only and does not constitute medical advice, diagnosis, or treatment.

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We are seeking clinical and research collaborators to advance continuous ctDNA surveillance as part of multi-cancer detection research.

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