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Limited Evidence for Clinical Validity, Utility of ctDNA

No evidence for circulating tumor DNA assays in early-stage cancer, residual disease detection

MONDAY, March 5, 2018 (HealthDay News) — There is little evidence for the clinical validity or utility of circulating tumor DNA (ctDNA) assays for solid tumors, according to a special article published online March 5 in the Journal of Clinical Oncology.

Jason D. Merker, M.D., Ph.D., from the Stanford University School of Medicine in California, and colleagues conducted a literature review on the use of ctDNA assays for solid tumors. Seventy-seven articles were selected for inclusion in the review.

The researchers found that the clinical validity and utility for some ctDNA assays was demonstrated with certain types of advanced cancer; however, for the majority of ctDNA assays there was insufficient evidence of clinical validity and utility in advanced cancer. There was discordance between the results of ctDNA assays and genotyping tumor specimens; evidence supported tumor tissue genotyping to confirm undetected results from ctDNA tests. In early-stage cancer, treatment monitoring, or residual disease detection, there was no evidence for clinical utility and little evidence of clinical validity for ctDNA assays.

“There is no evidence of clinical validity and clinical utility to suggest that ctDNA assays are useful for cancer screening, outside of a clinical trial,” the authors write. “Given the rapid pace of research, re-evaluation of the literature will shortly be required, along with the development of tools and guidance for clinical practice.”

Several authors disclosed financial ties to the pharmaceutical industry; several authors are named on patents related to the research.

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