Daniel Hayes, MD
Despite the "extremely high level of current enthusiasm” for circulating tumor DNA (ctDNA) testing, there is very little evidence of clinical validity or clinical utility to justify the widespread use of ctDNA assays in most patients with advanced cancer, according to a panel of experts from the American Society of Clinical Oncology and the College of American Pathologists who reviewed studies representing over a decade of clinical research.1
The panel made an exception for assays that have demonstrated clinical utility or gained regulatory approval, but noted that the rapid uptake of ctDNA testing calls for “robust” research to clarify how ctDNA assays should be used and develop guidelines.
In addition, the panel found that “there is no evidence of clinical utility and little evidence of clinical validity of ctDNA assays in earlystage cancer, treatment monitoring, or residual disease detection,” and no evidence exists to support the use of ctDNA tests for cancer screening “outside of a clinical trial.”
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