Criteria for Evaluating Multi-cancer Early Detection Tests

Abstract

Cell-free DNA (cfDNA)-based tests are currently being developed to detect multiple cancers at early stages, when treatment is more likely to be successful. Unlike existing cancer screening tests in the United States, which target only five cancers (colon, breast, cervical, lung and, on an individual basis, prostate) and have high cumulative false-positive rates, a cfDNA-based multi-cancer early detection (MCED) test could detect multiple cancers simultaneously with a very low and fixed false-positive rate using a single blood draw. This could lead to a more efficient cancer-screening paradigm with greater public health impact. Although MCED tests are being evaluated in several large clinical trials and may be available for clinical use in the near future, a standardized framework for evaluating their performance and safety is still lacking. We propose and explain the rationale for nine criteria to assess cfDNA-based MCED tests. We believe that these criteria will help clinicians and other healthcare professionals evaluate the benefits and risks associated with this potentially transformative technology in a rigorous and pragmatic way.