Division of Imaging, Diagnostics, and Software Reliability, US Food and Drug Administration, Silver Spring, Maryland.
Citations 1
Development and evaluation of safety and effectiveness of novel cancer screening tests for routine clinical use with applications to multicancer detection technologies
Cancer | February 8, 2022 | Volume: 128 | Issue: S4 | Pages: 883-891
Multicancer screening is a promising approach to improving the detection of preclinical disease, but current technologies have limited ability to identify precursor or early stage lesions, and approaches for developing the evidentiary chain are unclear. Frameworks to enable development and evaluation from discovery through evidence of clinical effectiveness are discussed.