The Analytical Validation working group has collaborated to generate the Generic Analytical Validation Protocols for Cell-Free Assay Performance Verification v1.0, designed to provide test developers/manufacturers with a baseline of standardized protocols with which to document the analytical performance of a cell-free DNA assay. The generic protocols are intended for use by developers and manufacturers of blood-based liquid biopsy in vitro diagnostic tests for oncology, regulatory bodies and clinical laboratories. The protocols were formally reviewed by the FDA via the agency’s Pre-Submission process and published in the September 2020 issue of Clinical Chemistry. Establishing this vital industry standard will enable test developers to streamline their efforts to align with the FDA during their proposed product’s Pre-Submission phase and help minimize the time spent by FDA reviewers on guiding test developers through the process. As follow up deliverables, the working group is focusing on two additional protocol documents, including: