Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases
The journal Clinical Pharmacology & Therapeutics has published a paper developed by BloodPAC, “Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases.” The publication captures a list of 11 Pre-analytical Minimal Technical Data Elements (MTDEs), attributes suggested for collection and submission to ensure data submitted to the BloodPAC Data Commons (BPDC) can be accurately evaluated and analyzed across BloodPAC participants and members of the broader liquid biopsy community.
BloodPAC undertook the task of identifying and selecting the preanalytical variables most commonly associated with cell‐free DNA (cfDNA) test design and development to help standardize the data fields innovators should incorporate into their work. The 11 MTDEs defined by BloodPAC reflect a range of factors that influence the performance of the assay itself in the laboratory that may affect final assay result. These include defining the factors that may affect the limit of detection and the variables required to ensure reproducibility/repeatability for each phase or aspect of test development. BloodPAC defined MTDEs starting from 52 data elements, based on input from industry, academia, not‐for‐profits and the U.S. Food and Drug Administration.
The publication of MTDEs advances BloodPAC’s mission to optimize patient care, by creating industry-wide standards for quality and rigor used across the continuum of test development, from preanalytical variables, analytical variables and clinical validation.
