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03/15/2023

Contrived Materials and a Data Set for the Evaluation of Liquid Biopsy Tests: A Blood Profiling Atlas in Cancer (BLOODPAC) Community Study

The Journal of Molecular Diagnostics Manuscript
Authors Kyle M. Hernandez, Kelli S. Bramlett, Phaedra Agius, Jonathan Baden, Ru Cao, Omoshile Clement, Adam S. Corner, Jonathan Craft, Dennis A. Dean II, Jonathan R. Dry, Kristina Grigaityte, Robert L. Grossman, James Hicks, Nikki Higa, Timothy R. Holzer, Jeffrey Jensen, Donald J. Johann, Sigrid Katz, Anand Kolatkar, Jennifer L. Keynton, Jerry S.H. Lee, Dianna Maar, Jean-Francois Martini, Christopher G. Meyer, Peter C. Roberts, Matt Ryder, Lea Salvatore, Jeoffrey J. Schageman, Stella Somiari, Daniel Stetson, Mark Stern, Liya Xu, Lauren C. Leiman

The Blood Profiling Atlas in Cancer (BLOODPAC) Consortium is a collaborative effort involving stakeholders from the public, industry, academia, and regulatory agencies focused on developing shared best practices on liquid biopsy. This report describes the results from the JFDI (Just Freaking Do It) study, a BLOODPAC initiative to develop standards on the use of contrived materials mimicking cell-free circulating tumor DNA, to comparatively evaluate clinical laboratory testing procedures. Nine independent laboratories tested the concordance, sensitivity, and specificity of commercially available contrived materials with known variant-allele frequencies (VAFs) ranging from 0.1% to 5.0%. Each participating laboratory utilized its own proprietary evaluation procedures. The results demonstrated high levels of concordance and sensitivity at VAFs of >0.1%, but reduced concordance and sensitivity at a VAF of 0.1%; these findings were similar to those from previous studies, suggesting that commercially available contrived materials can support the evaluation of testing procedures across multiple technologies. Such materials may enable more objective comparisons of results on materials formulated in-house at each center in multicenter trials. A unique goal of the collaborative effort was to develop a data resource, the BLOODPAC Data Commons, now available to the liquid-biopsy community for further study. This resource can be used to support independent evaluations of results, data extension through data integration and new studies, and retrospective evaluation of data collection.

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