Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases

Phillip G Febbo¹, Anne-Marie Martin², Howard I Scher³, J Carl Barrett⁴, Julia A Beaver⁵, Paul J Beresford⁶, Gideon M Blumenthal⁴, Kelli Bramlett⁷, Carolyn Compton⁸, Ryan Dittamore⁹, David A Eberhard¹, Daniel Edelstein¹⁰, James Godsey¹, Andrew Gruen¹¹, Sean E Hanlon¹², James Hicks¹³, Daniel Hovelson¹⁴, Melanie Hullings³, Donald Johann¹⁵, Justin Johnson⁴, Anand Kolatkar¹³, Peter Kuhn¹³, Rebecca Levine¹⁶, Jean-Francois Martini¹⁷, Daniel P Miller¹⁸, Carissa Moore¹⁹, Bryan Moy¹¹, Anand Pathak²⁰, Reena Philip²⁰, David Reese²¹, Wendy Royalty¹⁹, Matthew Ryder¹⁰, Hakan Sakul¹⁷, Lea M Salvatore²², Andrew Schade²³, Angela Silvestro²⁴, John K Simmons²⁵, Jonathan Simons¹⁶, Seema Singh Bhan²⁶, Matthew D Smalley²⁷, Stella B Somiari²⁸, AmirAli Talasaz²⁹, Muneesh Tewari¹⁴, Hsian-Rong Tseng²⁷, Jake Vinson³⁰, Walt Wells²², Allison Welsh²⁶, Robert L Grossman¹⁸, Jerry S H Lee¹³, Lauren C Leiman³¹

Affiliations

¹ Illumina, San Diego, California, USA.
² Novartis Pharmaceuticals, East Hanover, New Jersey, USA.
³ Memorial Sloan Kettering Cancer Center, New York, New York, USA.
⁴ AstraZeneca, Waltham, Massachusetts, USA.
⁵ Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Springs, Maryland, USA.
⁶ Biodesix, Inc, Boulder, Colorado, USA.
⁷ Thermo Fisher Scientific, Austin, Texas, USA.
⁸ College of American Pathologists, Scottsdale, Arizona, USA.
⁹ Epic Sciences, San Diego, California, USA.
¹⁰ Sysmex Inostics, Baltimore, Maryland, USA.
¹¹ Seven Bridges Genomics, Boston, Massachusetts, USA.
¹² Office of the Director, National Cancer Institute, Bethesda, Maryland, USA.
¹³ University of Southern California, Los Angeles, California, USA.
¹⁴ University of Michigan, Ann Arbor, Michigan, USA.
¹⁵ University of Arkansas, Little Rock, Arkansas, USA.
¹⁶ Prostate Cancer Foundation, Los Angeles, California, USA.
¹⁷ Pfizer, San Diego, California, USA.
¹⁸ Center for Translational Data Science, University of Chicago, Chicago, Illinois, USA.
¹⁹ Streck, Inc., La Vista, Nebraska, USA.
²⁰ Center for Device and Radiological Health, US Food and Drug Administration, Silver Springs, Maryland, USA.
²¹ Provista Diagnostics Inc, New York, New York, USA.
²² Open Commons Consortium, Chicago, Illinois, USA.
²³ Eli Lilly and Company, Indianapolis, Indiana, USA.
²⁴ Novartis Pharmaceuticals, Cambridge, Massachusetts, USA.
²⁵ Personal Genome Diagnostics, Baltimore, Maryland, USA.
²⁶ Foundation Medicine, Cambridge, Massachusetts, USA.
²⁷ CytoLumina, Inc, Los Angeles, California, USA.
²⁸ CSSIMMW (Windber Research Institute), Windber, Pennsylvania, USA.
²⁹ Guardant Health, Inc, Redwood City, California, USA.
³⁰ Prostate Cancer Clinical Trials Consortium, New York, New York, USA.
³¹ BloodPAC, Chicago, Illinois, USA.

PMID: 32017048
PMCID: PMC7158216
DOI: 10.1002/cpt.1747

Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases

Phillip G Febbo et al. Clin Pharmacol Ther. 2020 Apr.

. 2020 Apr;107(4):730-734.

doi: 10.1002/cpt.1747. Epub 2020 Feb 4.

Authors

Affiliations

¹ Illumina, San Diego, California, USA.
² Novartis Pharmaceuticals, East Hanover, New Jersey, USA.
³ Memorial Sloan Kettering Cancer Center, New York, New York, USA.
⁴ AstraZeneca, Waltham, Massachusetts, USA.
⁵ Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Springs, Maryland, USA.
⁶ Biodesix, Inc, Boulder, Colorado, USA.
⁷ Thermo Fisher Scientific, Austin, Texas, USA.
⁸ College of American Pathologists, Scottsdale, Arizona, USA.
⁹ Epic Sciences, San Diego, California, USA.
¹⁰ Sysmex Inostics, Baltimore, Maryland, USA.
¹¹ Seven Bridges Genomics, Boston, Massachusetts, USA.
¹² Office of the Director, National Cancer Institute, Bethesda, Maryland, USA.
¹³ University of Southern California, Los Angeles, California, USA.
¹⁴ University of Michigan, Ann Arbor, Michigan, USA.
¹⁵ University of Arkansas, Little Rock, Arkansas, USA.
¹⁶ Prostate Cancer Foundation, Los Angeles, California, USA.
¹⁷ Pfizer, San Diego, California, USA.
¹⁸ Center for Translational Data Science, University of Chicago, Chicago, Illinois, USA.
¹⁹ Streck, Inc., La Vista, Nebraska, USA.
²⁰ Center for Device and Radiological Health, US Food and Drug Administration, Silver Springs, Maryland, USA.
²¹ Provista Diagnostics Inc, New York, New York, USA.
²² Open Commons Consortium, Chicago, Illinois, USA.
²³ Eli Lilly and Company, Indianapolis, Indiana, USA.
²⁴ Novartis Pharmaceuticals, Cambridge, Massachusetts, USA.
²⁵ Personal Genome Diagnostics, Baltimore, Maryland, USA.
²⁶ Foundation Medicine, Cambridge, Massachusetts, USA.
²⁷ CytoLumina, Inc, Los Angeles, California, USA.
²⁸ CSSIMMW (Windber Research Institute), Windber, Pennsylvania, USA.
²⁹ Guardant Health, Inc, Redwood City, California, USA.
³⁰ Prostate Cancer Clinical Trials Consortium, New York, New York, USA.
³¹ BloodPAC, Chicago, Illinois, USA.

PMID: 32017048
PMCID: PMC7158216
DOI: 10.1002/cpt.1747

No abstract available

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Conflict of interest statement

The work described here was done through the BloodPAC Consortium, which is a not‐for‐profit consortium consisting of members from industry, academia, not‐for‐profits, and US government agencies, including companies that sell liquid biopsy assays, companies that use liquid biopsy assays as companion diagnostics, organizations that do research related to liquid biopsies, organizations that conduct clinical trials involving liquid biopsies, and agencies that develop policies and procedures related to liquid biopsies. In addition, some of the authors are employed by companies in the liquid biopsy field, employed by companies that have projects and partnerships with liquid biopsy companies, have stock in companies in the liquid biopsy field, or consult with companies in the liquid biopsy field. The authors worked together collaboratively to develop consensus recommendations on data elements for the liquid biopsy field as a whole and the authors do not have any particular or specific conflict with the work described in this paper, beyond those just enumerated.

Figures

**Figure 1**
A graphical workflow view of the 11 Minimum Technical Data Elements (MTDEs).

See this image and copyright information in PMC

References

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Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases

Affiliations

Minimum Technical Data Elements for Liquid Biopsy Data Submitted to Public Databases

Authors

Affiliations

Conflict of interest statement

Figures

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources