Paoletti, Costanza http://orcid.org/0000-0003-0162-2453
Regan, Meredith M.
Niman, Samuel M.
Dolce, Emily M.
Darga, Elizabeth P. http://orcid.org/0000-0001-7728-9162
Liu, Minetta C. http://orcid.org/0000-0002-8206-5232
Marcom, P. Kelly
Hart, Lowell L.
Smith, John W. II
Tedesco, Karen L.
Amir, Eitan http://orcid.org/0000-0002-3706-525X
Krop, Ian E. http://orcid.org/0000-0002-6380-5944
DeMichele, Angela M. http://orcid.org/0000-0003-1297-4251
Goodwin, Pamela J.
Block, Margaret
Aung, Kimberly
Brown, Martha E.
McCormack, Robert T.
Hayes, Daniel F.
Funding for this research was provided by:
Menarini Silicon Biosystems, Inc.
Janssen Diagnostics, LLC
Article History
Received: 14 January 2021
Accepted: 12 May 2021
First Online: 11 June 2021
Competing interests
: The authors declare the following competing interests: C.P. received travel reimbursement and research funding from Menarini Silicon Biosystems, Inc. (MSB) during the conduct of the study; research funding from AstraZeneca, Pfizer, outside the submitted work. C.P. is currently working at EISAI, Inc., but this publication is unrelated to her employment. M.M.R. received research support from Janssen Diagnostics, LLC for this work; research support from Novartis, Pfizer, Ipsen, TerSera, Merck, Pierre Fabre, Roche, AstraZeneca, Bristol-Myers Squibb, Bayer outside of the submitted work; consulting or advisory role to Ipsen/Debiopharm, Bristol-Myers Squibb, and Tolmar Pharmaceuticals. Mayo Clinic has received research funding from Eisai, Genentech, GRAIL, MSB, Merck, Seattle Genetics, and Tesaro; these funds were restricted to specific protocols/projects; M.C.L. has not received any personal remuneration. P.K.M has a consulting/advisory relationship with Genentech/Roche, Merck, Celltrion, and Immunomedics in the past 2 years and serves on the speakers’ bureau for Catamount Medical Education and Clinical Care Options; research funding to Duke from Glycomimetics, Abbvie, Novartis, Genentech/Roche, Veridex (for this study only), Innocrin, AstraZeneca, and Verily/Google Life Sciences; consulting/DSMB with Genentech/Roche. L.L.H. serves on the advisory boards and consults for Novartis, G1 therapeutics, Seattle Genetics, AstraZeneca, and Nanostring all outside of the current work. K.L.T. serves on the speakers’ bureau for Daiichi Sankyo, Immunomedics and advisory boards for Astrazeneca, GSK, Seattle Genetics, and PUMA. E.A. has received personal fees for expert testimony from Genentech/Roche, as well as for consulting from Apobiologix, Sandoz, and Novartis. I.E.K. serves on the advisory board/consults/received honoraria from Bristol Meyers Squibb, Daiichi/Sankyo, Macrogenics, Context Therapeutics, Taiho Oncology, Genentech/Roche, Seattle Genetics, AstraZeneca, Celltrion; institutional research funding/grants from Genentech/Roche, Pfizer; serves on the data monitoring board for NOVARTIS, Merck. P.J.G. has received funding from the Breast Cancer Research Foundation and support-in-kind (assays) from EPIC Sciences for CTC research outside of the submitted work. R.T.M. was a paid employee of Johnson and Johnson, the parent company of Janssen Diagnostics, LLC. D.F.H. received clinical and laboratory research support from Janssen Diagnostics, LLC, which supported this study, and more recently from MSB, the commercial vendor of CellSearch®. The University of Michigan (UM) holds patent US 8,790,878 B2 for which D.F.H. is designated as inventor, and that is licensed to MSB with annual royalties paid to UM and D.F.H. Outside the submitted work, D.F.H. holds stock options from InBiomotion, and serves on advisory boards for Cepheid, Freenome, CellWorks, Agendia, Salutogenic, EPIC Sciences, Oncocyte, Bioveca, and L-Nutra and UM has received research funding on his behalf from Merrimack, Eli Lilly, Puma Biotechnology, Pfizer, and AstraZeneca. All remaining authors have declared no competing interests.