Engel-Nitz, Nicole M.
Miller-Wilson, Lesley-Ann
Le, Lisa
Limburg, Paul
Fisher, Deborah A.
Funding for this research was provided by:
Exact Sciences Corporation
Article History
Received: 10 August 2022
Accepted: 28 April 2023
First Online: 26 May 2023
Declarations
:
: NMEN and LL are employees of Optum and shareholders in UnitedHealth Group. LAMW is an employee and shareholder of Exact Sciences at the time the study was conducted. PL served as Chief Medical Officer for Screening at Exact Sciences through a contracted services agreement with Mayo Clinic at the time the study was conducted; PL and Mayo Clinic had contractual rights to receive royalties through that agreement. PL is currently an employee of Exact Sciences. DAF has been a consultant with Exact Sciences and Guardant Health. DAF was employed at Duke University at the time of the study and is currently employed by Eli Lilly and Company.
: Institutional review board approval or waiver of approval was not required for this study because the study data were secondary and de-identified in accordance with the United States Department of Health and Human Services (HHS Privacy Rule’s requirements for de-identification codified at 45 C.F.R. § 164.514(b). Throughout the process, patient privacy was preserved, and researchers complied strictly with all applicable Health Insurance Portability and Accountability Act data management rules and the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
: Not applicable.