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Article History

Received: 10 February 2019

Accepted: 31 July 2019

First Online: 23 August 2019

Ethics approval and consent to participate

: Quorum Review Inc. (Seattle, WA) provided a human subject exemption letter covering this research. (reference QR #: 33472). Specifically, after review of the study it was deemed that the described activity does not constitute research involving human subjects as defined in 45 CFR §46.102. The study activities did not involve the collection of data through intervention or interaction with the individual because the activity utilized plasma samples collected from commercial biobanks and from other academic clinical studies. Furthermore, no identifiable private information was obtained because the aforementioned plasma samples were de-identified prior to receipt and no there is no access to the identifiers. Therefore, the previously conducted study activities did not constitute research involving human subjects.

: Not applicable

: NW, DW, TL, EA, MB, MB, DB, JC, AD, RE, SF, LH, JSJ, GO, JP, BR, GES, AS, CT, and LY are employees of Freenome.GP is an employee of Freenome and independent contractor/consultant for Palmetto GBA, MolDX.KN, AK, DD, BW, NB, EG, AT, YL and ISH are former employees of Freenome.Freenome is the sponsor of NCT03688906 (AI-EMERGE: Development and Validation of a Multi-analyte, Blood-based Colorectal Cancer Screening Test).