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Article History

Received: 12 July 2022

Accepted: 23 September 2022

First Online: 12 October 2022

Declarations

:

: AMS Bio (worldwide) samples obtained under local EC/IRB-approved protocols, de-identified and de-linked to patient records, and under approvals for transfer of materials to third parties.

: Discovery Life Sciences (USA): Two (HBF_0018 and HBF_0019) are from autopsies performed in 2017, collected under informed consent. HBF_022 was collected under waiver of consent: after 10 years storage under IRB approval to use such specimens for research by waiver of consent per federal regulations as long as the FFPE block has met the 10-year storage requirement.

: Azenta Life Sciences (France): NSCLC_151 and NSCLC_152. Article L.1131-1-1 of the public health code of French law explicitly allows opt-out consent where genetic analysis is based on the reuse of already collected samples. The patient was informed through an information notice of the use of their samples for research and was able to object to this. The protocols and regulations of Cypath (supplier to Azenta Life Sciences) have been approved by the French Ministry of Health and Research (declaration number: DC-2020-4290, cession authorization number AV-2020-4288).

: Not applicable.

: All authors are employees of Biofidelity Ltd a privately held company and may hold stock or stock options. Biofidelity has filed patent applications on aspects of this research (WO2021130494A1).