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Usha Menon 1,*, Aleksandra Gentry-Maharaj 1, Matthew Burnell 1, Andy Ryan 1, Jatinderpal K Kalsi 2,3, Naveena Singh 4, Anne Dawnay 5, Lesley Fallowfield 6, Alistair J McGuire 7, Stuart Campbell 8, Steven J Skates 9, Mahesh Parmar 1, Ian J Jacobs 10

1 MRC Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK
2 Department of Women’s Cancer, Institute for Women’s Health, University College London, London, UK
3 CRUK UCL Centre, UCL Cancer Institute, London, UK
4 Department of Cellular Pathology, Barts Health NHS Trust, London, UK
5 Department of Clinical Biochemistry, Barts Health NHS Service Trust, London, UK
6 Sussex Health Outcomes Research and Education in Cancer (SHORE-C), Brighton and Sussex Medical School, University of Sussex, Brighton, UK
7 London School of Economics and Political Science, London, UK
8 Create Health, London, UK
9 Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA
10 Department of Women’s Health, University of New South Wales, Sydney, NSW, Australia
* Corresponding author Email: u.menon@ucl.ac.uk

Disclosure of interests

Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi.org/10.3310/BHBR5832.

Primary conflicts of interest: All authors have completed the unified competing interest form at www.icmje.org/coi_disclosure. pdf (available on request from the corresponding author) and declare (1) no financial support for the submitted work from anyone other than their employer; (2) no financial relationships with commercial entities that might have an interest in the submitted work; (3) no spouses, partners, or children with relationships with commercial entities that might have an interest in the submitted work; and (4) no non-financial interests that may be relevant to the submitted work. Usha Menon has stock ownership awarded by University College London (UCL) in Abcodia, which holds the licence for ROCA. She has received grants from the Medical Research Council (MRC), Cancer Research UK, the National Institute for Health and Care Research (NIHR), and The Eve Appeal. She holds patent number EP10178345.4 for Breast Cancer Diagnostics. Mahesh Parmar has received grants and Aleksandra Gentry-Maharaj, Matthew Burnell, Jatinderpal Kalsi and Andy Ryan have been funded by grants from MRC, Cancer Research UK, NIHR, and The Eve Appeal. Steven J Skates co-developed ROCA in 1995. It was patented by Massachusetts General Hospital and Queen Mary University of London and is owned by these universities. The patent has expired. Massachusetts General Hospital and Queen Mary University of London granted a licence to ROCA to Abcodia in 2014. He reports stock options from SISCAPA Assay Technologies. Ian J Jacobs reports grants from Eve Appeal Charity, Medical Research Council, Cancer Research UK, and NIHR during the conduct of the study. He co-invented the ROCA in 1995, it was patented by Massachusetts General Hospital and Queen Mary University of London and is owned by these universities. Massachusetts General Hospital and Queen Mary University of London granted a licence to ROCA to Abcodia in 2014. Ian J Jacobs is non-executive director, shareholder, and consultant to Abcodia and has rights to royalties from sales of the ROCA. He founded (1985), was a trustee of (2012–14), and is now an Emeritus trustee (2015–present) of The Eve Appeal, one of the funding agencies for UKCTOCS. Alistair McGuire was a member of NIHR HTA and EME Editorial Board from 1 April 2012 to 31 March 2022. All other authors declare no competing interests.

All findings reported in this manuscript have been published previously and have been referenced. Where tables or figures have been reproduced from the original article, permission for use has been sought from the relevant journal.

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