BACKGROUND: Poly (ADP ribose) polymerase inhibitors (PARPis) are a treatment option for patients with advanced high-grade serous or endometrioid ovarian carcinoma (OC). Recent guidelines have clarified how homologous recombination deficiency (HRD) may influence treatment decision-making in this setting. As a result, numerous companion diagnostic assays (CDx) have been developed to identify HRD. However, the optimal HRD testing strategy is an area of debate. Moreover, recently published clinical and translational data may impact how HRD status may be used to identify patients likely to benefit from PARPi use. We aimed to extensively compare available HRD CDx and establish a worldwide expert consensus on HRD testing in primary and recurrent OC. METHODS: A group of 99 global experts from 31 different countries was formed. Using a modified Delphi process, the experts aimed to establish consensus statements based on a systematic literature search and CDx information sought from investigators, companies and/or publications. RESULTS: Technical information, including analytical and clinical validation, were obtained from 14 of 15 available HRD CDx (7 academic; 7 commercial). Consensus was reached on 36 statements encompassing the following topics: 1) the predictive impact of HRD status on PARPi use in primary and recurrent OC; 2) analytical and clinical validation requirements of HRD CDx; 3) resource-stratified HRD testing; and 4) how future CDx may include additional approaches to help address unmet testing needs. CONCLUSION: This manuscript provides detailed information on currently available HRD CDx and up-to-date guidance from global experts on HRD testing in patients with primary and recurrent OC.

Association de Recherche Cancers Gynécologiques Groupe d'Investigateurs Nationaux pour l'Etude des Cancers de l'ovaire et du Sein Paris France

Centre for Cancer Research The Westmead Institute for Medical Research Sydney NSW Australia; Faculty of Medicine and Health The University of Sydney Sydney NSW Australia; Department of Gynaecological Oncology Westmead Hospital Sydney NSW Australia; The Daffodil Centre The University of Sydney a joint venture with Cancer Council NSW Sydney NSW Australia

Coordinator of Gen and Tiss GFCO Université Paris Saclay Gustave Roussy Cancer Campus Inserm U981 Villejuif France; Cancer Genetics Laboratory Medical Biology and Pathology Department Gustave Roussy Cancer Campus Villejuif France

Department of Gynecological Oncology Fudan University Shanghai Cancer Center Shanghai China

Department of Medical Oncology Institut régional du Cancer de Montpellier Montpellier France

Department of Medical Oncology Institut régional du Cancer de Montpellier Montpellier University Montpellier France

Department of Pathology Hospital Universitari Arnau de Vilanova IRBLLEIDA University of Lleida Lleida Spain; Department of Pathology Hospital Universitari de Bellvitge IDIBELL University of Barcelona Barcelona Spain; European Society of Pathology Belgium

Department of Urology and Gynecology Istituto Nazionale Tumori di Napoli IRCCS Fondazione Pascale Napoli Italy

Division of Cancer and Ovarian Cancer Action Research Centre Department of Surgery and Cancer Imperial College London London UK

Division of Experimental Oncology European Institute of Oncology IRCCS Milan Italy

Division of Gynaecological Oncology University Hospitals Leuven Leuven Cancer Institute Leuven Belgium; Belgium and Luxembourg Gynaecological Oncology Group Leuven Belgium

Division of Human Genetics National Health Laboratory Service Universitas Hospital Bloemfontein South Africa; Division of Human Genetics Faculty of Health Sciences University of the Free State Bloemfontein South Africa

European Society of Pathology Belgium; The Fingerland Department of Pathology Faculty of Medicine Charles University and University Hospital Hradec Kralove Czech Republic

Federal University MG Brazilian Group of Gynecologic Oncology Oncoclínicas DOM Oncologia Brazil

Groupe d'Investigateurs Nationaux pour l'Etude des cancers de l'ovaire et du sein Paris France; Medical Oncology Centre Léon Bérard and Université Claude Bernard Lyon Lyon France

Gynecologic Oncology Program European Institute of Oncology IRCCS Milan Italy; Department of Medicine and Surgery University of Milan Bicocca Milan Italy

Institute of Pathology School of Medicine and Health Technical University Munich Munich Germany

Medical Oncology Service Vall d'Hebron Institute of Oncology Vall d'Hebron Barcelona Hospital Campus Barcelona Spain

Société Française de Médecine Prédictive et Personnalisée Montpellier France; Department of Biology and Pathology Centre de Lutte Contre le Cancer Jean Perrin Imagerie Moléculaire et Stratégies Théranostiques Université Clermont Auvergne UMR 1240 INSERM UCA Clermont Ferrand France; Cours St Paul Saint Paul Réunion France

Texas Oncology US Oncology Network The Woodlands TX USA

The Royal Marsden NHS Foundation Trust and Institute of Cancer Research London UK

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