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Since the approval of the first poly adenosine diphosphate (ADP) ribose polymerase inhibitor (PARPi), olaparib for platinum-sensitive relapsed high grade ovarian cancer, with either germline or somatic BRCA1/2 deleterious variants, the strategies for BRCA1/2 testing are dynamically changing. In fact, along with germline assay, patients are now tested for tumor BRCA1/2 also above all for treatment decisions. In fact, it is reported as by tumor BRCA analysis we can identify 3–9% more mutated women which can therefore benefit from PARPi therapy. Although this new type of approach looks like challenging, in particular due to the technical and analytical difficulties regarding low quality DNA deriving from formalin-fixed paraffin-embedded specimens, the new CE-IVD on NGS-based pipelines, can overcome these issues, allowing specialized molecular laboratories to ensure high quality results and perform the best test settings. Nevertheless, each new NGS pipeline (CE-IVD or in house) should be validated using peculiar samples along with commercially available reference and certified materials, before being introduced in routine settings. The validation set should be appropriately chosen in order to provide unequivocal data regarding robustness of each NGS tBRCA pipeline. Therefore, in order to harmonize the patient and laboratory path, a group of Italian Scientific Societies [Italian Society of Clinical Chemistry (SIBioC), Italian Association of Medical Oncology (AIOM), Italian Association of Clinical Pathology (SIAPEC), Italian Society of Human Genetics (SIGU)] provided the present recommendations which are aimed to guide all professionals (oncologists, gynaecologists, clinical and laboratory geneticists, clinical molecular biologists and pathologists). The intersociety group is confident that the present paper can offer all ovarian cancer women a well-organized pathway of diagnosis and treatment.

Introduction: COVID-19 has disrupted the global health care system since March 2020. Lung cancer (LC) patients (pts) represent a vulnerable population highly affected by the pandemic. This multicenter Italian study aimed to evaluate whether the COVID-19 outbreak had an impact on access to cancer diagnosis and treatment of LC pts compared with pre-pandemic time. Methods: Consecutive newly diagnosed LC pts referred to 25 Italian Oncology Departments between March and December 2020 were included. Access rate and temporal intervals between date of symptoms onset and diagnostic and therapeutic services were compared with the same period in 2019. Differences between the 2 years were analyzed using the chi-square test for categorical variables and the Mann–Whitney U test for continuous variables. Results: A slight reduction (−6.9%) in newly diagnosed LC cases was observed in 2020 compared with 2019 (1523 versus 1637, P = 0.09). Newly diagnosed LC pts in 2020 were more likely to be diagnosed with stage IV disease (P < 0.01) and to be current smokers (someone who has smoked more than 100 cigarettes, including hand-rolled cigarettes, cigars, cigarillos, in their lifetime and has smoked in the last 28 days) (P < 0.01). The drop in terms of new diagnoses was greater in the lockdown period (percentage drop −12% versus −3.2%) compared with the other months included. More LC pts were referred to a low/medium volume hospital in 2020 compared with 2019 (P = 0.01). No differences emerged in terms of interval between symptoms onset and radiological diagnosis (P = 0.94), symptoms onset and cytohistological diagnosis (P = 0.92), symptoms onset and treatment start (P = 0.40), and treatment start and first radiological revaluation (P = 0.36). Conclusions: Our study pointed out a reduction of new diagnoses with a shift towards higher stage at diagnosis for LC pts in 2020. Despite this, the measures adopted by Italian Oncology Departments ensured the maintenance of the diagnostic-therapeutic pathways of LC pts.