Geneo study: Comprehensive genomic profiling versus limited local reimbursed NGS panels within the belgian Precision initiative.

BACKGROUND: Molecular diagnostics in oncology is shifting from targeted NGS panels to comprehensive genomic profiling (CGP), which detects a broader range of alterations and expands access to clinical trials and therapies. METHOD: This study assessed the added value of CGP compared with current Belgian practice using local NGS panels covering a minimally required set of genes set by cancer type. We prospectively recruited 1000 patients with metastatic or locally advanced cancer across 13 Belgian hospitals. Tumor tissue or liquid biopsies were analyzed with FoundationOne CDx assays. The added value over reimbursed local NGS panels was measured by additional treatments recommendations issued by the national molecular tumor board (nMTB). RESULTS: CGP was successful in 93% of patients. Among patients tested with both local NGS and CGP, 48% received at least one additional nMTB recommendations based on CGP. Overall, CGP more than doubled targeted therapy recommendations compared with local NGS panels, with nMTB providing recommendations for 61% of patients. Of the evaluable patients (n = 586), 23% received the nMTB recommended therapy. Non-adherence was due to treatment unavailability (25%), rapid clinical deterioration (24%), patient choice (17%), or physician decision (15%). Among those treated according to nMTB recommendations, the majority participated in clinical trials (48%), followed by standard of care treatments (35%) and off-label therapies (16%). CONCLUSIONS: The GeNeo study demonstrated that CGP provides added clinical value by significantly increasing the detection of actionable alterations and targeted therapy recommendations compared with small reimbursed local NGS panels.