Nationwide real‑world data on tumor‑agnostic genomic companion diagnostics and comprehensive genomic profiling tests
Year: 2026
Type: article
Study design: Observational Study
Abstract: The present study aimed to assess the utilization of biomarker testing, including companion diagnostics and comprehensive genomic profiling (CGP), in Japan and to highlight the value of large-scale real-world database analysis in precision oncology. Claims data from the Medical Data Vision Co., Ltd. database, covering ~40 million patients across 26% of advanced treatment hospitals in Japan, were retrospectively analyzed. Biomarker tests for five genomic biomarkers (BRAF, BRCA1/2, KRAS/NRAS, homologous recombination deficiency and microsatellite instability (MSI)) were evaluated in patients with a confirmed diagnosis of one of 11 common cancer types, a cancer of unknown primary origin (CUP) or a rare cancer, who underwent at least one biomarker test between December 2018 and March 2022. A total of 41,191 biomarker tests were recorded in 28,382 patients, with test volumes increasing markedly between 2018 and 2021. MSI testing was the most common (70.1% of patients), followed by RASKET-B for KRAS/NRAS (25.5%) and BRAF (23.9%). Patients with colorectal cancer frequently underwent multiple tests (42.8%) and distinct testing sequences were observed in gynecological cancer. CGP was more commonly performed on tissue-based samples than through liquid biopsy, particularly in rare cancer (38.5%) and CUP (11.4%). Notably, ~40% of patients received a new treatment after CGP, whereas only 1.7% initiated indicated therapy after MSI testing. The mean time to subsequent treatment initiation from the index date was 70.4 days. In conclusion, the present nationwide real-world study provides an early comprehensive overview of the prevalence and trends of biomarker testing in Japan, and reveals a gap between testing and treatment implementation. Although testing is increasing, its effective clinical use remains limited. Large-scale database analyses may help identify barriers and support strategies to improve the integration of biomarker testing into treatment decision-making, ultimately advancing precision oncology.
Source: Molecular and Clinical Oncology
Language: English
Subfield: Cancer Research
Domain: Life Sciences
Open Access status: diamond
OpenAlex ID: W7222506718