{
  "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.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Diagnostic Pathology, National Cancer Center Hospital, Tokyo 104-0045, Japan",
    "Department of Obstetrics and Gynecology, The University of Tokyo, Tokyo 113-0033, Japan",
    "Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi 464-8681, Japan",
    "Department of Laboratory Medicine, National Cancer Center Hospital, Tokyo 104-0045, Japan",
    "Syneos Health Japan K.K., Tokyo 100-7012, Japan",
    "Medical Affairs, MSD K.K., Tokyo 102-8667, Japan"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 7,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Yasushi Yatabe"
    },
    {
      "affs": [
        1
      ],
      "name": "Katsutoshi Oda"
    },
    {
      "affs": [
        2
      ],
      "name": "Hiroya Taniguchi"
    },
    {
      "affs": [
        3
      ],
      "name": "Kuniko Sunami"
    },
    {
      "affs": [
        4
      ],
      "name": "Russell Miller"
    },
    {
      "affs": [
        5
      ],
      "name": "Shotaro Yasuoka"
    },
    {
      "affs": [
        5
      ],
      "name": "Ryosuke Watanabe"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/64t2xdvjm0jyf.bib",
  "cited_by": 0,
  "doi": "10.3892/mco.2026.2981",
  "fulltext_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13725746/?tool=EBI",
  "id": "64t2xdvjm0jyf",
  "issns": [
    "2049-9450",
    "2049-9469"
  ],
  "landing_url": "https://europepmc.org/article/PMC/PMC13725746",
  "language": "eng",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Articles"
    ],
    [
      "openalex",
      "1306|Cancer Genomics and Diagnostics"
    ]
  ],
  "openalex": "W7222506718",
  "pdf_url": "https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13725746/pdf/?tool=EBI",
  "pmcid": "PMC13725746",
  "pmid": "42973950",
  "published": "2026-10-16",
  "publisher": "Spandidos Publications",
  "ris": "https://research.draconitic.com/paper/64t2xdvjm0jyf.ris",
  "sources": [
    {
      "first_seen": "2026-11-03T15:20:51Z",
      "native_id": "PMC:PMC13725746",
      "source": "europepmc",
      "url": "https://europepmc.org/article/PMC/PMC13725746"
    },
    {
      "first_seen": "2026-11-04T12:24:01Z",
      "native_id": "PMC13725746",
      "source": "pmc",
      "url": "https://doi.org/10.3892/mco.2026.2981"
    },
    {
      "first_seen": "2026-11-04T15:20:48Z",
      "native_id": "MED:42973950",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42973950"
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  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:1306|Cancer Genomics and Diagnostics",
      "subfield": "oncology"
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  ],
  "title": "Nationwide real-world data on tumor-agnostic genomic companion diagnostics and comprehensive genomic profiling tests",
  "title_text": "Nationwide real-world data on tumor-agnostic genomic companion diagnostics and comprehensive genomic profiling tests",
  "type": "peer-reviewed",
  "updated_at": "2026-11-06T12:21:52Z",
  "url": "https://research.draconitic.com/paper/64t2xdvjm0jyf",
  "venue": "Molecular and clinical oncology",
  "versions": []
}