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Peer-reviewedCC BYMolecular and clinical oncology

Nationwide real-world data on tumor-agnostic genomic companion diagnostics and comprehensive genomic profiling tests

  • Yasushi Yatabe1
  • Katsutoshi Oda2
  • Hiroya Taniguchi3
  • Kuniko Sunami4
  • Russell Miller5
  • Shotaro Yasuoka6
  • Ryosuke Watanabe6
6 affiliations
  1. 1Department of Diagnostic Pathology, National Cancer Center Hospital, Tokyo 104-0045, Japan
  2. 2Department of Obstetrics and Gynecology, The University of Tokyo, Tokyo 113-0033, Japan
  3. 3Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Aichi 464-8681, Japan
  4. 4Department of Laboratory Medicine, National Cancer Center Hospital, Tokyo 104-0045, Japan
  5. 5Syneos Health Japan K.K., Tokyo 100-7012, Japan
  6. 6Medical Affairs, MSD K.K., Tokyo 102-8667, Japan
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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.

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Cite

BibTeXRIS
BibTeX
@article{yatabe2026nationwide,
  title = {{Nationwide real-world data on tumor-agnostic genomic companion diagnostics and comprehensive genomic profiling tests}},
  author = {Yasushi Yatabe and Katsutoshi Oda and Hiroya Taniguchi and Kuniko Sunami and Russell Miller and Shotaro Yasuoka and Ryosuke Watanabe},
  journal = {Molecular and clinical oncology},
  year = {2026},
  month = oct,
  doi = {10.3892/mco.2026.2981},
  url = {https://europepmc.org/article/PMC/PMC13725746},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - Nationwide real-world data on tumor-agnostic genomic companion diagnostics and comprehensive genomic profiling tests
AU  - Yasushi Yatabe
AU  - Katsutoshi Oda
AU  - Hiroya Taniguchi
AU  - Kuniko Sunami
AU  - Russell Miller
AU  - Shotaro Yasuoka
AU  - Ryosuke Watanabe
PY  - 2026
DA  - 2026/10/16
JO  - Molecular and clinical oncology
DO  - 10.3892/mco.2026.2981
UR  - https://europepmc.org/article/PMC/PMC13725746
AB  - 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.
SN  - 2049-9450
SN  - 2049-9469
ER  -