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Implementation Benchmark of Tumor-Agnostic Eligibility Signals Across Routine Comprehensive Genomic Profiling Platforms in Japan: A Nationwide C-CAT Analysis
Department of Medical Oncology and Palliative Medicine, Toyama University Hospital, 2630 Sugitani, Toyama 930-0194, Toyama, Japan
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Author to whom correspondence should be addressed.
Curr. Oncol. 2026, 33(6), 324; https://doi.org/10.3390/curroncol33060324 (registering DOI)
Submission received: 19 April 2026
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Revised: 22 May 2026
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Accepted: 29 May 2026
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Published: 30 May 2026
(This article belongs to the Section Oncology Biomarkers)
Simple Summary
Comprehensive genomic profiling (CGP) tests are now used in routine cancer care in Japan to look for molecular signals that may guide treatment discussions across cancer types. Clinicians and molecular tumor boards need realistic expectations about how often these signals are found in everyday testing. In this nationwide C-CAT analysis of 97,343 CGP-tested cases, at least one signal in the primary strict approved set was observed in 14.4% of cases. When two additional practice-oriented alterations were added, the expanded practical set rate was 16.3%. The observed frequencies differed by organ group, platform, and specimen/testing context, emphasizing the importance of interpreting CGP findings within the clinical testing pathway. This nationwide benchmark may support clinicians and molecular tumor boards in interpreting CGP reports and counseling patients in routine cancer genomic medicine.
Abstract
Routine precision oncology requires realistic benchmarks for tumor-agnostic eligibility signals observed in heterogeneous comprehensive genomic profiling (CGP) pathways. We performed a retrospective descriptive analysis of anonymized aggregated nationwide Center for Cancer Genomics and Advanced Therapeutics (C-CAT) data in Japan, including 97,343 CGP-tested cases summarized across five routine CGP platforms and categorized into 12 prespecified organ groups for analysis. The primary strict approved set endpoint was the case-level union of MSI-H, TMB-H, NTRK fusion/rearrangement, RET fusion/rearrangement, and ERBB2 amplification; the expanded practical set endpoint additionally included ALK fusion/rearrangement and BRAF V600E. The primary strict approved set endpoint was observed in 14,005 cases (14.4%), and the expanded practical set endpoint in 15,911 cases (16.3%), adding 1906 cases and increasing the observed rate by 2.0 percentage points. Signals varied across organ groups and platform/specimen contexts. TMB-H and ERBB2 amplification numerically dominated the primary set signal, whereas NTRK and RET fusion/rearrangement remained rare. These observed frequencies should be interpreted as case-level implementation signals surfaced through routine CGP rather than assay superiority evidence, biological prevalence estimates, or treatment-benefit data. This nationwide, platform-aware benchmark supports practical interpretation of tumor-agnostic eligibility signals in routine CGP practice in Japan.
