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<p>Endoscopy is the gold standard for diagnosing gastric cancer (GC), but its invasiveness limits widespread participation and has not substantially reduced GC-related mortality. This study developed and validated a blood-based digital PCR assay for early GC detection using DNA methylation biomarkers. Genome-wide methylation profiles from over 10,000 samples were screened, and two candidates were validated in GC cell lines, tumors, matched non-cancerous tissues, and plasma. Plasma from 60 GC patients, including 38 with stage I disease, and 40 healthy controls was analyzed with a digital PCR assay targeting the selected biomarkers, using <i>ACTB</i> as a reference. <i>GHR</i> and <i>GLRB</i> methylation were identified as novel GC biomarkers, showing consistent hypermethylation in GC cell lines and tumor tissues. In plasma, the two-marker assay achieved 83.3% (95% CI 71.5%–91.7%) sensitivity and 90% (95% CI 76.3%–97.2%) specificity, clearly outperforming carcinoembryonic antigen (CEA) testing (10.0%; 95% CI 3.8%–20.5%). Incorporation of <i>GATM</i> methylation as a third marker increased sensitivity to 86.7% (95% CI 75.4%–94.1%) overall and 81.6% (95% CI 65.7%–92.3%) for stage I disease, while maintaining 90.0% specificity. This methylation-based digital PCR assay enabled accurate, noninvasive detection of GC, particularly at early stages, and may facilitate timely diagnosis and curative treatment.</p>

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Plasma-based digital PCR assay for early detection of gastric cancer using multiple methylation biomarkers

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月11日

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  • Yun Young Lee,
  • Joon An,
  • Jinil Han,
  • Youngho Moon,
  • Sang-Il Lee

摘要

Endoscopy is the gold standard for diagnosing gastric cancer (GC), but its invasiveness limits widespread participation and has not substantially reduced GC-related mortality. This study developed and validated a blood-based digital PCR assay for early GC detection using DNA methylation biomarkers. Genome-wide methylation profiles from over 10,000 samples were screened, and two candidates were validated in GC cell lines, tumors, matched non-cancerous tissues, and plasma. Plasma from 60 GC patients, including 38 with stage I disease, and 40 healthy controls was analyzed with a digital PCR assay targeting the selected biomarkers, using ACTB as a reference. GHR and GLRB methylation were identified as novel GC biomarkers, showing consistent hypermethylation in GC cell lines and tumor tissues. In plasma, the two-marker assay achieved 83.3% (95% CI 71.5%–91.7%) sensitivity and 90% (95% CI 76.3%–97.2%) specificity, clearly outperforming carcinoembryonic antigen (CEA) testing (10.0%; 95% CI 3.8%–20.5%). Incorporation of GATM methylation as a third marker increased sensitivity to 86.7% (95% CI 75.4%–94.1%) overall and 81.6% (95% CI 65.7%–92.3%) for stage I disease, while maintaining 90.0% specificity. This methylation-based digital PCR assay enabled accurate, noninvasive detection of GC, particularly at early stages, and may facilitate timely diagnosis and curative treatment.