For Healthcare Professionals

ColonAiQ: Evidence-Based Insights for Healthcare Professionals

Colorectal cancer (CRC) remains a significant global health challenge, ranking among the leading causes of cancer-related deaths.

Early detection is crucial for improving patient outcomes and survival rates. ColonAiQ presents an innovative, non-invasive diagnostic solution that harnesses the power of circulating tumor DNA (ctDNA) methylation analysis. Here we present the scientific validation and performance data supporting ColonAiQ, demonstrating its efficacy and reliability in clinical settings.

Robust Performance Data

ColonAiQ has undergone rigorous validation across multiple studies and real-world clinical settings, demonstrating exceptional sensitivity and specificity.

Study 1: Published in Gastroenterology (December 2021)

  • Sensitivity: 86%
  • Specificity: 92%
  • Sample Size: 507
  • This multi-center clinical study was published in the Gastroenterology journal, which boasts an impressive impact factor (IF) of 33.88. The study highlighted ColonAiQ’s ability to detect CRC early and predict relapse.

Study 2: Chinese Clinical Trial Registration

  • Sensitivity: 87%
  • Specificity: 92%
  • Sample Size: 1,117
  • Conducted across top hospitals, including the Department of Colorectal Surgery at Fudan University Shanghai Cancer Center and the Endoscopy Center and Endoscopy Research Institute at Zhongshan Hospital.

Study 3: Performance Validation by Xiangya Medical Laboratory

  • Sensitivity: 89%
  • Specificity: 93%
  • Sample Size: 88
  • Xiangya Medical Laboratory, an official LDT qualified lab in China, validated ColonAiQ’s performance, achieving 100% positive and negative coincidence rates, and 100% consistency.

Comparative Efficacy

ColonAiQ significantly outperforms traditional markers such as FIT, CEA, and SEPT9, especially in early-stage CRC detection. The assay achieved an AUC of 0.93, corresponding to 86% sensitivity at 92% specificity.

ColonAiQ vs. CEA

  • All Stages: 88.3% vs. 59.7%
  • Stage I: 85.7% vs. 28.6%

ColonAiQ vs. SEPT9

  • ColonAiQ vs. SEPT9
  • All Stages: 85.5% vs. 38.2%
  • Stage I: 91.7% vs. 16.7%

ColonAiQ vs. FIT

  • All Stages: 85.1% vs. 72.0%
  • Stage I: 78.3% vs. 52.2%

Additional Findings and Applications

Beyond detection, ColonAiQ is also effective in predicting early relapse of CRC. An unpublished study involving 299 evaluable CRC patients post-surgery and post-adjuvant chemotherapy (ACT) showed that ColonAiQ significantly predicts and monitors relapse with a 17.5 times higher risk index post-surgery and a 13.8 times higher risk index after ACT.

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  • Bray, F., Ferlay, J., Soerjomataram, I., Siegel, R. L., Torre, L. A., & Jemal, A. (2018). Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians, 68(6), 394–424. https://doi.org/10.3322/caac.21492
  • Singapore Cancer Network (SCAN) guidelines for Systemic therapy of colorectal cancer. (2015). Annals, Academy of Medicine, Singapore/Annals of the Academy of Medicine, Singapore, 44(10), 379–387. https://doi.org/10.47102/annals-acadmedsg.v44n10p379
    https://doi.org/10.1053/j.gastro.2021.08.054
  • Cai, G., Cai, M., Feng, Z., Liu, R., Liang, L., & Zhou, P. (2021). A Multilocus Blood-Based Assay Targeting Circulating Tumor DNA Methylation Enables Early Detection and Early Relapse Prediction of Colorectal Cancer. Gastroenterology, 161(6), 2053-2056.e2. https://doi.org/10.1053/j.gastro.2021.08.054

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ColonAiQ is undergoing Health Sciences Authority (HSA) review for registration in Singapore and the Philippines.

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