For Laboratory Partners

Innovative qPCR-based blood test for Colorectal Cancer Screening

ColonAiQ® is a cutting-edge, PCR-based multi-gene methylation detection kit designed for the early detection, relapse prediction, and monitoring of colorectal cancer (CRC). This advanced assay uses blood samples to identify methylation patterns in specific genes associated with CRC, making it a non-invasive, highly sensitive, and specific method for screening and detection.

Technical Overview

ColonAiQ® targets multiple genes, including Septin9 (regions 1 & 2), BCAT1, IKZF1, and VAV3. The detection process involves several key steps:
  • Whole blood samples (minimum 8mL) are collected using EDTA or Cell-Free DNA Blood Collection Tubes.
  • Plasma is separated from whole blood via a two-step centrifugation process:
    • First, centrifuge at 1600 x g for 15 minutes at 4°C.
    • Second, centrifuge the plasma at 16,000 x g for 10 minutes at 4°C.
  • Store the separated plasma at -25°C to -15°C for up to 4 weeks or at -70°C for up to 12 months.
  • Utilize 4mL of plasma for cell-free DNA (cfDNA) extraction using automated systems like NAE24 or manual kits.
  • The process includes digestion, binding, cleaning, and elution steps.
  1.  
  • Perform bisulfite conversion on the extracted cfDNA to differentiate between methylated and unmethylated DNA.
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  • Pre-amplification increases the number of DNA templates to ensure sufficient material for the qPCR analysis.
  • The qPCR is conducted using systems such as the ABi 7500 or QuantStudio, focusing on the specified gene targets.

Performance and Clinical Utility

ColonAiQ® demonstrates remarkable sensitivity and specificity in detecting CRC, outperforming other methods such as FIT, CEA, and single-gene tests like Septin9. In clinical studies, ColonAiQ® achieved a sensitivity of 86% and specificity of 92%, making it a reliable tool for early-stage CRC detection. It also shows significant promise in monitoring for relapse post-surgery and post-chemotherapy.

Setting Up a ColonAiQ® Testing Facility

For laboratories interested in providing ColonAiQ® screening tests, the following setup is required:

  • Blood collection tubes (EDTA and Cell-Free DNA)
  • Centrifuges for plasma separation (low-speed and high-speed centrifuges)
  • Refrigeration units capable of maintaining -25°C to -15°C and -70°C temperatures
  • Automated nucleic acid extraction systems (e.g., NAE24)
  • Manual extraction kits as an alternative
  • Bisulfite conversion kits
  • PCR thermal cyclers for DNA amplification
  • Real-time qPCR systems (e.g., ABi 7500, QuantStudio)
  • Qubit or similar quantification systems for DNA measurement
  • Biosafety cabinets for handling samples
  • Pipettes and other standard laboratory equipment
  • Methylation detection kits for human colorectal cancer (ColonAiQ®)

Reagents for ColonAiQ® Operation

DNA Extraction

  • Qiagen reagent
  • Singlera reagent (magnetic beads) with automatic workstation

Bisulfite Conversion

  • ZYMO reagent (D5031)
  • Singlera reagent (Column)

Adapted Platforms

  • Applied Biosystems 7500 (Recommended)
  • Applied Biosystems QuantStudio 5
  • Other domestic PCR analyzers

Amplification

SGI (ColonAiQ reagents)

By ensuring these components are in place, labs can effectively implement ColonAiQ® testing, providing high-quality, reliable CRC screening and monitoring services to their patients. This not only enhances early detection but also improves patient outcomes through timely intervention and treatment.
If you want to offer ColonAiQ® to your patients kindly contact us.
  • 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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Saver’s Med Pte Ltd is the exclusive distributor for Singlera’s ColonAiQ® in Singapore and the Philippines.

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

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