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Test Report 

Each sample is analytically tested thrice using PCR. Samples with low/borderline levels of methylated Septin-9 may be detected in some but not in all three PCR runs.

According to test manufacturer’s specifications and FDA guidelines, a Positive result is called when at least two PCR runs detect methylated Septin-9, while a Negative result is called when none or one PCR run detects methylated Septin-9:

mSeptin9 PCR Runs
Result Reported
3 of 3 detected
Positive for methylated septin-9
2 of 3 detected
Positive for methylated septin-9
1 of 3 detected
Negative for methylated septin-9
0 of 3 detected
Negative for methylated septin-9

Patients with Negative results should be advised to continue participating in a recommended colorectal cancer screening program according to the screening guidelines by the Health Promotion Board.

A positive result is not confirmatory evidence for colorectal cancer. Methylated Septin-9 is associated with, and may aid in, the detection of colorectal cancer. Patients tested positive should speak to their healthcare provider for follow-up diagnostic colonoscopy for confirmation of the disease.

Test Performance 

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Last updated: 09 September 2022

  • About the Epi proColon 2.0 CE Test
    INTENDED USE The Epi proColon® 2.0 CE is a qualitative assay for the real-time PCR detection of methylated Septin-9 DNA in bisulfite converted DNA from human plasma samples. BIOMARKERS Epi proColon 2.0 CE uses PCR to detect the specific hyper-methylated DNA sequence of the Septin-9 (SEPT9) tumour suppressor gene promoter region. Presence of methylated Septin-9 is associated with, and may aid in, the detection of colorectal cancer. The test also detects the human actin beta (ACTB) housekeeping gene as an internal quality control to rule out possibility of false-negative results. APPROVED IVD BLOOD TEST Epi proColon: CE-Mark and US FDA Epi proColon 2.0 CE:* CE-Mark and China FDA *With improved test sensitivity and specificity
  • Who should be screened with Epi proColon 2.0 CE?
    Epi proColon 2.0 CE is indicated for average-risk people aged 50 and above. The test may use used to screen or monitor individuals with higher risk for colorectal cancer at the doctor's discretion. The test is not intended to replace screening tests recommended by the Health Promotion Board.
  • Age restrictions
    The clinical study reported by the test manufacturer included a demographically diverse group people between the ages of 50-85 who were considered to be of average-risk for colorectal cancer. Nonetheless, Acumen Diagnostics clinical laboratory does not restrict doctors to use the test for patients of any age.
  • Interpreting test results
    A positive result means that methylated Septin-9 DNA has been detected; methylated Septin-9 is associated with colorectal cancer. Epi proColon 2.0 CE is not a confirmatory test for the presence of colorectal cancer. Patients tested positive should be counselled by their doctors and be screened by colonoscopy for confirmation of the disease. A negative result indicates that methylated Septin-9 DNA was not detected. A negative test result is does not confirm the absence of polyps and colorectal cancer. Patients tested negative should be further advised by their doctors to continue to participate in the recommended screening program. Note that all results reported from the laboratory are valid unless otherwise stated on the test report and informed to the doctor. Tests are validated based on positive detection of the human ACTB gene used as the test internal quality control.
  • Type of blood collection tubes
    Collect 12ml fresh blood in K2EDTA purple-capped tubes ONLY. You may use multiple tubes for collection.
  • How to order the test
    Call 9173 3331 for Test Order Forms & consumables, and for sample collection (secondary number: 8339 8766). Store the blood samples in a refrigerator. Recommended temperature: 2-8 degree Celsius. The Acumen Despatch Team will pick up the sample within 4 hours for despatch straight to the laboratory. Despatch hours: 10AM - 10PM daily, including weekends, all PHs, and PH Eves.
  • Do you accept serum/plasma samples?
    For local (Singapore) institutions: Please send blood samples to the laboratory. Please call us at 9173 3331 should you intend to send plasma samples. For international institutions: Please send plasma samples. Please contact us for the workflow for plasma preparation and despatch requirements. We do not accept serum samples for the Epi proColon 2.0 CE test for colorectal cancer screening use.
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