Cologuard- Colorectal Screening Test

It is both alarming and concerning to see patients diagnosed with colorectal cancers at a much younger age. In most countries average risk screening with either FOBT/FOBi or flexisigmoidoscopy won’t be offered until patient turn 50. FOBT/FOBi are limited by their low sensitivity and specificity resulting missed cancers/advanced polyps or patients undergoing invasive investigations with associated complication risks. So what is actually out there?

 

Cologuard utilizes a multi-target approach to detect DNA and hemoglobin biomarkers associated with colorectal cancer and precancer. Cutting-edge stool DNA (sDNA) technology for cancer and precancer detection means more curable-stage cancers can be found than with fecal blood alone.

 

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DNA BIOMARKER DETECTION

 

Amplification and detection of methylated target DNA (NDRG4, BMP3), KRAS point mutations, and ACTB (a reference gene for quantitative estimation of the total amount of human DNA in each sample) is performed using the Quantitative Allele-specific Real-time Target and Signal Amplification (QuARTS™) technology.

Multiplexed QuARTS reactions are processed using a real-time cycler with each biomarker (NDRG4, BMP3, KRAS, and ACTB) monitored separately through independent fluorescent detection channels.

 

HEMOGLOBIN BIOMARKER DETECTION

 

The stool sample is prepared and analyzed for fecal occult blood in a quantitative Enzyme-Linked Immunosorbent Assay (ELISA) that determines the concentration of hemoglobin in the sample.

 

PIVOTAL CLINICAL STUDY

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In a clinical study published in 2014 that included more than 90 sites throughout the US and Canada, Cologuard’s stool DNA technology was evaluated in 10,000 participants:
  • Evaluated Cologuard for detecting colorectal cancer and precancer
  • One of the largest colorectal cancer studies ever conducted
  • Compared Cologuard to a leading fecal immunochemical test (FIT)*
  • Prospective cross-sectional study

 

 

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