Cologuard®

Clinical Use

Use

Cologuard is a stool DNA-based colorectal cancer screening test designed for average-risk individuals aged 45 and older. It utilizes a multi-marker approach to analyze stool samples for specific DNA markers, as well as blood in the stool, to identify colon cancer at early treatable stages. The test offers a noninvasive, at-home collection process without the need for special preparation, dietary changes, or cessation of medication. It is supported by extensive clinical research and collaboration with Mayo Clinic.

Special Instructions

Not provided.

Limitations

The test is intended for use by average-risk individuals for colorectal cancer screening and may not be suitable for those with a high risk of colorectal cancer due to certain pre-existing conditions or genetic predispositions. False positives and false negatives may occur, necessitating follow-up with diagnostic procedures like colonoscopy for confirmation of results. The accuracy levels of the DNA markers and hemoglobin detection might vary, influenced by the sample's stability and the patient's individual biological factors.

Test Details

Methodology

PCR-based

Biomarkers

NDRG4, BMP3, KRAS

Gene

SNV/Indel

Mutation • Categorical (e.g., Positive / Negative / Indeterminate)

Hemoglobin

Protein

ELISA

Other • Binary (Detected / Not Detected)

Result Turnaround Time

0 days

Specimen

Stool

Volume

Not provided

Minimum Volume

Not provided

Collection Instructions

Collect the stool sample using the Cologuard at-home kit as instructed in the accompanying guidelines. No dietary or medication changes are necessary for sample collection.

Patient Preparation

No special preparation is required prior to taking the Cologuard test. The patient can maintain their regular diet and medication routine.

Storage Instructions

Ensure that the stool sample remains secure in the provided container until delivered to the processing center. The stabilizing buffer in the kit will help maintain DNA integrity during transit.