Cologuard®
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
Cologuard provides a convenient at-home test kit that comes with built-in patient navigation support available from 6 AM to 10 PM CT. This includes assistance with questions and reminders for test completion, facilitating sample collection in the privacy of one's home.
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.
Methodology
PCR-based
Biomarkers
Result Turnaround Time
Not provided.
Related Documents
For more information, please review the documents below
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.
Causes for Rejection
Samples not collected according to instructions, damaged kit components, or transit delays exceeding the stabilizing buffer's capability.