Cologuard Plus™ test
Use
The Cologuard Plus test is designed for at-home colorectal cancer screening in average-risk patients aged 45 and older. It is based on substantial data from the BLUE-C study, which involved more than 20,000 individuals. The test aims to detect colorectal cancer (CRC) with high accuracy and specificity, reducing unnecessary follow-up procedures. Specifically, it detects 95% of CRC cases and 74% of high-grade dysplasia, which are pre-cancerous growths at risk of progressing to cancer. The test is notable for being the most accurate noninvasive CRC screening test reported in current studies.
Special Instructions
The Cologuard Plus test offers the convenience of at-home collection, eliminating the need for preparation, dietary restrictions, or sedation. It is sent directly to the patient's home and utilizes Exact Sciences' ExactNexus platform to streamline ordering, results delivery, and patient navigation processes.
Limitations
While the Cologuard Plus test provides high accuracy, it is important to note that it may not detect all cases of CRC or polyps. Some positive results may not be cancerous (false positives), and it may not catch all types of high-grade dysplasia. Patients with positive tests need follow-up diagnostic procedures. Clinical decision-making should consider these aspects alongside other clinical evaluations.
Methodology
Other
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
No specific preparation is required for the collection of the stool sample at home. The kit, once received, should be used according to the instructions provided to ensure accuracy.
Patient Preparation
No preparation or dietary restrictions are necessary.