Here are some frequently asked questions about Exact Sciences Laboratories. For frequently asked questions about Cologuard, click here to visit Cologuard.com.
What is Cologuard?
Cologuard is an in vitro diagnostic qualitative screening device that utilizes a multi-target approach to detect DNA and hemoglobin markers associated with colorectal cancer (CRC), as well as pre-malignant colorectal neoplasia. Three independent categories of biomarkers are targeted and provide an additive association with CRC and pre-malignant neoplasms. Patients use the Cologuard Collection Kit, consisting of a container for collection of stool for DNA testing and a separate sampler for collection of stool for hemoglobin testing. Both of these samples are required to obtain a Cologuard result.
Is Cologuard FDA approved?
Yes, Cologuard was approved by the FDA on August 11, 2014 as an In Vitro Diagnostic Screening Device following the most rigorous review possible for a medical device, Pre-Market Approval (PMA).
How is Cologuard processed in the laboratory?
Once the collection kit is received, it is accessioned into the laboratory information system, collection requirements are assessed, and then the kit is tested using the Cologuard processes.
Cologuard test processing includes:
- Stool DNA isolation from the sample
- Automated DNA purification
- Automated setup of Quantitative Allele-Specific Real-time Target and Signal amplification (QuARTS™) reaction.*
- In parallel the sample is processed on a Semi-Automated Enzyme-Linked Immunosorbent Assay (ELISA) for hemoglobin testing
- Result calculation using the Cologuard algorithm
Once the test arrives at Exact Sciences Laboratories, how long does it take for the healthcare provider to receive results?
Once the lab receives the patient’s Collection Kit it usually takes about two weeks for the laboratory to test the sample and report the result back to the provider.
How will the test results be presented?
The Cologuard test result will be either positive or negative. We recommend that a licensed healthcare provider evaluate Cologuard results and discuss with each patient.
A positive result does not necessarily mean your patient has cancer. It means that Cologuard may have detected the targeted biomarkers which are associated with CRC or advanced adenoma in the stool. False positives and false negatives occur with Cologuard and appropriate follow-up is important. Patients with a positive result should have a colonoscopy. Patients with a negative colonoscopy following a positive Cologuard result do not require additional clinical evaluation.
A negative result indicates a lower likelihood of CRC or advanced adenoma. False positives and false negatives occur with Cologuard and appropriate follow-up is important. Patients with a negative result should continue in a screening program appropriate for the patient. Cologuard is recommended by the ACS every 3 years.**
How is billing handled?
Exact Sciences Laboratories handles billing for Cologuard, as the only lab providing this service.
What are the benefits and risks of the Cologuard Test?
Cologuard detects 92% of cancers and 69% of high-risk precancerous lesions (high-grade dysplasia). Cologuard is a noninvasive, stool DNA (sDNA) test to screen for colorectal cancer. The Cologuard Collection Kit lets the patient collect their sample at home. There are no dietary restrictions and no bowel preparation is required.
Cologuard may produce false negative or false positive results. A false positive result occurs when Cologuard produces a positive result, even though a colonoscopy will not find cancer or precancerous polyps. A false negative result occurs when Cologuard does not detect a precancerous polyp or colorectal cancer even when a colonoscopy identifies the positive result.
Patients should be advised of the caution listed in the Cologuard Patient Guide and Patient Brochure. Patients should NOT drink the preservative liquid.
The risks related to using the Cologuard Collection Kits are low, with no serious adverse events reported among people in a clinical trial. Patients should be careful when opening and closing the lids to avoid the risk of hand strain.
Where can I get more information?
Please call Exact Sciences at 1-844-870-8870. For patient information, visit the Cologuard patient website.
References
*QuARTS™ is a trademarked technology that utilizes the established molecular biology techniques of real-time PCR for DNA amplification combined with invasive cleavage chemistry to perform allele-specific signal amplification.
**Wolf AMD, et al. CA Cancer J Clin. 2018;68(4):250-281.
