In 2025, Cologuard, an at-home colorectal cancer screening test, got an upgrade.
Called Cologuard Plus, the new test is a more accurate version of the original Cologuard, which was first approved in 2014. It looks for a smaller, more optimized set of biomarkers, which allows it to detect more cancers and reduce false positives—and unnecessary follow-up colonoscopies.
Is Cologuard Plus Better Than the Original?
Both the original and new Cologuard tests are for people 45 and older who are at average risk of colorectal cancer, meaning those without a personal or family history of the cancer.
They use a stool sample that patients collect at home with a treated paper that fits over the toilet. The sample is then placed in a provided container and sent back to the company with a prepaid label.
How Effective Is Cologuard Plus?
The Food and Drug Administration (FDA) approved Cologuard Plus based on findings from a 2024 trial that included 20,000 participants. Researchers compared Cologuard Plus with a fecal immunochemical test (FIT), which screens for early signs of colon cancer by detecting hidden blood in stool. Unlike FIT, Cologuard screens for blood and genetic abnormalities.
All trial participants also underwent a colonoscopy to confirm the test results. According to the trial results, Cologuard Plus detected 94% of cancers compared to 67% for FIT. It correctly identified individuals without colorectal cancer or advanced precancerous polyps 93% of the time, while FIT did so in 96% of cases.
Advantages
While Cologuard and Cologuard Plus were not compared head-to-head in the trial, there’s a key difference between the two, according to a spokesperson from the test manufacturer, Exact Sciences. People using the original Cologuard have four days to send their sample, while those using Cologuard Plus have six days because of different preservatives.
The spokesperson said Cologuard Plus may be as much as 30% more accurate than Cologuard. The new test is also expected to have a lower rate of false positives than Cologuard. Currently, the false positive rate for Cologuard is 13%, according to the company.
“The recommendation for all non-colonoscopy screening tests is for people who get a positive result to have a colonoscopy to confirm or rule out colorectal cancer,” Michael Sapienza, CEO of the Colorectal Cancer Alliance, told Verywell. “Reducing false positives is important because it reduces worry and could add to the number of people opting to take the screening tests.”
Importantly, the trial included people ages 40 and older. While current guidelines recommend colorectal cancer screening starting at age 45, guideline groups may consider lowering the screening age in the future, according to Exact Sciences
Will Insurance Cover Cologuard Plus?
Doctors generally order Cologuard tests, and the test kit is sent to the patient's home. The original Cologuard costs $600 or more out of pocket, while FIT is around $20 to $40 and available over the counter.
Medicare coverage for Cologuard Plus has already been granted, according to the company, but not all other insurances cover it yet. The original Cologuard remains available while Exact Sciences works with health insurers on getting coverage for the new version.
Most insurance plans cover colorectal cancer screening with no co-pay under the Affordable Care Act.
When Should You Choose Cologuard Plus?
Colorectal cancer screening is essential for early detection and prevention. Though screening rates among adults under age 50 have increased in recent years, they're still low: A study found that only 33.7% of people age 45 to 49 got screened in 2023.
The U.S. Preventive Services Task Force recommends several screening options: a colonoscopy every 10 years, sigmoidoscopy or virtual colonoscopy every 5 years, a Cologuard test every three years, or a fecal immunochemical test (FIT) or fecal occult blood test (FOBT) every year. Each method has its benefits and drawbacks.
A colonoscopy, considered the gold standard, requires a liquid diet the day before to empty the bowel. Patients must take time off work and arrange for someone to pick them up due to sedation. However, this method allows providers to detect and remove precancerous polyps during the procedure, making it both a screening and preventive tool.
For those who prefer a noninvasive option, stool-based tests like Cologuard and FIT offer at-home alternatives. However, if the test results come back positive, a colonoscopy is still necessary to reduce cancer risk.
“The best colorectal screening test for someone is the one that they will do,” said Aaron Tokayer, MD, a gastroenterologist at Maimonides Medical Center in Brooklyn, New York.
