Cologuard Plus: A New Upgrade in At-Home Colorectal Cancer Screening

Cologuard, a popular at-home colorectal cancer screening test, is getting an enhanced version called Cologuard Plus, set to be available in spring 2025. Designed for individuals aged 45 and older at average risk for colorectal cancer, this updated test is expected to provide greater accuracy and lower false positive rates compared to the original test, which was first approved in 2014.  

The Cologuard Plus process remains similar to the original: users collect a stool sample at home using a treated paper over the toilet. The sample is securely stored in a container provided by the test kit and sent back to Exact Sciences, the test manufacturer, using a prepaid label.  

How Does Cologuard Plus Compare to the Original?  

The Food and Drug Administration (FDA) approved Cologuard Plus after a 2024 trial involving 20,000 participants. The study compared Cologuard Plus to the fecal immunochemical test (FIT), another stool-based test that screens for early signs of colon cancer by detecting hidden blood. While FIT screens for blood alone, Cologuard tests for both blood and genetic abnormalities.  

Trial participants also underwent colonoscopies to confirm the test results. Cologuard Plus detected 94% of colorectal cancers, outperforming FIT, which detected 67%. Moreover, Cologuard Plus correctly identified individuals without cancer or advanced precancerous polyps 93% of the time, compared to FIT's 96% accuracy in this area.  

Exact Sciences spokespersons note that although the trial did not directly compare the original Cologuard to Cologuard Plus, the newer version offers a key improvement: an extended time frame for returning samples. Cologuard samples must be shipped within four days, while Cologuard Plus samples have a six-day window due to upgraded preservatives.  

According to Exact Sciences, Cologuard Plus may be up to 30% more accurate than its predecessor, with a lower false positive rate. The false positive rate for the original Cologuard was 13%, meaning reducing these occurrences could ease concerns and increase participation rates, said Michael Sapienza, CEO of the Colorectal Cancer Alliance.  

“The recommendations 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,” Sapienza said. “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 participants aged 40 and older. While current guidelines begin colorectal cancer screening at age 45, some groups may reevaluate this threshold in the future, according to Exact Sciences.  

Cost and Insurance for Cologuard Plus  

Cologuard tests are typically ordered by doctors and shipped directly to the patient’s home. Currently, the original test costs $600 or more if paid out of pocket, while FIT costs $20 to $40 and can be purchased over the counter.  

Cologuard Plus will be available by the end of June 2025, alongside the original version, while Exact Sciences works with insurers to secure coverage. Medicare has already approved coverage for Cologuard Plus, and most insurance plans are expected to cover colorectal cancer screening tests with no co-pay, thanks to the Affordable Care Act.  

However, this coverage could be affected by a pending lawsuit challenging the U.S. Preventive Services Task Force’s authority over screening recommendations. If the lawsuit succeeds, it could eliminate insurance coverage for many preventive tests, including colon cancer screenings.  

Choosing the Right Screening Method  

Early detection of colorectal cancer is critical, yet screening rates among adults under 50 remain low. According to the American Cancer Society, only 2.4% of newly eligible adults aged 45 to 49 used a stool-based test in 2021, while approximately 18% opted for a colonoscopy.  

The U.S. Preventive Services Task Force recommends several screening options: a colonoscopy every 10 years, a Cologuard test every three years, or an annual FIT. Each of these methods has its benefits and drawbacks.  

A colonoscopy—the gold standard for colorectal cancer screening—allows doctors to directly detect and remove precancerous polyps during the procedure, making it both diagnostic and preventive. However, preparation requires a liquid diet the day before, as well as sedation, meaning patients must arrange transportation and time off work.  

Noninvasive stool-based tests like Cologuard Plus and FIT provide convenient at-home alternatives. However, individuals who test positive will still require a follow-up colonoscopy to confirm or rule out cancer.  

“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.  

With the introduction of Cologuard Plus, patients now have access to a more sensitive screening tool that may increase the likelihood of detecting cancers early while reducing false positives—all with the convenience of at-home testing.