Cologuard Gets FDA Approval to Expand CRC Screening Test to Younger Individuals


Popular noninvasive colorectal cancer screening test, Cologuard, recently received permission from the FDA to expand its test.

The FDA has expanded the approval of the noninvasive colorectal cancer (CRC) screening test Cologuard to include eligible at-risk individuals ≥45 years.1

The updated indication of the at-home stool-based screening assay applies to approximately 19 million average-risk individuals in the United States between the ages of 45 to 49. Cologuard was previously indicated for those ≥50 years.

"About 3 million people have been screened for colorectal cancer with Cologuard, with nearly half of those surveyed saying they were previously unscreened," Kevin Conroy, chairman, and CEO of Exact Sciences, the manufacturer of Cologuard, stated in a press release. "With the FDA now approving the use of Cologuard for this vulnerable 45 to 49 age group, we are giving health care providers a sensitive, noninvasive option that has the potential to help combat the rise of colorectal cancer rates among this younger group of people."

Cologuard uses a biomarker panel, which analyzes an individual stool sample for 10 DNA markers, such as aberrantly methylated BMP3 and NDRG4 promoter regions, KRAS mutations, and β-actin, as well as hemoglobin. Additionally, the company provides 24/7 phone and online support to assist individuals through the process of collecting and returning their samples.

Between 2004 and 2015, healthcare providers diagnosed more than 130,000 cases of CRC in Americans under the age of 50, the company stated in the press release.

Moreover, in May 2018, the American Cancer Society (ACS) updated its CRC screening guidelines to include people between the ages of 45 to 49; its prior ACS recommendation recommended screening at age 50.

"The medical and scientific communities agree that rising rates of colorectal cancer in younger adults must be addressed, and we support efforts to gather evidence on the impact of screening in younger populations," Paul Limburg, MD, MPH, AGAF, chief medical officer of Exact Sciences and gastroenterologist at Mayo Clinic, stated in the press release. "As research progresses, we must offer screening options to people that may already have or will develop colorectal cancer and pre-cancers, aiming to increase screening rates and halt the rise of colorectal cancer in younger Americans."

In August 2014, Cologuard was first approved by the FDA based on findings from a 9989-patient clinical trial that demonstrated that CRC was detected in 92.3% of patients versus 73.8% in those who were screened with Cologuard versus the fecal immunochemical test (FIT; P <.001).2 The polyp detection rate with high-grade dysplasia was 69.2% with the DNA test compared with 46.2% with FIT (P = .004). Additionally, the rates of detection of serrated sessile polyps ≥1 cm were 42.4% and 5.1%, respectively (P <.001). The specificities with DNA testing and FIT were 86.6% and 94.9%, respectively, among individuals with nonadvanced or negative results (P <.001) and 89.8% and 96.4%, respectively, among those who had negative results on colonoscopy (P <.001). The investigators did note that while the multitarget stool DNA test did detect significantly detect more cancers compared with FIT, it also was associated with more false-positive results.

Cologuard was reviewed through a joint FDA-Centers for Medicare and Medicaid Services (CMS) program that resulted in an already established coverage plan. Under this plan, CMS would cover the Cologuard test when administered once every 3 years for Medicare beneficiaries between the ages of 50 and 85 who do not demonstrate symptoms of CRC and are at average risk.

The assay is included in the ACS's 2018 CRC screening guidelines and is also recommended for those over the age of 50 by the United States Preventive Services Task Force and National Comprehensive Cancer Network.

A version of this article originally appeared on OncLive® as “FDA Approved CRC Screening Test for Younger, At-Risk Individuals”.


  • Cologuard Gains FDA Approval For Use In Younger Americans, Ages 45 To 49. Exact Sciences. Published September 23, 2019. Accessed September 23, 2019.
  • Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget Stool DNA Testing for Colorectal-Cancer Screening. N Engl J Med. 2014;370:1287-1297. doi: 10.1056/NEJMoa1311194.

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