USPSTF Gives Grade B Recommendation for Lower CRC Screening Age, Lists Cologuard as a Suggested Screening Method

The United States Preventive Services Task Force now recommends that colorectal cancer screening begin 5 years earlier, at age 45 versus age 50, according to new draft guidelines.

The United States Preventive Services Task Force (USPSTF) now recommends that colorectal cancer (CRC) screening begin 5 years earlier, at age 45 versus age 50, according to new draft guidelines.1

The grade B recommendation, which endorses screening for CRC in adults aged 45 to 49 years, also lists the noninvasive CRC screening test Cologuard as a recommended screening method for all average-risk adults between the ages of 45 years and 75 years. CRC screening for adults aged 50 years to 75 years remains a grade A recommendation.2

“Exact Sciences commends the members of the USPSTF for lowering the screening age and recommending Cologuard among multiple screening test options,” said Kevin Conroy, chairman and CEO of Exact Sciences.2 “The confidence in and influence of the guidelines will without a doubt encourage more clinicians to offer screening to their patients starting at 45.”

In August 2014, Cologuard became the first FDA-approved stool DNA screening test for CRC, receiving inclusion in the USPSTF screening guidelines for those over the age of 50 years. The approval was based on findings from a 9989-patient clinical trial that demonstrated a 92.3% CRC-detection rate with Cologuard versus 73.8% with a fecal immunochemical test (FIT; P < .001). The specificities were 86.6% and 94.9% with DNA testing and FIT, respectively, among adults with nonadvanced or negative results (P < .001) and 89.8% and 96.4%, respectively, among those with negative colonoscopy results (P < .001).3

In September 2019, the FDA expanded the approval of Cologuard to include eligible at-risk adults 45 years of age or older.4 The expanded 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 years to 49 years.

Cologuard uses a biomarker panel to assess an individual stool sample for 10 DNA markers, such as aberrantly methylated BMP3 and NDRG4 promoter regions, KRAS mutations, β-actin, and hemoglobin.

Research presented at the 2020 American College of Gastroenterology (ACG) Annual Scientific Meeting indicated that cancer screening rates have risen since 2014, largely attributable to the approval and use of Cologuard.5

In the retrospective analysis, investigators evaluated CRC screening based on IBM MarketScan claims that had been made between August 2011 and July 2019. The study included 60,770 average-risk patients aged 50 years to 75 years who were enrolled in their health plan in the past decade.

Between 50% and 70% of these patients were up to date with screening, with increasing proportions each year. Among patients newly screened, multi-target stool DNA (Cologuard) uptake increased from 2% in 2016 to 15% in 2018.

“The draft updated USPSTF guidelines along with the data presented at ACG illuminate the fact that when patients are included in discussions around their choice of screening method, they are more likely to participate in colorectal cancer screening,” said Paul Limburg, MD, chief medical officer, Screening, at Exact Sciences. “We believe these draft guidelines will encourage clinicians to continue supporting patient choice and informed decision making.”


  1. Exact Sciences commends task force for draft updated guidelines that include colorectal cancer screening beginning at age 45. Exact Sciences Corp. October 27, 2020. Accessed October 30, 2020.
  2. Colorectal cancer screening. U.S. Preventive Services Task Force. October 27, 2020. Accessed October 30, 2020.
  3. Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297. doi:10.1056/NEJMoa1311194
  4. Cologuard gains FDA approval for use in younger Americans, ages 45 to 49. Exact Sciences. September 23, 2019. Accessed October 30, 2020.
  5. Fisher DA, Princic N, Miller-Wilson LA, et al. Colorectal cancer screening by test type prior to and following MT-SDNA market entry among average risk patients: a real world analysis. Presented at: 2020 ACG Virtual Meeting; October 23-28, 2020. Virtual. Abstract P0742 (S0299).