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FDA Expands Indication for CRC Screening Test to Include Younger Patients

Lisa Astor
Published Online:9:57 PM, Mon September 23, 2019
Paul J. Limburg, MD, MPH, AGAF
Paul J. Limburg, MD, MPH, AGAF
The FDA has expanded the indication for the Cologuard noninvasive screening test for colorectal cancer (CRC) to include eligible patients with an average risk of developing CRC who are between the ages of 45 and 49.1

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

This expanded indication, now covering patients who are 45 years old and older, is reflective of the increasing incidence of early-onset CRC in the United States for patients under the age of 50. More than 130,000 cases of CRC in patients under the age of 50 were diagnosed in the United States between 2004 and 2015, with many of these patients diagnosed at advanced stages of disease.2

The company has also created a nationwide user-navigation system to support patients in their efforts to collect and return samples, in the hopes of increasing screening for CRC.

"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 J. Limburg, MD, MPH, AGAF, chief medical officer of Exact Sciences and a Mayo Clinic gastroenterologist, said in a statement. "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."

The stool DNA test was first approved by the FDA in August 2014 and became the first approved noninvasive screening test for CRC.3 The test is offered as a sensitive, at-home, stool-based screening option; it analyzes 10 DNA markers and hemoglobin in the patient’s stool sample.

The test was able to identify 92.3% of tumors and 69.2% of the most advanced precancerous polyps in average-risk patients in a pivotal study comparing the Cologuard test with a fecal immunohistochemical test in 9989 participants.4
  1. Cologuard Gains FDA Approval For Use In Younger Americans, Ages 45 To 49 [press release]. Exact Sciences Corp.: Madison, WI; September 23, 2019. https://bit.ly/2kwDsLx. Accessed September 23, 2019.
  2. Virostko J, Capasso A, Yankeelov TE, et al. Recent trends in the age at diagnosis of colorectal cancer in the US National Cancer Data Base, 2004-2015. Cancer. 2019;0:1-8. doi: 10.1002/cncr.32347.
  3. FDA approves exact sciences’ Cologuard; first and only stool DNA noninvasive colorectal cancer screening test [press release]. Exact Sciences Corp.: Madison, WI; August 12, 2014. https://bit.ly/2mEyhdk. Accessed September 23, 2019.
  4. 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.

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