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FDA Approves CRC Screening Test for Younger, At-Risk Individuals

Gina Columbus @ginacolumbusonc
Published: Monday, Sep 23, 2019

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 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.


  1. Cologuard Gains FDA Approval For Use In Younger Americans, Ages 45 To 49. Exact Sciences. Published September 23, 2019. Accessed September 23, 2019.
  2. 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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