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FDA approves Exact Sciences' Cologuard test for younger Americans

MADISON, Wis. - Madison-based Exact Sciences says their at-home colorectal cancer kit Cologuard is being approved by the FDA for use in adults aged 45 and up.

Previously, the test was only approved for people 50 and older.

Exact Sciences says by dropping the approved age to 45, the test becomes available for about 19 million more people. The company says nearly 3 million people have used Cologuard to test for colorectal cancer at home.

Numbers from the American Cancer Society show more than 130,000 cases of colorectal cancer were diagnosed in people between the ages of 45 and 50 between 2004 and 2015. Because of that, the ACS updated its colorectal cancer screening guidelines in May 2018 to include people between the ages of 45 and 49.

"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," Exact Sciences Chief Medical Officer Paul Limburg, MD, MPH, AGAF said in a 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."

The FDA approval brings the Cologuard test in alignment with that recommendation.

Colorectal cancer is the second-deadliest cancer in the United States.

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