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FDA Approves Cologuard for Persons Aged 45 and Older at Average Risk for Colorectal Cancer


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Today, the U.S. Food and Drug Administration (FDA) approved the noninvasive colorectal cancer screening test Cologuard for eligible average-risk individuals aged 45 years and older, expanding on its previous indication for those aged 50 years and older.

Cologuard is a stool DNA-based colorectal cancer screening test for average-risk individuals. It uses a biomarker panel that analyzes a stool sample for 10 DNA markers, as well as blood in the stool.

Growing Incidence of Younger-Onset Colorectal Cancer

The decision comes at a critical time when the incidence of colorectal cancer is on the rise among American adults younger than age 50. According to a report by Wolf et al published in CA: A Cancer Journal for Clinicians, between 2004 and 2015, health-care providers diagnosed more than 130,000 cases of colorectal cancer in Americans younger than age 50. Among these cases, more than half were diagnosed at an advanced stage.

The American Cancer Society (ACS) responded to the growing trend of colorectal cancer in younger patients in May 2018 when it updated its colorectal cancer screening guidelines to include people between the ages of 45 to 49. The prior ACS recommendation called for screening to begin at age 50.

Cologuard Navigation System

In an effort to combat the colorectal cancer screening gap, Exact Sciences, the manufacturer of Cologuard, has designed a nationwide use navigation system, which provides 24/7 phone and online support to help people through the process of collecting and returning their samples. This approach combines multiple industry best practices to offer a vital tool in the collective efforts to increase colorectal cancer screening.

“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,” said Paul Limburg, MD, MPH, AGAF, Chief Medical Officer of Exact Sciences and a gastroenterologist at the Mayo Clinic. “As research progresses, we must offer screening options to people who may already have or will develop colorectal cancer and precancers, aiming to increase screening rates and halt the rise of colorectal cancer in younger Americans.”

Cologuard is available to appropriate patients through their health-care provider. For more information, visit www.CologuardTest.com.


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