FDA expands approval for Cologuard to 45-49 age range — 4 insights

The FDA expanded its approval for Exact Sciences' Cologuard to include the 45- to 49-year-old age range.

What you should know:

1. The expansion comes at a time when early-onset colorectal cancer rates continue to rise in the U.S.

2. Between 2004 and 2015, providers diagnosed more than 130,000 cases of early-onset CRC.

3. The American Cancer Society updated its guidelines in May 2018 to recommend Americans begin CRC screenings when they turn 45. To date, they are the only major U.S. organization to do so.

4. The extension expands Exact's potential patient base by approximately 19 million.

"With the FDA now approving the use of Cologuard for this vulnerable 45-49 age group, we are giving health care providers a sensitive, noninvasive option that has the potential to help combat the rise of colorectal cancer rates among this younger group of people," said Exact CEO Kevin Conroy.

Note: Becker's will have expanded commentary on the approval later this week.

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