recommend providers offer patients the opportunity to select either a structural (visual) examination or a high-sensitivity stool test in order to increase adherence.”
Exact completed about 571,000 tests of Cologuard last year, and projects it will complete at least 900,000 of the tests this year. The company’s long-term goal is to screen at least 8 million patients with Cologuard annually, as Conroy told Xconomy earlier this month.
Cologuard is currently approved for screening patients ages 50 to 84. Exact said Wednesday that it plans to seek regulatory approval to expand that age range.
“With more than 20 million Americans age 45-49, Exact Sciences affirmed its commitment to seek FDA approval for making Cologuard … available to those in this population who are at average risk for colorectal cancer,” according to the news release.
Exact did not give a target date for getting FDA approval for using Cologuard to screen 45- to 49-year-olds. However, a company spokesperson said “the overall process (study to approval) is usually measured in years,” rather than months.
