15 Oct WisBusiness: Exact Sciences is partnering with the Mayo Clinic on a new study to analyze the impact of Cologuard over a seven-year period
The Voyage study will enroll more than 150,000 people that order the Cologuard colon cancer test and track them for seven years, gathering data on clinical outcomes for this population. A release shows the study is one of the largest of its kind ever conducted.
Colon cancer is the second-most deadly cancer in the country, with more than 50,000 associated deaths in the United States each year. Although the prognosis for early diagnosis is much better, just 40 percent of the 106 million eligible U.S. adults adhere to colon cancer screening guidelines from the American Cancer Society, according to the release.
“This study will be instrumental in further demonstrating the clinical utility of Cologuard, a highly accurate, non-invasive screening option, in our collective effort to reduce the colorectal cancer burden,” said Paul Limburg, chief medical officer for the Madison-based company.
The latest results from Exact Sciences show that Cologuard is 92 percent sensitive for colon cancer and 69 percent sensitive for “high-risk pre-cancer.” It’s been used to screen more than three million people for colon cancer, and the company claims 95 percent of users don’t have to pay out of pocket for the test.
An earlier study published in the New England Journal of Medicine in 2014 provided initial validation for the Cologuard test with trial results from 10,000 patients. The Voyage study is expected to deliver more information about the impact of Cologuard on the patients that use it.