Rochester, Minn.-based Mayo Clinic and Exact Sciences will begin a seven-year study to evaluate how Cologuard affects colorectal cancer screening, incidence and mortality rates.
What you should know:
1. Researchers will attempt to enroll more than 150,000 people with a valid Cologuard order into the study, known as Voyage. Researchers will follow the participants for seven years to evaluate outcomes.
2. Cologuard's FDA approval was based on a 10,000 patient trial, which was published in 2004. That trial confirmed Cologuard's 92 percent sensitivity rate for CRC and 69 percent sensitivity rate for high-risk precancer. The study also confirmed the test's 86.6 percent specificity among patients with non-advanced or negative findings and its 89.89 percent specificity among patients with negative colonoscopy results.
3. The Exact-initiated study follows a recent study published in Plos One that said Cologuard was less effective and more costly than other CMS-reimbursed screening strategies.
"We applaud efforts to gather evidence on the performance and outcomes of colorectal cancer screening," Paul Limburg, MD, Exact's chief medical officer, said in a 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."