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.”
More articles on surgery centers:
27 states gained Medicare-certified ASCs from 2017-18
Average salary for 5 key physician specialties
The 6 most common cases migrating to outpatient venues
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.