NEW YORK – Exact Sciences and the Mayo Clinic announced today that they have initiated a study to analyze the real-world impact of the company's Cologuard colorectal cancer diagnostic test on colorectal cancer screening, incidence, and mortality rates.
The Voyage study is a prospective, observational study designed to enroll more than 150,000 people with a valid Cologuard order. The researchers will follow participants for at least seven years to evaluate clinical outcomes, Exact said.
"We applaud efforts to gather evidence on the performance and outcomes of colorectal cancer screening," Exact Chief Medical Officer Paul Limburg said in a statement. "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."
Cologuard's performance was initially validated in a 10,000-patient prospective trial, Exact noted.
In September, the company received approval from the US Food and Drug Administration to expand the indication for Cologuard to average-risk individuals aged 45 and older. The test had previously been indicated for people aged 50 and older.