Exact Sciences, in collaboration with Mayo Clinic, it has initiated the Voyage study to generate evidence of the real-world impact of Cologuard on colorectal cancer screening, incidence, and mortality rates. Voyage is a prospective, observational study designed to enrol more than 150,000 people with a valid Cologuard order and follow them for at least seven years to evaluate clinical outcomes. Voyage is one of the largest prospective, observational colorectal cancer screening studies ever conducted.
More than 50,000 Americans die from colorectal cancer each year, making it the second-leading cancer-killer in the US. Screening can save lives by preventing the disease or detecting it early however, more than an estimated 40 percent of the 106 million eligible Americans are not up-to-date with the American Cancer Society's colorectal cancer screening guidelines. Cologuard, which is according to the company the only FDA-approved, at-home colorectal cancer screening test, has the potential to help improve screening rates in this population.
According to the company, Cologuard is 92 percent sensitive for colorectal cancer, 69 percent sensitive for high-risk pre-cancer, and backed by a nationwide user-navigation system, providing 24/7 support to improve compliance with screening. Over the past five years, Cologuard has helped screen more than three million people for colorectal cancer, with nearly half of surveyed users reporting never being screened previously. Cologuard is widely accessible with 95 percent of users paying nothing out of pocket for the test.
"We applaud efforts to gather evidence on the performance and outcomes of colorectal cancer screening," said Dr Paul Limburg, Exact Sciences chief medical officer. "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 performance was initially validated in a 10,000 patient, prospective trial published in The New England Journal of Medicine in 2014. Voyage will provide additional, real-world evidence to demonstrate the clinical impact of Cologuard and help position it as standard-of-care in colorectal cancer screening.