Exact Sciences to study Cologuard in real-world setting

15 October 2019 (Last Updated October 15th, 2019 12:19)

Molecular diagnostics firm Exact Sciences has collaborated with Mayo Clinic to study its colorectal cancer screening test Cologuard in a real-world setting.

Exact Sciences to study Cologuard in real-world setting
Cologuard is an FDA-approved, non-invasive, stool-based DNA colorectal cancer screening test. Credit: © Exact Sciences Corporation.

Molecular diagnostics firm Exact Sciences has collaborated with Mayo Clinic to study its colorectal cancer screening test Cologuard in a real-world setting.

The partners have initiated a prospective, observational study, Voyage, to assess Cologuard’s effect on colorectal cancer screening, incidence and mortality rates.

During the study, more than 150,000 participants with a valid Cologuard order will be followed for a minimum of seven years to determine clinical outcomes.

Cologuard, which received the US Food and Drug Administration (FDA) approval in 2014, is an at-home stool screening test to detect colorectal cancer.

Colorectal cancer is responsible for more than 50,000 deaths each year in the US. Screening can help prevent the disease or identify it in early stages.

Exact Sciences noted that Cologuard has 92% and 69% sensitivity for colorectal cancer and high-risk pre-cancer, respectively.

Over the past five years, more than three million people have been screened using the test, which comes with a user-navigation system to offer support and boost compliance.

The test was evaluated in a prospective trial involving 10,000 patients; the New England Journal of Medicine published the trial’s findings.

Voyage is intended to gather additional, real-world evidence on the clinical impact of the test.

Exact Sciences chief medical officer Paul Limburg said: “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.”

The Voyage study will track the use of health services and associated health outcomes in a cohort of average-risk adults prescribed Cologuard for routine colorectal cancer screening across the US.

Data from the study is expected to aid the adoption of Cologuard as standard-of-care in colorectal cancer screening.