Cologuard is a noninvasive and stool DNA colorectal cancer screening test, which analyses both stool DNA and blood biomarkers.
It is developed to detect biomarkers from DNA in cancer, which is shed from the colon as part of the digestive process and blood released in the stool.
According to the company, Cologuard can detect 92% of cancers and 69% of the most advanced precancerous polyps in average risk patients.
After securing FDA approval, Exact Sciences also received a proposed coverage memorandum for Cologuard from the Centers for Medicare and Medicaid Services (CMS).
The company noted that Cologuard is the first product to take part in the joint FDA and CMS parallel review pilot program.
Both the agencies simultaneously review medical devices to help reduce the time between FDA approval and Medicare coverage.
Available through healthcare providers, Cologuard offers people aged 50 and older at average risk for colorectal cancer to test cancer at their home, the company said.
After a public comment period, a final National Coverage Determination is expected to be presented in October or November of this year.
Exact Sciences president, CEO and chairman Kevin Conroy said the FDA approval of Cologuard represents a major achievement in firm’s mission to make a noninvasive, patient-friendly screening test for colorectal cancer available.
"Cologuard addresses a critical need for a more convenient screening option for patients to aid in prevention and early detection," Conroy added.
Image: Cologuard analyzes both DNA alterations and blood in the stool to detect the presence of colon cancer and precancers. Photo: courtesy of Exact Sciences.
