FDA approves DNA screening test for colorectal cancer

The CDC estimates that if all Americans were screened at the age of 50 we could cut colon cancer deaths by 60%. This week a new tool was added to the screening toolbox. On Monday, August 11, the U.S. Food and Drug Administration approved Cologuard, the first stool-based colorectal cancer screening test to detect DNA mutations that may indicate the presence of colon cancer.

Adding Cologuard to approved tests for colon cancer gives patients an additional screening option. Cologuard detects hemoglobin (proteins in blood) in a stool sample. It can also detect certain DNA mutations in cells shed by advanced adenomas as stool moves through the large intestine and rectum. Following a positive Coloplast test result, patients will be advised to undergo a diagnostic colonoscopy.

At the same time, the Centers for Medicare & Medicaid Services also issued a proposal that Cologuard be covered once every three years for Medicaid beneficiaries who meet the following criteria:

• Age 50 to 85 years,
• Asymptomatic
• Average risk for developing colon cancer.

Adding Cologuard to the FDA approval list and allowing it to be covered under Medicaid gives patients one more way to be screened and to reach the national goal of 80% screening rates by 2018.

Read the FDA’s complete press release here.