FDA approves first DNA screening test for colorectal cancer

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CANCER DIGEST – Aug. 12, 2014 –The U.S. FDA today approved Cologuard, the first stool-based DNA colorectal screening test that detects genetic mutations that may indicate colon cancer or precursors to cancer.

Using a stool sample, Cologuard detects blood components and certain mutations associated with colorectal cancer in the DNA of cells shed by advanced adenomas as stool moves through the large intestine and rectum. Patients with positive test results are advised to undergo a diagnostic colonoscopy.

In a clinical trial involving 10,023 patients, Cologuard was compared to another stool-based test, called FIT (fecal immunochemical test). Cologuard detected 92 percent of colorectal cancers and 42 percent of advanced adenomas in the study population, while the FIT screening test detected 74 percent of cancers and 24 percent of advanced adenomas. Cologuard was less accurate than FIT at correctly identifying subjects negative for colorectal cancer or advanced adenomas.

Today’s approval of the Cologuard does not change current practice guidelines for colorectal cancer screening. Stool DNA testing (also called “fecal DNA testing”) is not currently recommended as a method to screen for colorectal cancer by the United States Preventive Services Task Force (USPSTF). Cologuard underwent parallel review by the FDA and the Centers for Medicare & Medicaid Services (CMS), a pilot program aimed at reducing the time between FDA approval and Medicare coverage. The CMS today proposes to cover the test once every three years for qualifying Medicare beneficiaries.

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