FDA Approves First Noninvasive DNA Screening Test for Colorectal Cancer

Get Permission

The U.S. Food and Drug Administration (FDA) has approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer.

Using a stool sample, Cologuard detects hemoglobin 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.

Clinical Trial Results

The safety and effectiveness of Cologuard was established in a clinical trial that screened 10,023 subjects. The trial compared the performance of Cologuard to the fecal immunochemical test, a commonly used noninvasive screening test that detects blood in the stool. Cologuard accurately detected cancers and advanced adenomas more often than the fecal immunochemical test: 92% of colorectal cancers and 42% of advanced adenomas were detected with stool DNA testing compared with 74% of cancers and 24% of advanced adenomas detected with fecal immunochemical testing.

Cologuard was less accurate than fecal immunochemical testing at correctly identifying subjects negative for colorectal cancer or advanced adenomas. The stool DNA test correctly gave a negative screening result for 87% of the study subjects, while the fecal immunochemical test provided accurate negative screening results for 95% of the study population.

Proposed CMS Coverage

Upon the test’s approval, the Centers for Medicare & Medicaid Services (CMS) issued a proposed national coverage determination for Cologuard. Cologuard is the first product reviewed through a joint FDA-CMS pilot program known as parallel review, where the agencies concurrently review medical devices to help reduce the time between the FDA’s approval of a device and Medicare coverage.

“Parallel review allows the last part of the FDA process to run at the same time as the CMS process, cutting as many as 6 months from the time from study initiation to coverage,” said ­Nancy Stade, Deputy Director for Policy at the FDA’s Center for Devices and Radiological Health.

CMS proposes to cover the Cologuard test once every 3 years for Medicare beneficiaries who are age 50 to 85 years, asymptomatic, and have an average risk of developing colorectal cancer. ■