First Stool-Based Colon Cancer Screening Test Receives FDA Approval with Proposed Medicare Coverage

The FDA today approved Cologuard, the first non-invasive colorectal screening test to indicate the presence of certain abnormal growths that may be colorectal cancer or precursors to colon cancer.

Using a stool sample, Exact Sciences’ Cologuard detects hemoglobin, a protein molecule that is a component of blood, as well as 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.

“This approval offers patients and physicians another option to screen for colorectal cancer,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in an FDA statement. “Fecal blood testing is a well-established screening tool and the clinical data showed that the test detected more cancers than a commonly used fecal occult test.”

However, the FDA noted Cologuard’s approval does not change current practice guidelines, under which stool DNA testing is not currently recommended as a method to screen for colorectal cancer by the US Preventive Services Task Force (USPSTF). Among other guidelines, the USPSTF recommends that adults aged 50 to 75 years at average risk for colon cancer be screened using fecal occult blood testing, sigmoidoscopy, or colonoscopy.

Among cancers that affect both men and women, colorectal cancer is the third most common cancer and the second leading cause of cancer-related death in the United States, according to the US Centers for Disease Control and Prevention (CDC). Because screening is effective at reducing illness and death related to colon cancer, the CDC estimates that if all patients aged 50 years or older had regular screening tests as recommended, at least 60% of colorectal cancer deaths could be avoided.

The safety and effectiveness of Cologuard was established in a clinical trial that compared its performance to the fecal immunochemical test (FIT), a commonly used non-invasive screening test that detects blood in stool. In the study, Cologuard detected 92% of colorectal cancers and 42% of advanced adenomas, while the FIT screening test detected 74% of cancers and 24% of advanced adenomas.

However, Cologuard was less accurate at correctly identifying subjects negative for colorectal cancer or advanced adenomas, as it correctly gave a negative screening result for 87% of the study subjects, while FIT provided accurate negative screening results for 95% of the study population.

To help reduce the time between the screening test’s FDA approval and its Medicare coverage, the US Centers for Medicare & Medicaid Services (CMS) today issued a proposed national coverage determination for Cologuard, which is the first product to be reviewed through the joint FDA-CMS parallel review pilot program.

“This is the first time in history that FDA has approved a technology and CMS has proposed national coverage on the same day,” said Patrick Conway, chief medical officer and deputy administrator for innovation and quality for CMS. “This parallel review represents unprecedented collaboration between the 2 agencies and industry and most importantly will provide timely access for Medicare beneficiaries to an innovative screening test to help in the early detection of colorectal cancer.”

CMS has proposed to cover the Cologuard test once every 3 years for Medicare beneficiaries who are aged 50 to 85 years; have no signs or symptoms of colorectal disease; have no personal history of adenomatous polyps, colorectal cancer, or inflammatory bowel disease, including Crohn’s disease and ulcerative colitis; and have no family history of colorectal cancers or an adenomatous polyp, familial adenomatous polyposis, or hereditary nonpolyposis colorectal cancer.