FDA Approves First Noninvasive Colorectal Cancer Test

Exact Sciences has won FDA approval for the first noninvasive DNA screening test for colorectal cancer—the first stool-based diagnostic designed to indicate the presence of abnormal growths in red blood cells and DNA mutations, and the first test to be approved under a joint parallel review pilot program by the agency and the Centers for Medicare and Medicaid Services (CMS).

Cologuard® is designed to analyze both stool DNA and blood biomarkers, and is intended for at-home use by adults 50 years old and older. The test has been proven to find 92% of cancers and 69% of the most advanced precancerous polyps in average risk patients, according to Exact Sciences.

Upon FDA approval, Exact Sciences also received a proposed coverage memorandum from CMS under the pilot program, designed to help reduce the time between FDA approval and Medicare coverage by as many as six months. A final National Coverage Determination is expected to be posted in October or November of this year, following a public comment period.

Priced at $599, Cologuard is designed to detect biomarkers from cancer DNA that is shed from the colon as part of the digestive process and blood released in the stool. Through their physician, patients order a Cologuard kit mailed directly to their home. Patients then collect a stool sample via the Cologuard Collection Kit, then send the kit back to the Exact Sciences lab for testing through a pre–paid mailer.

The stool sample is analyzed in an automated system to yield a single test result—positive or negative for the presence of precancerous polyps or cancer. Results from the Cologuard test are turned around in about two weeks, with patients learning their results directly from their physician. Patients with positive test results are advised to undergo a diagnostic colonoscopy.

Cologuard does not require medication or dietary restrictions, or bowel preparation prior to taking the test.

“The test is designed for high accuracy, ease of patient use, and wide accessibility. We hope that it will make a difference and save many lives,” David Ahlquist, M.D., a Mayo Clinic gastroenterologist and co-inventor of the test, said in a statement.

Exact Sciences licenses the Cologuard technology from Mayo Clinic. Under that licensing agreement, Mayo and Dr. Ahlquist share in equity and royalties. Revenue received by Mayo Clinic is used to support its not–for–profit mission in patient care, education and research, the company said.

FDA said its approval of Cologuard does not change current practice guidelines for colorectal cancer screening. Stool DNA testing has yet to be recommended as a screening method for colorectal cancer by the U.S. Preventive Services Task Force (USPSTF). The task force still recommends that adults age 50 to 75, at average risk for colon cancer, be screened using fecal occult blood testing, sigmoidoscopy, or colonoscopy.

According to FDA, Cologuard’s safety and effectiveness were established through the Phase III DeeP–C Study, in which 10,023 subjects were screened. The clinical trial compared the performance of Cologuard to the commonly-used non-invasive fecal immunochemical test (FIT). Cologuard detected 92% of colorectal cancers and 42% of advanced adenomas in the study population, compared with 74% and 24%, respectively, through FIT screening. However, Cologuard gave an accurate negative screening for colorectal cancer or advanced adenomas less often — 87% of study subjects, versus 95% via FIT.

Results from DeeP–C were published in April in the New England Journal of Medicine.

“Cologuard addresses a critical need for a more convenient screening option for patients to aid in prevention and early detection,” stated Kevin Conroy, the president, CEO and chairman of Exact Sciences. “Exact Sciences is committed to making Cologuard available and accessible to patients and looks forward to advancing cancer detection in other gastrointestinal cancers.”

CMS has proposed coverage for the Cologuard test once every three years for Medicare beneficiaries who are 50 to 85 years old; at average risk of developing colorectal cancer; and show no signs or symptoms of colorectal disease including but not limited to lower gastrointestinal pain, blood in stool, positive guaiac fecal occult blood test or fecal immunochemical test.

Exact Sciences said it plans to make Cologuard available in select countries in Europe pending CE Mark.