New noninvasive DNA colorectal cancer test co-invented by Mayo and Exact Sciences approved by U.S. Food and Drug Administration (FDA)

September 30, 2014

The U.S. Food and Drug Administration (FDA) has approved the first multimarker, stool-based colorectal cancer screening test, which was co-developed by Mayo Clinic. The test is designed to detect altered DNA and blood released from cancer and precancerous lesions of the colon. It is the first FDA-approved noninvasive DNA based screening test for colorectal cancer. The test was co-invented by Mayo Clinic and Exact Sciences as part of a license agreement through Mayo Clinic Ventures. The goal of the test is to encourage more patients to get screened for colon cancer — a critical step in preventing this prevalent disease. This test is a noninvasive way to identify colorectal cancer at its most treatable stage. It has been shown to be highly sensitive, able to detect 92 percent of colorectal cancer. Initially, the test will only be available on the Rochester campus. Plans are being made for rolling the test out to all Mayo Clinic locations. Patients will need a prescription from their provider.  Information about the exact date the test will be available will be shared as soon as it is available. This new stool DNA screening test is for people 50 years and older, asymptomatic and at average risk for colorectal cancer. The test is easy to use; patients can do in the privacy of their own home. It does not require medication or dietary restrictions prior to taking the test and requires no bowel preparation. If the test is positive, patients will need to undergo colonoscopy. Patients will need a prescription from their primary care provider.