People may be able to screen for colorectal cancer using an in-home, noninvasive test.
The Cologuard test, produced by Exact Sciences Corp., analyzes stool DNA and blood biomarkers. It has a 92 percent accuracy rate for colorectal cancer and a 69 percent accuracy rate for advanced precancer polyps.
This test is also the first test to be part of a joint FDA and Centers for Medicare and Medicaid Services (CMS) review pilot program. This means along with FDA approval, it also received a proposed coverage memorandum from CMS. This reduces the difference between FDA approval and CMS coverage.
"Colorectal cancer is highly preventable and following the recommended screening guidelines can lead to life-saving early detection," said Eric Hargis, CEO of the Colon Cancer Alliance. "In more than 60 percent of all cases, colorectal cancer is not detected until its late stages, making treatment more challenging. New, patient-friendly screening options are desperately needed to prevent colorectal cancer or help identify it early, when it is more treatable."
Colorectal cancer is preventable but often not prevented as a result of patient non-compliance. For people whose cancer is detected at an earlier stage, the survival rate is more than 90 percent.
The test detects biomarkers in stool and blood released from the colon as part of the digestive system. It detects DNA from the cancer in the colon.
The test is ordered by the physician and then sent to the patient's home. Then the patient collects the sample and sends it back to Exact Sciences for laboratory testing.
"The test is designed for high accuracy, ease of patient use, and wide accessibility," said Dr. David Ahlquist, co-inventor of the test. "We hope that it will make a difference and save many lives."
The stool sample is analyzed and yields either a positive or negative test result. The test results can be turned around in as little as two weeks. Additionally, since it is noninvasive it may be more amenable to patients who do not want to go through the process of getting a colonoscopy.
The results of the study were published in The New England Journal of Medicine. The cost of the test is $599 through healthcare providers.
