FDA has granted premarket approval to Cologuard by Exact Sciences, Madison, Wis, the first noninvasive screening test for colorectal cancer that analyzes both stool DNA and blood biomarkers.
Cologuard has been shown to detect 92% of cancers and 69% of the most advanced precancerous polyps in average-risk patients. Available through healthcare providers, the test offers people 50 and older at average risk for colorectal cancer an easy-to-use screening test they can do in the privacy of their own home.
Upon FDA approval, Exact Sciences also received a proposed coverage memorandum from the Centers for Medicare & Medicaid Services (CMS). Cologuard is the first product to take part in the joint FDA and CMS parallel review pilot program in which both agencies simultaneously review medical devices to help reduce the time between FDA approval and Medicare coverage. A final National Coverage Determination is expected to be posted in October/November of this year, after a public comment period.
Because of patient resistance to screening involving colonoscopy, colorectal cancer is considered the most preventable yet least prevented cancer. An estimated 23 million Americans between 50 and 75 are not getting screened as recommended and, as a result, colorectal cancer remains the second-leading cancer killer in the US. For those whose cancer is detected at an earlier stage, the 5-year survival rate can be greater than 90%.
“Colorectal cancer is highly preventable, and following the recommended screening guidelines can lead to life-saving early detection,” says Eric Hargis, CEO of the Colon Cancer Alliance. “In more than 60% 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 most treatable.
Given that more than half of colorectal cancer-related deaths could be avoided with regular screenings,” Hargis adds, “having Cologuard as another option for people who have resisted getting a colonoscopy could result in many lives being saved and screening compliance rates increasing.”
Cologuard is designed to detect biomarkers from DNA in cancer that is shed from the colon as part of the digestive process, and in blood released in the stool. After the physician orders Cologuard, the kit is mailed directly to the patient’s home. The patient then collects a stool sample in the Cologuard collection kit, and uses a prepaid mailer to send the kit back to the Exact Sciences lab for testing.
At the lab, 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 as little as two weeks, and patients learn their results directly from their prescribing physician. Unlike many other screening options, Cologuard does not require medication, dietary restrictions, or bowel preparation prior to taking the test.
“The robustly conducted research as part of this FDA approval process has proven that this noninvasive test is highly sensitive in detecting both early-stage colorectal cancer and the most advanced precancerous polyps most likely to develop into cancer,” says David Ahlquist, MD, a Mayo Clinic gastroenterologist and coinventor of 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.”
“FDA approval of Cologuard represents a major achievement in Exact Sciences’ mission to make a noninvasive, patient-friendly screening test for colorectal cancer available,” says Kevin Conroy, chairman, president, and CEO of Exact Sciences. “Cologuard addresses a critical need for a more convenient screening option for patients to aid in prevention and early detection.”
Further information about FDA’s approval of Cologuard, including the agency’s approval letter and the product’s summary of safety and effectiveness data, is available via the FDA website.
Cologuard is available to US patients through their healthcare providers. Pending receipt of a CE mark for the product, Exact Sciences also has plans to make Cologuard available in select countries in Europe. For more information, visit Exact Sciences.