Texas based Exact Sciences Corp. announced that the U.S. Food and Drug Administration (FDA) has approved Cologuard, the company’s noninvasive, stool DNA colorectal cancer screening test. Furthermore, it also received a proposed coverage memorandum from the Centers for Medicare and Medicaid Services (CMS), this way becoming the first product to take part in the joint FDA and CMS parallel review pilot program to help reduce the time between FDA approval and Medicare coverage.
Colorectal cancer is one of the most preventable cancers, however due to the invasive nature of current screening methods, there is a lack of patient compliance, with about 23 million Americans between 50 and 75 not getting screened as recommended by physicians. Colorectal cancer is the second leading cancer killer in the U.S., however if detected early, the five 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. 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 most treatable. Given that more than half of colorectal cancer–related deaths could be avoided with regular screenings, having Cologuard as another option for people who have resisted getting a colonoscopy could result in many lives being saved and screening compliance rates to increase.” Eric Hargis, CEO, Colon Cancer Alliance said in a company’s press release.
Cologuard is a non-invasive kit that allows for the analysis of stool DNA biomarkers shed from the colon through the digestive process, alongside biomarkers present in the blood that is released with the stool.
It has the capacity to detect 92% of cancers and 69% of the most advanced precancerous polyps in average risk patients, allowing people an easy–to–use screening test that can be preformed comfortably at home and does not involve painful methods or any medication, dietary restrictions and bowel preparation prior to taking the test.
Once Cologuard is performed, it can be mailed to the Exact Sciences lab, where it is analyzed in an automated system that gives a positive or negative result for the presence of precancerous polyps or cancer.
Exact Sciences’s DeeP–C Study evaluating Cologuard was one of the most extensive colorectal cancer screenings ever conducted in the US involving almost 10,000 participants.
The results entitled, “Multitarget Stool DNA Testing for Colorectal-Cancer Screening” were published in the New England Journal of Medicine and revealed that the sensitivity of DNA testing vs fecal immunochemical test (FIT) for detecting colorectal cancer, advanced precancerous lesions, polyps with high-grade dysplasia and serrated sessile polyps measuring 1 cm or more was 92.3% vs 73.8%, 42.4% vs 23.8%, 69.2% vs 46.2% and 42.4% vs 5.1%, respectively.
“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. 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 added in the press release.
“Cologuard addresses a critical need for a more convenient screening option for patients to aid in prevention and early detection. Exact Sciences is committed to making Cologuard available and accessible to patients and looks forward to advancing cancer detection in other gastrointestinal cancers” added Kevin Conroy, President, CEO and Chairman of Exact Sciences.