The FDA has approved an upgraded version of Exact Sciences’ Cologuard test, the Madison-based diagnostics and screening company announced.
Kevin Conroy, chairman and CEO of Exact Sciences, says the Cologuard Plus test “sets a new performance standard” for non-invasive colorectal cancer screening.
“Cologuard Plus detects cancers and precancerous polyps with even greater sensitivity than Cologuard while reducing false positives by more than 30 percent,” Conroy said Friday in a statement. “This breakthrough comes at a critical time, when 60 million Americans are not up to date with screening.”
The federal agency’s approval was based on results of the BLUE-C study, which had almost 19,000 average-risk participants. It found the Cologuard Plus test “significantly outperformed” an independent fecal immunochemical test on a number of measures, the release shows.
Cologuard Plus, which was developed in partnership with Mayo Clinic, is now approved for adults aged 45 years or older that are at average risk for developing colorectal cancer, according to the announcement. The company says it plans to launch the test with Medicare coverage and U.S. Preventive Services Taskforce guideline inclusion next year.
Dr. Thomas Imperiale, professor of medicine at the Indiana University School of Medicine, is the principal investigator for the BLUE-C study. He says he’s confident the test will help improve the outlook for patients with colorectal cancer, also noting its low risk for false positive results.
“To meaningfully improve outcomes in colorectal cancer, we must catch cancer early – when it is most treatable — and find advanced precancers, which can prevent cases of this cancer,” he said, calling Cologuard Plus a “strong option for first-line screening of average risk patients.”
The original Cologuard test has been used more than 17 million times since being approved by the FDA in 2014, and Exact Sciences says it has “helped meaningfully improve” national colorectal cancer screening rates.
See more in the release.
