Mayo Clinic in Rochester, Minn., won a Eureka! Award for Cologuard, a noninvasive colorectal cancer screening and detection tool, according to a Minneapolis/St. Paul Business Journal report. Here are five things to know about Cologuard and its potential role in colorectal cancer screening.
1. David Ahlquist, MD, a Mayo Clinic gastroenterologist, is the co-inventor of Cologuard, a stool-based DNA colorectal cancer screening test. The test was developed through Exact Sciences, a health sciences firm, which has a collaboration and license agreement with Mayo Clinic.
2. The FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee unanimously voted to approve Cologuard. The FDA is not obligated to follow the advisory committee's recommendation, but will consider its guidance as Cologuard is evaluated. Exact Sciences continues to work towards achieving FDA approval and expects to receive a ruling this summer. Medicare is conducting a parallel review.
3. Exact Sciences conducted a clinical study published in the New England Journal of Medicine comparing the efficacy of Cologuard to the fecal immunochemical test. The study found that Cologuard detected 92 percent of colorectal cancer, compared to FIT's 74 percent detection rate. The study also demonstrated that Cologuard had a 42 percent sensitivity level in patients with advanced precancerous lesions, while FIT demonstrated 24 percent sensitivity
4. The Eureka! Awards, launched last year, are designed to recognize innovation in business, education, healthcare, the arts and more, according to a Milwaukee Business Journal report. "One of Mayo Clinic's hallmarks is its continual pursuit of innovations in the healthcare field. The invention of an at-home, noninvasive test to prescreen for colon cancer is not only innovative, it's an actual life saver," said awards judge Lindsay Sokolowski, in the Minneapolis/St. Paul Business Journal report.
5. Colonoscopy has long been considered the gold standard of colorectal cancer screening. "This test has some disruptive elements when it comes to cancer screening. We hope it will be seen as patient-friendly, with no prep, diet or medication restrictions. It's a noninvasive test that could have a significant impact on the screening and prevention numbers," said Dr. Ahlquist, in the Minneapolis/St. Paul Business Journal report. If approved, Cologuard could be another valuable tool in gastroenterologists' arsenal of tools for colorectal cancer prevention.
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