Routine Annual Screening for Colorectal Cancer Not Achieved by Fecal Blood Tests

PR Newswire

MADISON, Wis., Feb. 19, 2016 /PRNewswire/ -- Only three in a thousand people (0.3 percent) were adherent with annual colorectal cancer screening using either the fecal immunochemical test (FIT) or fecal occult blood test (FOBT) during a continuous 10-year observation period, according to the results of a more than 150,000-subject study recently published in the American Journal of Managed Care.

Annual FOBT testing has been included in the United States Preventive Services Task Force (USPSTF) guidelines since colon cancer screening was first recommended, with FIT added in 2008. These new data demonstrate that annual adherence to screening with fecal blood tests is difficult. Of the patients who use fecal blood tests for screening, average utilization was only one test every four years.

"This study highlights the fallacy of annual fecal blood testing as an effective means of colon cancer screening," said Kevin Conroy, chairman and CEO of Exact Sciences. "The USPSTF assumed 100 percent fecal blood test adherence in its effectiveness modeling, when in fact virtually no patients are adherent. These data question the assumptions on the clinical use of fecal blood tests. A colon cancer screening option like Cologuard, which is supported by a patient-focused compliance service, can increase screening effectiveness by helping to ensure high levels of adherence.

"Cologuard demonstrated significantly higher sensitivity than FIT in a 10,000-patient prospective study and is the only screening test backed by a nationwide colon cancer compliance service," Conroy said. "More than 150 members of the Exact Sciences customer care team are directly engaging patients to ensure they complete a Cologuard test once it's prescribed by a physician. Our team has maintained a compliance rate above 70 percent while also removing the burden of patient compliance from physicians." The Cologuard compliance rate is derived from the number of valid Cologuard test results generated from collection kits shipped to patients during the past 60 days or more.

The study was commissioned by Exact Sciences and conducted by Optum, a division of UnitedHealth Group, to investigate longitudinal adherence during a 10-year period to the USPSTF colorectal cancer screening recommendations. It included 151,638 subjects at average risk for colorectal cancer who reached the age of 50 between Jan. 1, 2000, and Dec. 31, 2004. Data were collected and analyzed retrospectively from patient claims from a large, national database.

The study is available online from the American Journal of Managed Care.

About Cologuard

Cologuard was approved by the FDA in August 2014 and results from Exact Sciences' prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society and stool DNA is listed in the screening guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer.

Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard, visit www.CologuardTest.com. Rx Only.

About Exact Sciences Corp.

Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society and stool DNA is included in the U.S. Multi-Society Task Force on Colorectal Cancer. For more information, please follow us on Twitter @ExactSciences or find us on Facebook.

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CONTACT: JP Fielder, [email protected], 608-210-5220