Cologuard test included in final USPSTF Colorectal Cancer screening recommendations

June 15, 2016 – MADISON. Exact Sciences Corp. announced that the U.S. Preventive Services Task Force (USPSTF) issued its final 2016 colorectal cancer screening recommendations and clarified the inclusion of Cologuard® (FIT-DNA) on equal standing among the other included screening tests.

“We believe the final recommendations provide an important level of clarity to patients, physicians and insurers and that Cologuard should receive the benefits given to A-rated preventive services under the Affordable Care Act,” said Kevin Conroy, Exact Sciences’ chairman and CEO.  “We thank the Task Force for carefully reviewing the body of scientific evidence supporting Cologuard and for providing this clear guidance.”

The USPSTF clarified the standing of Cologuard in its final Recommendation Statement, published in the Journal of the American Medical Association today, after reviewing additional scientific literature and public comments about its Oct. 5, 2015 draft guidelines.  The final recommendations state, “Many comments expressed concern that the terms ‘recommended’ and ‘alternative’ to describe the testing strategies lacked clarity and were confusing to interpret.  In response, the USPSTF removed these terms from the final recommendation to better communicate the primary message of importance: there is convincing evidence that screening for colorectal cancer provides substantial benefit for adults aged 50 to 75 years, and a sizable proportion of the eligible US population is not taking advantage of this effective preventive health strategy.  With this recommendation, the USPSTF acknowledges that there is no ‘one size fits all’ approach to colorectal cancer screening and seeks to provide clinicians and patients with the best possible evidence about the various screening methods to enable informed, individual decision making.”

The final recommendations also recognize the use of Cologuard every three years, in keeping with the recommendation of the American Cancer Society and the coverage interval established by the Centers for Medicare and Medicaid Services. 

“We’re pleased with the clarity of these recommendations and expect they will expand and promote utilization of Cologuard as an innovative colon cancer screening option,” Mr. Conroy said.  ”The final USPSTF recommendations released today update the 2008 recommendations and reflect the rapid evolution that occurred among cancer screening technologies during the past eight years.  The recommendations offer patients a range of screening options that includes Cologuard, providing an opportunity to increase the number of people getting screened, detect more early-stage cancers, and eventually get closer to eradicating this preventable disease.”

The Task Force’s full recommendation statement can be found here.

About CologuardCologuard 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 U.S. Preventive Services Task Force, 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 Rx Only.