Healthcare Industry News:  colorectal cancer screening 

Diagnostics Oncology Gastroenterology

 News Release - October 14, 2019

Exact Sciences And Mayo Clinic Initiate 150,000 Patient, 7-Year Study To Evaluate Real-World Impact Of Cologuard(R)

Data from Prospective, Observational Study will Strengthen Clinical Evidence and Support Continued Cologuard Adoption

MADISON, Wis., Oct. 14, 2019 -- (Healthcare Sales & Marketing Network) -- (NASDAQ: EXAS) – Exact Sciences Corp. today announced that, in collaboration with Mayo Clinic, it has initiated the Voyage study to generate evidence of the real-world impact of Cologuard on colorectal cancer screening, incidence, and mortality rates. Voyage is a prospective, observational study designed to enroll more than 150,000 people with a valid Cologuard order and follow them for at least seven years to evaluate clinical outcomes. Voyage is one of the largest prospective, observational colorectal cancer screening studies ever conducted.

More than 50,000 Americans die from colorectal cancer each year, making it the second-leading cancer-killer in the U.S.i Screening can save lives by preventing the disease or detecting it early.ii Still, more than an estimated 40 percent of the 106 million eligible Americans aren't up-to-date with the American Cancer Society's colorectal cancer screening guidelines.iii Cologuard, the only FDA-approved, at-home colorectal cancer screening test, has the potential to help improve screening rates in this population.

Cologuard is 92 percent sensitive for colorectal cancer, 69 percent sensitive for high-risk pre-cancer, and backed by a nationwide user-navigation system, providing 24/7 support to improve compliance with screening. Over the past five years, Cologuard has helped screen more than 3 million people for colorectal cancer, with nearly half of surveyed users reporting never being screened previously. Today, Cologuard is widely accessible with 95 percent of users paying nothing out of pocket for the test.

"We applaud efforts to gather evidence on the performance and outcomes of colorectal cancer screening," said Paul Limburg, MD, MPH, AGAF, Exact Sciences chief medical officer. "This study will be instrumental in further demonstrating the clinical utility of Cologuard, a highly accurate, non-invasive screening option, in our collective effort to reduce the colorectal cancer burden."

Cologuard performance was initially validated in a 10,000 patient, prospective trial published in The New England Journal of Medicine in 2014. Voyage will provide additional, real-world evidence to demonstrate the clinical impact of Cologuard and help position it as standard-of-care in colorectal cancer screening.

About the Voyage Study

The Voyage study is a prospective, observational study to examine patient use of health services and related health outcomes among a cohort of average-risk adults prescribed Cologuard for routine colorectal cancer screening. The purpose of the Voyage study is to evaluate the real-world impact of Cologuard on colorectal cancer screening, incidence, and mortality rates. The study is designed to enroll over 150,000 adults with a valid Cologuard order and follow them for at least 7 years following the day of first enrollment. The Voyage study will be led by Mayo Clinic and enroll participants nationwide.

More information about the Voyage study can be found at NCT04124406.

[i] American Cancer Society, Cancer Facts & Figures 2019

[ii] Bibbins-Domingo K et al. for US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2016;315(23):2564-2575.

[iii] CDC NHIS survey results as published in the CDC's MMWR between 2006 and 2017

About Exact Sciences Corp.

Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of some of the deadliest forms of cancer. The company has exclusive intellectual property protecting its noninvasive, molecular screening technology for the detection of colorectal cancer. For more information, please visit the company's website at, follow Exact Sciences on Twitter @ExactSciences or find Exact Sciences on Facebook.

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 American Cancer Society's (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use if you have had adenomas, have inflammatory bowel disease and certain hereditary syndromes, or a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. False positives and false negative results can occur. In a clinical study, 13% of people without cancer received a positive result (false positive) and 8% of people with cancer received a negative result (false negative).

Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit Rx Only.

Forward-Looking Statements

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Source: Exact Sciences

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