New Cologuard® Modeling Data Show Patient Navigation Matters When Reaching Underserved Populations for Colorectal Cancer (CRC) Screening

By Exact Sciences / October 26, 2021

MADISON, Wis.- October 25, 2021 - Exact Sciences Corp. (NASDAQ: EXAS)today shared data from modeling analyses that demonstrate Cologuard (mt-sDNA), with its included patient navigation system, provides a greater reduction in incidence and mortality from colorectal cancer (CRC) compared to annual fecal immunochemical test (FIT), when it included outreach, with or without a mailed annual FIT, using real world adherence rates in a simulated Medicaid population. Cologuard remained cost-effective in all the real-world adherence scenarios modeled. The modeling analyses were consistent with the CISNET Colorectal Working Group models when using 100% adherence rates.

The Exact Sciences Laboratories Patient Navigation Program features on-demand phone support, reminder phone calls, texts and emails at no additional cost with each Cologuard test ordered.

These new data, generated from the CRC-AIM microsimulation model, will be presented in an ACG Presidential Award-winning poster titled, "Cost-Effectiveness of Stool-Based Colorectal Cancer Screening Using Reported Real-World Adherence Rates in a Medicare Population." (P1181)

"Colorectal cancer screening rates need improvement, and they are particularly low in vulnerable populations,"^[1]said Paul Limburg, M.D., Chief Medical Officer, Screening at Exact Sciences. "Exact Sciences Laboratories' patient navigation program answers any question around sample collection and offers phone and text reminders to complete the testing process. It is a way to help all patients, including vulnerable patients, prioritize their health and get up to date with CRC screening."

Colorectal cancer is the second deadliest cancer impacting both men and women in the U.S. Earlier detection of colorectal cancer through effective screening has been shown to improve clinical outcomes.^[2],[3]

All abstracts and posters presented at the meeting can be accessed through this link.Additional Cologuard abstracts accepted for presentation include:

Adherence to colorectal cancer screening and associated healthcare resource utilization, a longitudinal analysis in US Medicare population with ten years follow-up(PO246)

Colorectal cancer screening rates and associated characteristics among US Medicare beneficiaries aged 66-75 years old in 2016-2018 (PO245)

Impact of mt-sDNAin a colorectal cancer screening clinical practice: a real-world survey(PO247)

Multitarget stool DNA testing has a high positive predictive value for colorectal neoplasia on the second round of testing(P1318)

Initial colorectal cancer screenings after turning 50-year-old and follow-up screening patterns after positive FIT or multitarget stool DNA testing among average-risk population(P1330)

Colorectal cancer screening and adherence rates among average-risk population enrolled in a national health insurance provider during 2009-2018(P2345)

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Media Contact:

Cara Connelly, [email protected], 614-302-5622

Investor Contact:

Megan Jones, [email protected], 608-535-8815

About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter answers to give people the clarity to take life-changing action, earlier. Building on the success of Cologuard and Oncotype^®tests, Exact Sciences is investing in its product pipeline to support patients throughout their cancer diagnosis and treatment. Exact Sciences unites visionary collaborators to help advance the fight against cancer. For more information, please visit the company's website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook.

Note: Oncotype is a registered trademark of Genomic Health, Inc. Exact Sciences and Cologuard are trademarks or registered trademarks of Exact Sciences Corporation.

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 in adults 50 years of age or older 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, 2021) 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 Cologuard if you have had adenomas, have inflammatory bowel disease and certain hereditary syndromes, or have 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). Rx only.

Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuard.com.

Forward-Looking Statements
This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. You should not place undue reliance on forward-looking statements. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

[1]American Cancer Society. Colorectal Cancer Facts & Figures 2020-2022. Atlanta: American Cancer Society; 2020.

[2]Davidson KW, Barry MJ, Mangione CM, et al. Screening for colorectal cancer - US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977.

[3]Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71:7-33. doi:10.3322/caac/21654

Topics: Colon Cancer News and Information, Press Releases