Exact Sciences Extends Leadership in Colorectal Cancer Screening with New Data Presented at Digestive Disease Week® Annual Meeting

Published: May 09, 2023

Results of three modeling studies demonstrated that non-invasive colorectal cancer screening with Cologuard^® is more effective when compared to hypothetical blood-based screening^1-3

MADISON, Wis., May 9, 2023 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, presented new data supporting the company's research and innovation in colorectal cancer (CRC) during Digestive Disease Week^® (DDW) 2023, May 6-9 in Chicago, Illinois.

"The ability to detect advanced adenomas is important," said Seth A. Gross, M.D., NYU Langone Health.

Among nine abstracts presented at the meeting were results from three modeling studies estimating health outcomes of stool- and blood-based CRC screening strategies in people at average risk of CRC.^1-3 Exact Sciences collaborated with nearly 20 medical experts from some of the leading health systems in the United States, with the collective results supporting Cologuard^® as a superior, non-invasive screening option for the detection of cancers and pre-cancers.⁴

"When considering colorectal cancer screening methods, it's important to determine the goals. A screening test must have good sensitivity to detect cancers and pre-cancers," said Seth A. Gross, M.D., NYU Langone Health. "The ability to detect advanced adenomas is important—a patient with an advanced adenoma has a higher risk of developing colorectal cancer and currently, we have dependable tools that can detect cancers and pre-cancers in the colorectal anatomy. Any future, frontline screening test for colorectal cancer must have the same or better abilities."

"Deciding which strategy to adopt for colorectal cancer screening can be challenging for patients and their providers. The data presented at DDW offer further insights into selecting accurate and accessible non-invasive CRC screening methods," said Paul Limburg, M.D., M.P.H., A.G.A.F., chief medical officer for screening, Exact Sciences. "Exact Sciences is committed to research that helps understand and prevent colorectal cancer and reduce the burden and mortality of this all-too-common disease."

Exact Sciences' Screening portfolio data highlights at DDW 2023

Poster #Tu1116: Estimated impact of adenoma and colorectal cancer early detection on health outcomes and screening effectiveness

Presenter: Burak Ozbay, Ph.D., Exact Sciences
Presented on: Tuesday, May 9, 12:30 p.m. - 1:30 p.m. CT
Location: South Hall A, Poster Hall

Adenoma detection is critical to achieve positive clinical and economic outcomes from CRC screening. When adenomas are detected via screening, they can be removed before developing into cancer. A new modeling study comparing Cologuard (multi-target stool DNA or mt-sDNA) and fecal immunochemical testing (FIT) looked at the estimated life-years gained (LYG) from screening and how they were achieved. LYG is a health economics measure that describes the additional years of life a person or population gains as a result of a medical intervention such as CRC screening. Results showed that estimated LYG from average-risk screening were more strongly associated with adenoma detection than early-stage CRC detection.¹

The study used the cross-validated Colorectal Cancer-Adenoma Incidence and Mortality (CRC-AIM) microsimulation model, which Exact Sciences developed to estimate the human impact of different CRC screening strategies. Using real-world screening adherence rates, the CRC-AIM model estimated that Cologuard resulted in 30% more LYG when compared to FIT.¹

Poster #Tu1114: Estimated adenoma sensitivity threshold needed for blood-based colorectal cancer screening tests to be as effective as stool-based screening tests
Presenter: John B. Kisiel, M.D., Mayo Clinic
Presented on: Tuesday, May 9, 12:30 p.m. - 1:30 p.m. CT
Location: South Hall A, Poster Hall

Poster #Tu1113: Colorectal cancer screening with blood-based tests: estimated impact of a 1-, 2-, or 3-year screening interval on benefits and harms compared with annual FIT and triennial mt-sDNA strategies
Presenter: Burak Ozbay, Ph.D., Exact Sciences
Presented on: Tuesday, May 9, 12:30 p.m. - 1:30 p.m. CT
Location: South Hall A, Poster Hall

Blood-based screening for CRC faces inherent biological barriers, especially in adenoma detection. Results of two additional modeling analyses suggest that in average-risk individuals, blood-based tests with performance characteristics that merely meet the Centers for Medicare & Medicaid Services (CMS) minimum thresholds will underperform when compared to Cologuard, resulting in fewer LYG overall and/or more colonoscopies required.^2-3

In the first study (#Tu1114), the CRC-AIM model was used to simulate outcomes of triennial blood-based CRC screening with a hypothetical test meeting CMS minimum performance thresholds, annual FIT testing, and triennial Cologuard screening. The results showed that the adenoma sensitivity of a blood test would need to meet or exceed 40% in real-world and perfect adherence scenarios to achieve comparable LYG to the existing guideline-recommended, stool-based tests. The authors concluded that blood-based CRC screening would need to exceed CMS-defined performance thresholds and provide sufficient adenoma detection to offer comparable LYG to Cologuard.²

In the second study (#Tu1113), the CRC-AIM model explored the impact of 1-, 2-, and 3-year blood-based screening intervals on estimated clinical outcomes compared to annual FIT and triennial Cologuard screening. In real-world and perfect adherence scenarios, blood-based tests meeting CMS minimum performance thresholds with low advanced adenoma sensitivity (10%) achieved fewer LYG than stool-based tests at any screening interval. In both adherence models, biannual and triennial blood-based tests with 20% advanced adenoma sensitivity were estimated to yield fewer LYG than stool-based tests. The tests only reached higher LYG at one-year intervals, where they also generated 49% more follow-up colonoscopies, introducing more potential harm to patients.³

Additional data presentations from Exact Sciences at today's Colorectal Diseases sessions at DDW 2023^5-10

Poster #Tu1115: Estimated value-based pricing for Guardant Health Shield blood-based colorectal cancer screening test versus multi-target stool DNA test
Presenter: John B. Kisiel, M.D., Mayo Clinic
Presented on: Tuesday, May 9, 12:30 p.m. - 1:30 p.m. CT
Location: South Hall A, Poster Hall

Poster #Tu1117: Cost-effectiveness of stool-based colorectal cancer screening programs from a Health System Perspective
Presenter: Amber Coleman, Pharm.D., Exact Sciences
Presented on: Tuesday, May 9, 12:30 p.m. - 1:30 p.m. CT
Location: South Hall A, Poster Hall

Poster #Tu1551: Cost-effectiveness of hepatocellular carcinoma surveillance programs using multi-target blood test
Presenter: Burak Ozbay, Ph.D., Exact Sciences
Presented on: Tuesday, May 9, 12:30 p.m. - 3:00 p.m. CT
Location: South Hall A, Poster Hall

Data presented earlier at DDW 2023

Poster #Sa1005: Trends in colorectal cancer screening adherence and modality utilization at a large tertiary care center
Presenter: Catherine Cheney, M.D., Duke University Medical Center
Presented on: Saturday, May 6, 12:30 p.m. - 1:30 p.m. CT
Location: South Hall A, Poster Hall

Poster #Sa1006: Trends in follow-up colonoscopy completion after a positive stool-based screening test for colorectal cancer at a large health care system
Presenter: Catherine Cheney, M.D., Duke University Medical Center
Presented on: Saturday, May 6, 12:30 p.m. - 1:30 p.m. CT
Location: South Hall A, Poster Hall

Presentation #730: Impact of surveillance and social determinants of health on treatment receipt and healthcare costs in patients with HCC
Presenter: Amit Singal, M.D., UT Southwestern Medical Center
Presented on: Monday, May 8, 2:45 p.m. - 3:00 p.m. CT
Location: S402, South Level 4

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and their health care providers the clarity needed to take life-changing action, earlier. The company unites visionary collaborators to help advance the fight against cancer. Building on the success of the Cologuard^® and Oncotype^®tests, Exact Sciences is investing in its pipeline to create innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit ExactSciences.com, follow Exact Sciences on Twitter @ExactSciences, or find Exact Sciences on Facebook.

About Cologuard^®

The Cologuard test 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. The Cologuard test is included in the American Cancer Society's (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2021) and National Comprehensive Cancer Network (2016). The Cologuard test 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 the Cologuard test if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. The Cologuard test is not a replacement for colonoscopy in high-risk patients. The Cologuard test performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. The Cologuard test 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 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. Medicare and most major insurers cover the Cologuard test.

For more information about the Cologuard test, visit www.cologuard.com. Rx only.

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.

References

[1] Ozbay, B, et al. Abstract #Tu1116, DDW 2023.

[2] Kisiel, J, et al. Abstract #Tu1114, DDW 2023.

[3] Ozbay, B, et al. Abstract #Tu1113, DDW 2023.

[4] Imperiale TF, et al. N Engl J Med. 2014;370(14):1287-1297.

[5] Kisiel, J, et al. Abstract #Tu1115, DDW 2023.

[6] Coleman, A, et al. Abstract #Tu1117, DDW 2023.

[7] Ozbay, B, et al. Abstract #Tu1551, DDW 2023.

[8] Cheney, C, et al. Abstract #Sa1005, DDW 2023.

[9] Cheney, C, et al. Abstract #Sa1006, DDW 2023.

[10] Singal, A, et al. Abstract #730, DDW 2023.

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