New Model Shared at Digestive Disease Week (DDW) Demonstrates the Value of Cologuard® When Using Real-World Adherence Rates for Comparing Colorectal Cancer Screening Methods

CRC-AIM real-world microsimulation model shows Cologuard provides greater value than FIT in four key areas of measure

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May 05, 2020, 10:30 ET

MADISON, Wis., May 5, 2020 /PRNewswire/ -- New research from Exact Sciences Corp. (NASDAQ: EXAS) uses real-world-adjusted adherence rates in a colorectal cancer microsimulation, the Colorectal Cancer and Adenoma Incidence and Mortality model (CRC-AIM), to reinforce the value of Cologuard (mt-sDNA) as an effective colorectal cancer screening test. Cologuard offers significant advantages over the fecal immunochemical test (FIT) and real-world adherence data further highlights those advantages. Cologuard has higher sensitivity, a longer interval, and higher observed adherence rates in real-world usage. The modeling also highlights the importance of improving access to colonoscopy following a positive Cologuard or FIT test.

These results were accepted for presentation at DDW 2020 in a series of abstracts. They are now available on the DDW website.

Colorectal cancer (CRC) is the second leading cause of cancer death for men and women, in part because many cancers go undetected until later stages when treatment options are limited.¹Colorectal cancer can be prevented or detected early through screening; however, approximately 45 million Americans are not up to date with CRC screening.²

"Policymakers and other leaders often rely on modeling to make decisions about colorectal cancer screening," said Dr. Paul Limburg, Chief Medical Officer of Exact Sciences' screening business. "Modeling that incorporates real-life patient behaviors, and the impact of those behaviors on health outcomes, is limited. This new suite of abstracts provides insight into the effect that complex and dynamic patient patterns have on colorectal cancer screening outcomes."

Included below are titles, abstract numbers, and a brief summary of each abstract accepted for presentation at DDW.

Estimating the Impact of Imperfect Adherence to Stool-based Colorectal Cancer Screening Strategies on Comparative Effectiveness using the CRC-AIM Microsimulation Model
Abstract Number: Mo1598

Real-life adherence rates for CRC screening are imperfect and can vary widely by modality, health system setting, and use of patient compliance navigation programs. Cologuard (mt-sDNA) was recently shown to have high population-level adherence in a Medicare population, which researchers theorized was attributable to its noninvasive approach, widespread accessibility, and embedded patient navigation system. Using real-world adherence rates of 70% for mt-sDNA³ and 40-50% for FIT,⁴ the CRC-AIM microsimulation model estimated that the use of mt-sDNA resulted in an 8.4% to 19.1% increase in life-years gained (LYG) compared with FIT for screening ages 50-75 years.

More Fecal Immunochemical Tests are Needed to Match the Clinical Benefit of Equivalent Numbers of Multitarget Stool DNA Tests: CRC-AIM Microsimulation Model Results
Abstract Number: Su1773

Patient adherence to the annual testing regimes of FIT has proven difficult to achieve in real world settings.⁵ Predicted outcomes of annual FIT and triennial mt-sDNA were simulated for 4 million individuals between 50 and 75. At least twice as many FIT tests are needed to match the same clinical benefit compared with mt-sDNA testing (21 vs. 9) using guideline recommended CRC screening initiation age and test interval.

Microsimulation Study of Life-Years Gained from Screening vs. Follow-up Colonoscopy using the CRC-AIM Model
Abstract Number: Sa1658

Health care providers often face a challenge ensuring patient adherence to follow-up colonoscopy after a positive stool-based test. Current reimbursement and coverage policies can trigger patient cost-sharing when patients seek necessary follow-up colonoscopy or when a screening colonoscopy turns diagnostic, depending upon health insurance benefits. In a third study leveraging the CRC-AIM model, the analysis showed that there are approximately 3-to-5 times more LYG per colonoscopy when the colonoscopy was performed as a diagnostic follow-up to a positive stool-based test rather than as a screening colonoscopy alone.

"All too often, colonoscopies following a positive stool-based test and screening colonoscopies that turn diagnostic do not receive full reimbursement from insurers, which can prevent patients from scheduling them," said Kevin Conroy, chairman and CEO. "These data show the urgent need to remove cost barriers for these colonoscopies as they have a measurable positive impact on patient lives."

Higher Impact on Clinical Outcomes from Delays in Colorectal Cancer Screening with the Fecal Immunochemical Test vs. Multitarget Stool DNA: CRC-AIM Microsimulation Model Results
Abstract Number: Tu1822

One obstacle to CRC screening is a delay in the start of screening or a lack of adherence to repeat testing. For example, screening rates among people 50 to 54 years old are only 50%, according to recent CDC data.⁶The assumption in this modeling analysis was that recommended triennial mt-sDNA or annual FIT was delayed by 12, 18, or 24 months every time screening was due. The reduction in CRC-related mortality with a 12, 18, and 24-month delay for patients 50 to 75 was greater with triennial mt-sDNA (67%, 63%, and 59%, respectively) than annual FIT (65%, 59%, and 53%). The relative efficacy of mt-sDNA was better than FIT when considering these clinically realistic delayed screening adherence scenarios.

To promote transparency and the credibility of this new model, Exact Sciences has made available CRC-AIM's formulas and parameters at https://github.com/CRCAIM/CRC-AIM-Public so other researchers and members of the modeling community can address outstanding questions related to CRC screening.

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 solutions providing the clarity to take life-changing action, earlier. Building on the success of Cologuard and Oncotype DX, Exact Sciences is investing in its product pipeline to take on some of the deadliest cancers and improve patient care. 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.

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) 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 precancer, 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.

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

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Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, anticipated results of our sales, marketing and patient adherence efforts, expectations concerning payer reimbursement and regulatory matters, the anticipated results of our product development efforts and the anticipated benefits of our combination with Genomic Health, Inc., including estimated synergies and other financial impacts. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. 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Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and healthcare providers; our ability to meet demand for our products and services; the success of our efforts to facilitate patient access to Cologuard via telehealth, the willingness of health insurance companies and other payers to cover our products and services and adequately reimburse us for such products and services; the amount and nature of competition in the cancer detection, treatment guidance and monitoring space; the effects of the adoption, modification or repeal of any law, rule, order, interpretation or policy relating to the healthcare system, including without limitation as a result of any judicial, executive or legislative action; the effects of changes in pricing, coverage and reimbursement for our products and services, including without limitation as a result of the Protecting Access to Medicare Act of 2014; recommendations, guidelines and quality metrics issued by various organizations such as the U.S. Preventive Services Task Force, the American Society of Clinical Oncology, the American Cancer Society, and the National Committee for Quality Assurance regarding cancer screening or our products and services; our ability to successfully develop new products and services and assess potential market opportunities; our ability to effectively utilize strategic partnerships, such as through our Promotion Agreement with Pfizer, Inc., and acquisitions; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to maintain regulatory approvals and comply with applicable regulations; our ability to manage an international business and our expectations regarding our international expansion and opportunities; the potential effects of foreign currency exchange rate fluctuations and our efforts to hedge such effects; the possibility that the anticipated benefits from our combination with Genomic Health cannot be realized in full or at all or may take longer to realize than expected; the possibility that costs or difficulties related to the integration of Genomic Health's operations will be greater than expected and the possibility of disruptions to our business during integration efforts and strain on management time and resources; the outcome of any litigation, government investigations, enforcement actions or other legal proceedings; and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q. 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.

American Cancer Society. Survival rates for colorectal cancer. https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html. Accessed April 30, 2020.
Piscitello A, Edwards DK. Estimating the screening-eligible population size, aged 45 to 74, at average risk to develop colorectal cancer in the United States. Cancer Prev Res. Published OnlineFirst February 6, 2020.
Weiser E, et al. J Med Screen. 2020; In Press: DOI: 10.1177/0969141320903756
Hassan C, et al. Aliment Pharmacol Ther. 2012;36(10):929-940.
Ibid
Joseph DA, King JB, Dowling NF, Thomas CC, Richardson LC. Vital Signs: Colorectal Cancer Screening Test Use — United States, 2018. MMWR Morb Mortal Wkly Rep 2020; 69:253–259. DOI: http://dx.doi.org/10.15585/mmwr.mm6910a1