Exact Sciences Commends Task Force for Draft Updated Guidelines that include Colorectal Cancer Screening Beginning at Age 45

October 27, 2020
Cologuard® remains a recommended screening method in the draft

MADISON, Wis., Oct. 27, 2020 /PRNewswire/ -- The United States Preventive Services Task Force (USPSTF) today released draft updated colorectal cancer screening guidelines recommending that screening begin at age 45, and including Exact Sciences' (NASDAQ: EXAS) Cologuard® (referred to in the draft guidelines as sDNA-FIT) as a recommended screening method for all average-risk patients between the ages of 45 and 75.

Cologuard® remains a recommended screening method in the draft

Cologuard is a U.S. Food & Drug Administration (FDA)-approved non-invasive stool DNA test for colorectal cancer. In a large clinical study of nearly 10,000 patients 50 and older, Cologuard found 92% of colorectal cancers,1 including 94% in stages I and II.2* In September 2019, the FDA approved Cologuard for average-risk individuals beginning at age 45, expanding the Cologuard label to include this critical younger adult population.

Colorectal cancer is the second leading cause of cancer death for men and women in the United States, in part because many cancers go undetected until later stages when treatment options are limited.3 Colorectal cancer can be prevented or detected early through screening; however, approximately 44 million Americans remain unscreened, including 19 million between ages 45 and 49.

USPSTF guidelines play a key role in addressing the public health crisis caused by colorectal cancer. Under the updated draft guidelines, colorectal cancer screening remains a Grade A recommendation for people ages 50-75 and screening for ages 45 to 49 is a Grade B recommendation. The task force continues to include Cologuard among the recommended screening test options. Since inclusion in the 2016 guidelines, Cologuard has been used to screen more than 4 million Americans. Screening rates are increasing5 and CRC mortality is declining in patients over the age of 50.6

Including patients 45 and older in the USPSTF guidelines would address the increasing incidence of colorectal cancer among American adults under the age of 50.7 Between 2004 and 2015, health care providers diagnosed more than 130,000 cases of colorectal cancer in Americans under age 50.8 More than half of these cases were diagnosed at an advanced stage, stage III or stage IV, when survival rates are low.8 About one out of 10 people over the age of 50 with stage IV colorectal cancer survives beyond five years.3

"Exact Sciences commends the members of the USPSTF for lowering the screening age and recommending Cologuard among multiple screening test options," said Kevin Conroy, chairman and CEO of Exact Sciences. "The confidence in and influence of the guidelines will without a doubt encourage more clinicians to offer screening to their patients starting at 45."

New research presented at this week's American College of Gastroenterology (ACG) meeting highlights that colorectal cancer screening rates have increased since 2014 and that Cologuard was a significant driver of that increase.9 This increase correlates with Cologuard's inclusion in the 2016 USPSTF colorectal cancer screening guidelines which was a major catalyst for the adoption of Cologuard.

"The draft updated USPSTF guidelines along with the data presented at ACG illuminate the fact that when patients are included in discussions around their choice of screening method, they are more likely to participate in colorectal cancer screening," said Paul Limburg, M.D., Chief Medical Officer, Screening at Exact Sciences. "We believe these draft guidelines will encourage clinicians to continue supporting patient choice and informed decision making."

Research indicates offering Cologuard may result in higher screening rates among unscreened patients. In one study of Medicare patients who were not up to date with colorectal cancer screening, 88% completed a Cologuard test within one year of the test order date. And of those who needed a diagnostic colonoscopy for a positive Cologuard result, 96% underwent the follow-up procedure.10

Including an at-home choice for colorectal cancer screening in the USPSTF guidelines has never been more important. As the United States battled COVID-19, many offices closed and colonoscopies were canceled, creating a modeled impact of an estimated 1.7 million missed colonoscopies (3 months ending June 5, 2020).11‡  Cologuard gives clinicians and patients a convenient, user-friendly way to get screened without delay and without having to leave home.

Following the USPSTF's four-week public comment period and subsequent review, a final recommendation statement is expected to be announced in 2021.

*Statistic calculated using data from the pivotal study and reported within the Ahlquist review article. Cologuard sensitivity, per stage of cancer: I: 90% (n=29); II: 100% (n=21); III: 90% (n=10); IV: 75% (n=4).1

§Estimates based on the US population aged 45-74 and 45-49 respectively as of 2018, adjusted for the reported rates of high-risk conditions and prior screening history for CRC.

Data are from pre-adjudicated claims collected from office-based physicians and specialists from more than 205 million patients with over 1.7 billion claims and 3 billion service records obtained. Reduced numbers of claims are from IQVIA Real World Claims data, based on National claims data up to April 10th, 2020. Periods until June 5th assumed to remain as low as the latest week resulting in a three-month reduction compared to the baseline month of February 2020. Calculation based on 9.5M colonoscopies annually/12 months*72% reduction*3 months.


1 Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297.

2 Ahlquist DA. Multi-target stool DNA test: a new high bar for non-invasive screening. Dig Dis Sci. 2015;60(3):623-633.

3 Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020;70(1):7-30.

4 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. 2020;13(5):443-448.

5 CDC. Use of colorectal cancer screening tests.  https://www.cdc.gov/cancer/colorectal/statistics/use-screening-tests-BRFSS.htm. Updated October 22, 2019. Accessed October 26, 2020.

6 NCI. SEER cancer stat facts: colorectal cancer. 2020. https://seer.cancer.gov/statfacts/html/colorect.html. Accessed October 26, 2020.

Wolf A, Fontham E, Church TR, et al. Colorectal cancer screening for average-risk adults: 2018 guideline update from the American Cancer Society. CA Cancer J Clin. 2018;68:250-281.

8 Virostko J, Capasso A, Yankeelov TE, et al. Recent trends in the age at diagnosis of colorectal cancer in the US National Cancer Data Base, 2004-2015. Cancer. 2019;0:1-8.

9 Fisher DA, Princic N, Miller-Wilson LA, et al. Colorectal cancer screening by test type prior to and following mt-sDNA market entry among average risk patients: a real world analysis." Virtual 2020 American College of Gastroenterology (ACG) Annual Scientific Meeting held October 23-28, 2020. Poster #P0742

10 Prince M, Lester L, Chiniwala R, Berger B. Multitarget stool DNA tests increases colorectal cancer screening among previously non-compliant Medicare patients. World J Gastroenterol. 2017;23(3):464-471.

11 IQVIA Institute for Human Data Science. Shifts in healthcare demand, delivery and care during the COVID-19 era. April 2020.  https://www.iqvia.com/insights/the-iqvia-institute/covid-19/shifts-in-healthcare-demand-delivery-and-care-during-the-covid-19-era. Accessed October 26, 2020.

Media Contact:
Cara Connelly, cconnelly@exactsciences.com, 614-302-5622

Investor Contact:
Megan Jones, meganjones@exactsciences.com, 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.

Forward-Looking Statements

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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 the anticipated results of our product development efforts, the anticipated benefits of our pending acquisition of Thrive Earlier Detection Corporation ("Thrive"), including estimated synergies and other financial impacts, and the expected timing of completion of the transaction.  Forward-looking statements are neither historical facts nor assurances of future performance or events. 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. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results, conditions and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. 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 the coronavirus (COVID-19) pandemic, including its possible effects on our operations, including supply chain, 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 for our products and services; 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 enter into and 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 and the ability of Thrive and Base Genomics Limited ("Base") 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 business acquisitions (including the pending acquisition of Thrive and recent acquisition of Base) 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 acquired businesses' (including Thrives and Base'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; the ability of the Company and Thrive to receive the required regulatory approvals for the pending merger and to satisfy the conditions to the closing of the transaction on a timely basis or at all; the occurrence of events that may give rise to a right of one or both of the Company and Thrive to terminate the merger agreement; possible negative effects of the announcement or the consummation of the pending acquisition of Thrive or recent acquisition of Base on the market price of our common stock and/or on our and/or Thrive's or Base's respective businesses, financial conditions, results of operations and financial performance; significant transaction costs and/or unknown liabilities; risks associated with contracts containing consent and/or other provisions that may be triggered by the pending acquisition of Thrive or the recent acquisition of Base; risks associated with potential transaction-related litigation; the ability of Thrive, Base and the combined company to retain and hire key personnel; 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. 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