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

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 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.^4§

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.⁹ 

"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 10^th, 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.

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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.

⁷ 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.

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