Exact Sciences Applauds Final Task Force Recommendation That Lowers Starting Age for Colorectal Cancer Screening to 45

National Task Force supports Cologuard® as a screening option and screening expands to an additional ˜19 million Americans

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EXACT SCIENCES CORP

May 18, 2021, 20:05 ET

MADISON, Wis., May 18, 2021 /PRNewswire/ -- The United States Preventive Services Task Force (USPSTF) today released its final colorectal cancer screening recommendation that screening begin at age 45. Exact Sciences' (NASDAQ: EXAS) Cologuard^®, referred to as sDNA-FIT, is included as a recommended screening option for all average-risk patients between the ages of 45 and 75.

Colorectal cancer is the second leading cause of cancer death in the United States, in part because many cancers go undetected until later stages when treatment options are limited.¹ Colorectal cancer can be prevented or detected early through screening. However, approximately 44 million average-risk adults 45-74 are currently eligible for screening, including _˜19 million between the ages of 45 and 49.^2§

According to this updated recommendation, all average-risk adults age 45 and older should now be screened for colorectal cancer. Colorectal cancer incidence has been increasing in American adults under the age of 50.³ Between 2004 and 2015, health care providers diagnosed more than 130,000 cases of colorectal cancer in Americans under age 50.⁴ More than half of these cases were diagnosed at later stages (stages III or IV), which are associated with lower survival rates than earlier stages (stages I or II).⁴ Only about one out of 10 people over the age of 50 with stage IV colorectal cancer survives beyond five years.¹

"Health care providers often turn to the USPSTF guidelines when discussing cancer prevention with their patients," said Paul Limburg, M.D., Chief Medical Officer, Screening at Exact Sciences. "These final guidelines will encourage more clinicians to offer colorectal cancer screening to their patients starting at age 45."

Cologuard is a U.S. Food & Drug Administration (FDA)-approved non-invasive stool DNA test used to screen for colorectal cancer in average risk patients. In a large clinical study of nearly 10,000 patients 50 and older, Cologuard found 92% of colorectal cancers,⁵ including 94% in stages I and II.^5,6,7* 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.

A recent study showed that among average-risk adults between the ages of 45 and 49, Cologuard demonstrated test specificity of 95.2% in participants with non-advanced precancerous lesions.⁷ In patients with negative colonoscopy findings, Cologuard demonstrated specificity of 96.3%^.7 According to the authors, using Cologuard to screen these younger individuals could help mitigate risks and reduce costs from unnecessary diagnostic procedures.

USPSTF guidelines play a key role in addressing the public health crisis caused by colorectal cancer. Under these final 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 (referred to in the guidelines as sDNA-FIT) among the recommended screening test options. Since it was first included in the 2016 USPSTF recommendation, Cologuard has been used to screen more than 5 million Americans.

"We are proud of the role Cologuard has played in getting more people screened for colorectal cancer," said Kevin Conroy, chairman and CEO of Exact Sciences. "The task force's recommendation that colorectal cancer screening begin at age 45 for all average risk people means that Cologuard can continue to positively impact screening rates as people work with their healthcare providers to choose the option that is right for them."

Making sure people have full access to using stool-based tests like Cologuard is critical to reaching the unscreened. A recent study conducted by researchers at Mayo Clinic showed that when given a choice, most individuals at average risk of colorectal cancer said they would prefer a stool-based screening test for colorectal cancer over colonoscopy.⁸

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

¹Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71:7-33. doi:10.3322/caac/21654

²Piscitello A, Edwards DKV. 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. doi:10.1158/1940-6207.CAPR-19-05

³Wolf 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. doi:10.3322/caac.21457

⁴Virostko 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;25(21):3828-3835. doi:10.1002/cncr.32347

⁵ 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. doi:10.1056/NEJMoa1311194

⁶ Ahlquist DA. Multi-target stool DNA test: a new high bar for non-invasive screening. Dig Dis Sci. 2015;60(3):623-633. doi:10.1007/s10620-014-3451-5

⁷Cologuard Physician Brochure. Exact Sciences Corporation. Madison, WI.

⁸Imperiale TF, Kisiel JB, Itzkowitz SH, et al. Specificity of the Multi-Target Stool DNA Test for Colorectal Cancer Screening in Average-Risk 45–49 Year-Olds: A Cross-Sectional Study. Cancer Prev Res. 2021;14(4):489-496. doi: 10.1158/1940-6207.CAPR-20-0294

⁹Zhu X, Parks PD, Weiser E. National Survey of Patient Factors Associated with Colorectal Cancer Screening Preferences. Cancer Prev Res. 2021;14(5):603-614. doi: 10.1158/1940-6207.CAPR-20-0524

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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 a follow-up 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.cologuard.com. Rx Only.

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