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.
1 Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2021. CA Cancer J
Clin. 2021;71:7-33. doi:10.3322/caac/21654
2 Piscitello 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
3 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. doi:10.3322/caac.21457
4 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;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
7 Cologuard 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
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 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.
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.
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