MADISON, Wis., Jan. 12, 2021 /PRNewswire/ -- Exact Sciences
Corp. (Nasdaq: EXAS) announced data published today in Cancer
Prevention Research, a Journal of the American Association for
Cancer Research, that expands on foundational clinical study
findings to include a key younger population. Study results show
that among average-risk adults between the ages of 45 and 49
Cologuard® (mt-sDNA) demonstrated test specificity of 95.2% in
participants with non-advanced precancerous lesions or negative
findings at colonoscopy and 96.3% in only those with negative
colonoscopy findings. These analyses support potential risk
mitigation and cost prevention due to unnecessary diagnostic
procedures when using Cologuard as a colorectal cancer screening
tool in this younger population.
Study is among the first to evaluate the use of a colorectal cancer
screening method in patients between ages of 45-49.
Cologuard is a U.S. Food & Drug Administration
(FDA)-approved, non-invasive stool DNA test for colorectal cancer
for average-risk people. 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.
"These new data support the critical role an effective,
non-invasive option like Cologuard plays in screening people ages
45 to 49," said Kevin Conroy,
chairman and CEO of Exact Sciences. "Cologuard may appeal to this
younger screening population because they can collect sample at
home, without missing work or undergoing bowel prep and anesthesia,
and only those patients with a positive Cologuard will require a
In a previously published, large clinical study of nearly 10,000
patients 50 and older, Cologuard found 92% of colorectal cancers,
including 94% in stages I and II. Specificity for this over 50
population was 87%.
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 is less effective. Colorectal cancer
can be prevented or detected early through screening; however,
approximately 44 million Americans remain unscreened, including an
estimated 19 million between ages 45 and 49.
The incidence of colorectal cancer in people under the age of 50
has dramatically increased in the last 20 years. Between 2004 and
2015, health care providers diagnosed more than 130,000 cases of
colorectal cancer in Americans under age 50. More than half of
these cases were diagnosed at an advanced stage, stage III or stage
IV, when survival rates are low.
"This study is among the first to evaluate the use of a
colorectal cancer screening method in patients between the ages of
45 and 49," said Paul Limburg,
M.D., Chief Medical Officer, Screening at Exact Sciences. "The
American Cancer Society guidelines and the 2020 draft United States
Preventive Services Task Force (USPSTF) guidelines now say that
screening should begin at 45, and these data support the use of
Cologuard as a first line screening option."
The prospective study included 816 evaluable participants who
all completed a Cologuard test and underwent a colonoscopy.
Participants were enrolled at 31 sites in the United States from November 2018 through June
2019. They completed Cologuard, followed by a screening
colonoscopy within approximately 60 days of enrollment.
Participants collected their sample for the Cologuard test prior to
doing any bowel preparation necessary for the colonoscopy. All
colonoscopies were performed blinded to the Cologuard results.
Specificity was the primary outcome and was measured in
participants without colorectal cancer or advanced precancerous
lesions and in the subgroup of participants with negative
colonoscopic findings. None of the study participants had
colorectal cancer, 49 had advanced precancerous lesions, 253 had
non-advanced adenomas and 514 had negative colonoscopies.
Specificity did not differ between men and women.
Investor Relations Contact:
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.
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
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. Therefore, 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
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SOURCE EXACT SCIENCES CORP