Peer-Reviewed Study Shows Increased Sensitivity, Reduced
False-Positive Rate
MADISON, Wis.--(BUSINESS WIRE)--
Exact
Sciences Corp. (NASDAQ: EXAS) today announced that a new
peer-reviewed study of Cologuard®, a multi-target stool DNA test
(MT-sDNA), confirms its performance across all stages of colorectal
cancer and showcases how the at-home test could improve access to
screening. In the study of 661 average risk Alaska Native people,
Cologuard detected 100% (10/10) of colorectal cancers and 52% (24/46) of
significant premalignant lesions (adenomas > 1 cm) in people between the
ages of 40-85. The detection rate of Cologuard increased to 80% for the
largest pre-cancers ( > 3 cm), which are most likely to progress to
cancer. The study,
'Stool DNA Testing for Screening Detection of Colorectal Neoplasia in
Alaska Native People' is published in today's Mayo Clinic Proceedings.
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New Study Bolsters Cologuard's Performance in Detecting Colorectal Cancer and Ability to Improve Access to Screening (Photo: Business Wire)
The Alaska Native people have among the world's highest rates of
colorectal cancer, more than twice the rate of U.S. Caucasians.
Colorectal cancer is also the most commonly diagnosed cancer among this
population. Conventional invasive screening approaches, such as
colonoscopy, present access challenges for people in remote Alaskan
villages. The colorectal cancer screening rate for some Alaska Native
people is as low as 23%, far below the national screening rate of 58%.
'This research is further evidence that Cologuard is highly sensitive in
detecting both early stage colorectal cancer and the most advanced
precancerous polyps that are most likely to develop into cancer,' said
David Ahlquist, M.D., a Mayo Clinic gastroenterologist, study
investigator and co-inventor of the test. 'A sensitive screening test
like Cologuard that is delivered to a patient's home provides an
opportunity to reverse that trend not only in Alaska but also in other
rural and remote areas where patients have limited access to screening.'
As part of the study, which mirrored a previously published (New Engl
J Med April 2014) 10,000 patient prospective study of Cologuard,
participants underwent both Cologuard and fecal immunochemical testing
(FIT) prior to a pre-scheduled screening or surveillance colonoscopy.
The Alaska Native study results improved upon the previously published
results, showing a higher rate of sensitivity for colorectal cancer and
pre-cancer and an increased specificity. FIT detected 80% (8/10) of
colorectal cancers and only 30% of significant premalignant lesions
(adenomas > 1 cm). Cologuard achieved a specificity of 93% and FIT
achieved a specificity of 96%.
'This study of Alaska Native people confirms the power of Cologuard and
reaffirms its importance in our effort to increase America's stagnating
colon cancer screening rates,' said Kevin Conroy, chairman and CEO of
Exact Sciences. 'Not only did Cologuard's sensitivity remain high across
all cancer stages and pre-cancers, but its false positive rate
decreased. Cologuard's performance highlights its role as a screening
option.'
Mayo Clinic and Dr. Ahlquist have a financial interest in the technology
described in this news release.
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 were published in the New England Journal of Medicine in
April 2014. Cologuard is included in the colorectal cancer screening
guidelines of the American Cancer Society and stool DNA is listed in the
screening guidelines of the U.S. Multi-Society Task Force on Colorectal
Cancer.
Cologuard is indicated to screen adults of either sex, 50 years or
older, who are at average risk for colorectal cancer. Cologuard is not
for everyone and is not a replacement for diagnostic colonoscopy or
surveillance colonoscopy in high-risk individuals. False positives and
false negatives do occur. Any positive test result should be followed by
a diagnostic colonoscopy. Following a negative result, patients should
continue participating in a screening program at an interval and with a
method appropriate for the individual patient. Cologuard performance
when used for repeat testing has not been evaluated or established. For
more information about Cologuard, visit www.CologuardTest.com.
Rx Only.
About Exact Sciences Corp.
Exact Sciences Corp. is a molecular diagnostics company focused on the
early detection and prevention of some of the deadliest forms of cancer.
The company has exclusive intellectual property protecting its
noninvasive, molecular screening technology for the detection of
colorectal cancer. Cologuard is included in the colorectal cancer
screening guidelines of the American Cancer Society and stool DNA is
included in the guidelines of the U.S. Multi-Society Task Force on
Colorectal Cancer. For more information, please follow us on Twitter @ExactSciences or
find us on Facebook.
Certain statements made in this news release contain forward-looking
statements within the meaning of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities and Exchange Act of
1934, as amended that are intended to be covered by the 'safe harbor'
created by those sections. Forward-looking statements, which are based
on certain assumptions and describe our future plans, strategies and
expectations, can generally be identified by the use of forward-looking
terms such as 'believe,' 'expect,' 'may,' 'will,' 'should,' 'could,'
'seek,' 'intend,' 'plan,' 'estimate,' 'anticipate' or other comparable
terms. Forward-looking statements in this news release may address the
following subjects among others: statements regarding the sufficiency of
our capital resources, our ability to secure favorable reimbursement
rates from Medicare and other third-party payors, timing of our launch
of a commercial product, our estimates of the available market size and
our potential penetration, expected research and development expenses,
expected general and administrative expenses and our expectations
concerning our business strategy. Forward-looking statements involve
inherent risks and uncertainties which could cause actual results to
differ materially from those in the forward-looking statements, as a
result of various factors including those 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. We urge you to consider those
risks and uncertainties in evaluating our forward-looking statements. We
caution readers not to place undue reliance upon any such
forward-looking statements, which speak only as of the date made. Except
as otherwise required by the federal securities laws, we disclaim any
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based.
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Exact Sciences Corp.
Cara Tucker, 614-302-5622
ctucker@exactsciences.com
or
MSL
GROUPJayme Maniatis or Jane Hauser, 781-684-0770
exactsciences@mslgroup.com
Source: Exact Sciences Corp.
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