Exact
Sciences Corp. (NASDAQ: EXAS) today announced that the American
Cancer Society’s Colorectal Cancer Prevention and Early Detection
national guidelines for colorectal cancer screening now reflect the
commercial availability of Cologuard, the company’s noninvasive stool
DNA colorectal cancer screening test.
The American Cancer Society (ACS) guidelines include Cologuard in a
recommended list of screening options for colorectal cancer. ACS
guidelines also reflect the Centers for Medicare and Medicaid Services
assessment that Cologuard be performed every three years for patients 50
and older who do not have symptoms of colorectal cancer and who do not
have an increased risk of colorectal cancer. Medicare covers Cologuard
for individuals age 50-85 fitting these criteria once every three years
at no cost to patients. Updated information on the ACS website also
describes the process by which patients can access Cologuard, including
information about collecting and sending samples to the lab for testing
and the latest information on Medicare coverage.
Available by prescription only, Cologuard is the first and only FDA
approved noninvasive stool DNA screening test for colorectal cancer.
Cologuard offers people 50 years and older who are at average risk for
colorectal cancer an easy to use screening test which they can do in the
privacy of their own home. Cologuard is designed to detect DNA
alterations and blood released from cancer and precancerous colon
lesions and has been proven to find 92 percent of colorectal cancers in
average risk patients with 87 percent specificity using only a single
sample. Cologuard does not require medication, dietary restrictions or
bowel preparation prior to taking the test.
“The ACS’ updated information regarding Cologuard is based on ACS’
inclusion of Exact Sciences’ first stool DNA test among the recommended
options for colorectal cancer screening in 2008, and the recent
availability of the new test. These updated guidelines mark a pivotal
benchmark in providing patients and clinicians with information and
access to this accurate and convenient colorectal cancer screening
option,” said Kevin Conroy, President, Chairman and CEO of Exact
Sciences. “Colorectal cancer remains the second-leading cancer killer in
the U.S. due to low screening rates. These guidelines provide people
with important information on the screening options available to them.
We hope these guidelines will also encourage more people to get screened
and contribute significantly to the ACS and National Colorectal Cancer
Roundtable shared goal of reaching 80% screened for colorectal cancer by
2018.”
Since 1980, the ACS has introduced and periodically updated guidelines
or guidance related to screening and/or informed decision-making about
tests for early detection of cancers of the breast, cervix, colon and
rectum, endometrium, lung and prostate. The ACS develops guidelines for
cancer screening to meet the needs of clinicians, the general public,
and policy.
About Exact Sciences Corp.
Exact Sciences Corp. (NASDAQ: EXAS) is a molecular diagnostics company
focused on the early detection and prevention of colorectal cancer. The
company has exclusive intellectual property protecting its noninvasive,
molecular screening technology for the detection of colorectal cancer.
Stool DNA technology is included in the colorectal cancer screening
guidelines of the American Cancer Society and the U.S. Multi-Society
Task Force on Colorectal Cancer. For more information, please visit the
company's website at www.exactsciences.com,
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
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release any updates or revisions to any forward-looking statement
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