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Exact Sciences Corp.
today announced that it has submitted to
the U.S. Food and Drug Administration the final module of the premarket
approval (PMA) application for Cologuard(TM), the company's stool DNA (sDNA)
colorectal cancer screening test. The final module, which is comprised of
data from the company's DeeP-C clinical trial, completes the company's PMA
application for the product.
The DeeP-C trial is one of the most extensive colorectal cancer screening
studies ever conducted in the United States. It analyzed data from
approximately 10,000 patients at 90 sites between the ages of 50 and 84 who
were at average risk for colorectal cancer.
"The completion of our PMA submission to the FDA is the most significant
milestone in the company's history and a big step forward in helping
physicians make the battle against colorectal cancer a winning one," said
Kevin T. Conroy, the company's president and chief executive. "I want to
thank the tremendous team at Exact Sciences and our collaborators for their
outstanding work. We share a passion for delivering our breakthrough
colorectal cancer screening test to the physicians and patients who need it.
Now, we look forward to continuing to work with the FDA through the review
process."
The final module was submitted to the FDA on Friday, June 7.
A modular PMA submission is one in which the contents of a PMA are broken
into clearly defined parts or modules. These modules are submitted
separately over time and comprise a complete PMA when all of them have been
completed. The FDA reviews each module as it is received, which may allow
for more rapid closure of the application.
The company will submit the DeeP-C study's pivotal data set for publication
in a peer-reviewed journal, presentation at a major medical meeting or both.
The company also announced the expansion of Maneesh K. Arora's chief
operating officer responsibilities to include the oversight of U.S. sales
and marketing. The company is in the process of building out its commercial
leadership team and is also conducting a search for a senior financial
officer.
"Maneesh is an invaluable partner who has been instrumental in developing
the company's commercial strategy and is the best person to lead a
successful launch of Cologuard," Mr. Conroy said.
About Exact Sciences Corp.
Exact Sciences Corp. 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-based 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.
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,
expected operating losses, anticipated results and timing of our pivotal
clinical trial, expectations concerning our ability to secure FDA approval
of our Cologuard test, expected license fee revenues, 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 obligation or undertaking to publicly release any
updates or revisions to any forward-looking statement contained herein (or
elsewhere) to reflect any change in our expectations with regard thereto or
any change in events, conditions or circumstances on which any such
statement is based.
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