Exact Sciences Submits First Module of Premarket Approval Application to FDA
MADISON, Wis.--(BUSINESS WIRE)--
Exact Sciences Corp. (Nasdaq: EXAS) today announced that it has
submitted to the U.S. Food and Drug Administration the first module of
the premarket approval (PMA) application for its stool DNA colorectal
cancer screening test.
This module was comprised of the required documentation regarding the
manufacturing and quality control systems for the product. The modules
that remain to be submitted will include analytical and clinical data.
"The submission of the first, manufacturing module of our PMA
application is an important milestone for the company," said Kevin T.
Conroy, the company's president and chief executive. "With work on the
first module finished, we are focused on completing and submitting the
analytical and clinical modules."
The manufacturing module was submitted to the FDA on Friday, Dec. 7. The
FDA has up to 45 days to accept the submission.
A modular PMA submission is one in which the contents of a PMA are
broken into several 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's received,
which may allow for more rapid closure of the application.
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.
Exact Sciences Corp.
Source: Exact Sciences Corp.
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