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6/10/2013 10:42:26 AM
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Exact Sciences Submits Final Module and Completes Cologuard Premarket Approval Application to FDA, Expands Role of COO Arora
MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (Nasdaq: EXAS) 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™, 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.
Corporate Communications Contact:
The Luminis Group Ltd for Exact Sciences Corp.
Rod Hise, 608-770-7850
Media Relations Contact:
Jane Hauser, 781-684-0770
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