Exact Sciences Submits Final Module and Completes Cologuard Premarket Approval Application to FDA, Expands Role of COO Arora

Exact Sciences Corp. (Nasdaq: EXAS) today announced that it has submitted tothe U.S. Food and Drug Administration the final module of the premarketapproval (PMA) application for Cologuard(TM), the company's stool DNA (sDNA)colorectal cancer screening test. The final module, which is comprised ofdata from the company's DeeP-C clinical trial, completes the company's PMAapplication for the product. The DeeP-C trial is one of the most extensive colorectal cancer screeningstudies ever conducted in the United States. It analyzed data fromapproximately 10,000 patients at 90 sites between the ages of 50 and 84 whowere at average risk for colorectal cancer. "The completion of our PMA submission to the FDA is the most significantmilestone in the company's history and a big step forward in helpingphysicians make the battle against colorectal cancer a winning one," saidKevin T. Conroy, the company's president and chief executive. "I want tothank the tremendous team at Exact Sciences and our collaborators for theiroutstanding work. We share a passion for delivering our breakthroughcolorectal cancer screening test to the physicians and patients who need it.Now, we look forward to continuing to work with the FDA through the reviewprocess." 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 brokeninto clearly defined parts or modules. These modules are submittedseparately over time and comprise a complete PMA when all of them have beencompleted. The FDA reviews each module as it is received, which may allowfor more rapid closure of the application. The company will submit the DeeP-C study's pivotal data set for publicationin a peer-reviewed journal, presentation at a major medical meeting or both. The company also announced the expansion of Maneesh K. Arora's chiefoperating officer responsibilities to include the oversight of U.S. salesand marketing. The company is in the process of building out its commercialleadership team and is also conducting a search for a senior financialofficer. "Maneesh is an invaluable partner who has been instrumental in developingthe company's commercial strategy and is the best person to lead asuccessful launch of Cologuard," Mr. Conroy said. About Exact Sciences Corp. Exact Sciences Corp. is a molecular diagnostics company focused on the earlydetection and prevention of colorectal cancer. The company has exclusiveintellectual property protecting its noninvasive, molecular screeningtechnology for the detection of colorectal cancer. Stool-based DNAtechnology is included in the colorectal cancer screening guidelines of theAmerican Cancer Society and the U.S. Multi-Society Task Force on ColorectalCancer. For more information, please visit the company's website atwww.exactsciences.com. Certain statements made in this news release contain forward-lookingstatements 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, asamended, that are intended to be covered by the "safe harbor" created bythose sections. Forward-looking statements, which are based on certainassumptions and describe our future plans, strategies and expectations, cangenerally 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-lookingstatements in this news release may address the following subjects amongothers: statements regarding the sufficiency of our capital resources,expected operating losses, anticipated results and timing of our pivotalclinical trial, expectations concerning our ability to secure FDA approvalof our Cologuard test, expected license fee revenues, expected research anddevelopment expenses, expected general and administrative expenses and ourexpectations concerning our business strategy. Forward-looking statementsinvolve inherent risks and uncertainties which could cause actual results todiffer materially from those in the forward-looking statements, as a resultof various factors including those risks and uncertainties described in theRisk Factors and in Management's Discussion and Analysis of FinancialCondition and Results of Operations sections of our most recently filedAnnual Report on Form 10-K and our subsequently filed Quarterly Reports onForm 10-Q. We urge you to consider those risks and uncertainties inevaluating our forward-looking statements. We caution readers not to placeundue reliance upon any such forward-looking statements, which speak only asof the date made. Except as otherwise required by the federal securitieslaws, we disclaim any obligation or undertaking to publicly release anyupdates or revisions to any forward-looking statement contained herein (orelsewhere) to reflect any change in our expectations with regard thereto orany change in events, conditions or circumstances on which any suchstatement is based.