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EXACT Sciences Announces Issuance of Key Patent Covering Vimentin Gene for Colorectal Cancer Screening

Friday, February 06, 2009

Marlborough, MA -- EXACT Sciences Corporation (Nasdaq: EXAS) announced today that a United States patent was issued that covers the use of differentially methylated vimentin as a marker for the detection of colon cancer. The issued patent, expiring in 2024, "Methods and Compositions for Detecting Colon Cancers," United States Patent No. 7,485,420, describes, in part, assays for the detection of methylation within a vimentin nucleotide sequence. Studies have demonstrated that methylation of vimentin DNA is associated with the presence of colorectal cancer. Through its license agreement with Case Western Reserve University, EXACT has exclusive worldwide rights to the vimentin gene technology for non-invasive stool-based detection of colorectal cancer and pre-malignant colorectal polyps.

"We are pleased that the US Patent and Trademark Office has issued this important patent around methylated vimentin, a gene that contributed vastly to the sensitivity for our Version 2 technology in the 2008 Itzkowitz study," said Jeffrey R. Luber, President and Chief Executive Officer of EXACT Sciences. "We have long been focused on building a formidable patent estate around non-invasive colorectal cancer screening, and this latest patent issuance provides additional strength to our broad franchise."

"Witnessing the development from the lab bench to the now issued patent of methylated vimentin testing for colon cancer is extremely gratifying to me as a cancer researcher," commented Sanford Markowitz, MD, PhD, of Case Western Reserve University Department of Medicine, the developer of the technology. "We have long believed in the diagnostic power of methylated vimentin for the non-invasive early detection of colorectal cancer from stool. I believe that a non-invasive test for colorectal cancer based on the vimentin gene marker can lead to early detection and thereby save lives. I am pleased to see today’s patent issuance around this discovery."

About EXACT Sciences Corporation

EXACT Sciences Corporation uses applied genomics to develop patient-friendly screening technologies for use in the detection of cancer. EXACT has established a strategic relationship with Genzyme to, among other things, facilitate the development of the Company’s next-generation stool-based DNA (sDNA) technology. EXACT maintains an exclusive license agreement in the United States and Canada with Laboratory Corporation of America® Holdings (LabCorp®) for certain intellectual property relating to sDNA screening. 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 (a group comprised of representatives from the American College of Gastroenterology, American Gastroenterological Association, and American Society for Gastrointestinal Endoscopy), and the American College of Radiology. EXACT Sciences is based in Marlborough, Mass.

Risk Factors and Forward-Looking Statements

Certain statements made in this press release that are not based on historical information are express or implied forward-looking statements relating to, among other things, EXACT Sciences' expectations concerning the development of EXACT’s colorectal cancer screening technologies and similar matters. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond EXACT Sciences' control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things, EXACT Sciences' ability to secure FDA approval or clearance for any of its products; changes in FDA guidance or policy; the success of EXACT’s strategic relationship with Genzyme; the risks of litigation; the ability to attract prospective collaborators or other parties to enter into a collaboration, acquisition or other strategic transaction with EXACT; the ability to raise additional capital on acceptable terms; the clinical performance and market acceptance of its technologies; the reproducibility of its research results in subsequent studies and in clinical practice; sufficient investment in the sales and marketing of EXACT Sciences' technologies; the success of its strategic relationship with LabCorp; EXACT Sciences' ability to license certain technologies or obtain raw materials for its technologies; the ability to convince Medicare and other third-party payors to provide adequate reimbursement for EXACT Sciences' technologies; the ability to convince medical practitioners to order tests using EXACT Sciences' technologies; the ability to increase the performance its technologies; the ability of EXACT Sciences or LabCorp to lower the cost of stool-based DNA screening technologies through automating and simplifying key operational processes; the number of people who decide to be screened for colorectal cancer using EXACT Sciences' technologies; competition; the ability to protect EXACT Sciences' intellectual property and the cost of enforcing or defending EXACT Sciences in litigation relating to intellectual property rights; and the possibility that other companies will develop and market novel or improved methods for detecting colorectal cancer. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. EXACT Sciences undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional disclosure regarding these and other risks faced by EXACT Sciences, see the disclosure contained in EXACT Sciences' public filings with the Securities and Exchange Commission including, without limitation, its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the SEC.

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