News Release

<< Back EXACT Sciences' Announces Acceptance of its Medicare Application Seeking Coverage of DNA-based Colorectal Cancer Screening Technology Process for National Coverage Determination Begins MARLBOROUGH, Mass.--(BUSINESS WIRE)--Aug. 2, 2007--EXACT Sciences Corporation (NASDAQ: EXAS) announced today that the Centers for Medicare & Medicaid Services (CMS) has accepted its application requesting a national coverage determination for the Company's DNA-based colorectal cancer (CRC) screening technologies. While there is typically a nine- to twelve-month statutory period from application acceptance to a final CMS coverage determination, CMS has indicated that it expects to complete the national coverage analysis by May 1, 2008. Medicare beneficiaries include 43 million of the approximately 87 million people in the U.S. over age 50 for whom regular screening is recommended. Claims data from 1998-2002 suggest that only about 31 percent of Medicare beneficiaries have ever had a CRC screening test. Moreover, since 69 percent of newly diagnosed cases of CRC occur in people aged 65 and older, Medicare assumes a significant portion of the costs associated with CRC treatment. "Clinical evidence shows that stool-based DNA (sDNA) screening technology is cost-effective, has superior performance over all other non-invasive CRC screening methods and has high patient compliance," said Jeffrey Luber, President of EXACT Sciences Corporation. "Because it is completely non-invasive and does not require a bowel preparation or change in diet or drug schedule, we believe that sDNA technologies can prompt more Medicare beneficiaries to get screened for colon cancer, reduce overall costs to the system associated with treating late stage disease, and help save more lives. We look forward to what we hope will be a positive coverage determination by CMS which is a critical step for widespread adoption of sDNA technologies across the country." The NCA tracking sheet for EXACT's DNA-based colorectal cancer screening technology can be found on the CMS website at: https://www.cms.hhs.gov/mcd/viewtrackingsheet.asp?id=212 Colorectal cancer is the most deadly cancer among non-smoking men and women in the U.S., and the second most deadly cancer overall. Annually, there are nearly 154,000 CRC cases diagnosed and 52,000 deaths due to this disease. It is estimated that roughly one-third of CRC-related deaths could be saved if more people underwent regular screening. Early diagnosis results in a greater than 90 percent, five-year survival rate. ACS and CMS have designated CRC a breakthrough priority. The ACS is collaborating with CMS to help CMS improve CRC screening among the approximately 43 million Medicare beneficiaries. About EXACT Sciences Corporation EXACT Sciences Corporation uses applied genomics to develop effective, patient-friendly screening technologies for use in the detection of cancer. Colorectal cancer, which is the most deadly cancer among non-smokers, is generally curable if detected early. Despite the availability of colorectal cancer screening and diagnostic tests for more than 20 years, the rate of early detection of colorectal cancer remains low, and deaths from colorectal cancer remain high. EXACT Sciences believes its genomics-based technologies will help enable detection of colorectal cancer so that more people can be effectively treated. EXACT Sciences is based in Marlborough, Mass. PreGen-Plus(TM), the non-invasive colorectal cancer screening testing service offered by Laboratory Corporation of America Holdings(R) (LabCorp(R)) has not been approved or cleared by the U.S. Food & Drug Administration. 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, among other things, the ability of EXACT Sciences to realized the expected benefits of a Medicare coverage approval for stool-DNA screening for colorectal cancer, the efficacy of its colorectal cancer screening technology and management's plans, objectives and strategies. 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, the clinical performance and market acceptance of its technologies; the reproducibility of its research results in subsequent studies and in clinical practice; the inclusion of fecal DNA screening in colorectal cancer screening guidelines; 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 of the PreGen-Plus test; the ability of EXACT Sciences or LabCorp to lower the cost of the PreGen-Plus test 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; the possibility that other companies will develop and market novel or improved methods for detecting colorectal cancer; and the ability to raise additional capital on acceptable terms. 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. CONTACT: EXACT Sciences Corporation Jeffrey Luber, 508-683-1211 President SOURCE: EXACT Sciences Corporation back to top