EXACT Sciences Corporation (NASDAQ: EXAS) announced today that the Company has scheduled another meeting with the Centers for Medicare & Medicaid Services (CMS) for January 25, 2008, to further discuss the status of EXACT’s application for a national coverage determination (NCD) on its stool-based DNA colorectal cancer (CRC) screening technology.
EXACT previously announced acceptance of its Medicare application seeking national coverage approval of stool-based DNA screening for CRC on August 2, 2007. In light of the subsequent correspondence with the U.S. Food and Drug Administration (FDA) pertaining to Version 1 of the Company’s technology, EXACT intends to further discuss with CMS the approaches CMS might take to the pending NCD. Appropriate regulatory status is a key precondition for an NCD.
Medicare beneficiaries include 43 million of the approximately 87 million people in the U.S. over age 50 for whom regular screening is recommended. 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. The cost-effectiveness report on stool-based DNA screening for CRC that was recently conducted on behalf of CMS, stated that adherence to CRC screening is an important factor. Recent findings report that 75 percent of Medicare beneficiaries do not follow the CRC screening guidelines as recommended. Based on published studies, the Company believes that its DNA-based screening for colon cancer offers the potential to increase adherence among Medicare beneficiaries, thereby justifying favorable reimbursement in the future.
“We have advised CMS of the status of our discussions with the FDA and, in an effort to preserve our future opportunity for a positive coverage decision, we requested that it consider not proceeding with the NCD until the FDA has acted,” said Jeffrey R. Luber, President of EXACT Sciences. “We look forward to meeting with CMS to better understand its likely approach while we pursue FDA clearance for our DNA-based colorectal cancer screening technology.”
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. The American Cancer Society (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. Certain of its technologies have been licensed to Laboratory Corporation of America Holdings® (LabCorp®) for a stool-based DNA assay developed by LabCorp for colorectal cancer screening in the average-risk population and marketed by LabCorp under the name PreGen-Plus™. 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 earlier detection of colorectal cancer so that more people can be effectively treated. EXACT Sciences is based in Marlborough, Mass. PreGen-Plus, the non-invasive colorectal cancer screening testing service offered by LabCorp, 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, a potential national coverage determination by the Centers for Medicare & Medicaid Services and its strategy related thereto, and potential compliance rates for its colorectal cancer screening technologies. 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 PreGen-Plus in cancer screening guidelines; sufficient investment in the sales and marketing of PreGen-Plus; the success of its strategic relationship with LabCorp; EXACT Sciences' and LabCorp's 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 comply with federal and state statutes and regulations relating to EXACT Sciences' products and services, including FDA requirements, the U.S. Department of Transportation and the Clinical Laboratory Improvement Amendments; 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.
Contacts:
Jeffrey R. Luber, 508-683-1211
President
jluber@exactsciences.com
