State Mandates For Stool-Based DNA Screening For Colon Cancer Now In Twelve States And The District Of Columbia

Main Category: Colorectal Cancer
Also Included In: Cancer / Oncology
Article Date: 12 Jan 2009 - 3:00 PDT

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EXACT Sciences Corporation (NASDAQ: EXAS) reported that as of January 1, 2009, twelve states and the District of Columbia have legislative mandates requiring that available colorectal cancer (CRC) screening options offered by certain categories of insurers in these states must include all tests identified in the current American Cancer Society (ACS) screening guidelines, which include stool-based DNA (sDNA) screening.

The state of Maine, which enacted a legislative mandate covering colorectal cancer screening effective on January 1, 2009, has become the latest state to explicitly reference CRC screening guidelines, which include sDNA testing. The list now includes Alaska, Georgia, Illinois, Indiana, Kentucky, Maine, Maryland, Missouri, Nevada, New Jersey, North Carolina, Rhode Island and the District of Columbia. An analysis by the American Cancer Society found that screening rates improved forty-percent faster in states with strong reimbursement coverage laws as compared to states without such laws.

"Clearly, we are pleased with the progress with state legislators taking the initiative to mandate coverage for CRC screening and thereby providing standard of care for their constituents," commented David. A. Johnson MD FACG, Professor of Medicine, Chief of Gastroenterology Eastern VA Medical School, Norfolk, Virginia. "States with these mandates have shown superior CRC screening rates and this correlates with decreased mortality from colon cancer. Although progress is noted, there remains the challenge to get the residual states to initiate legislation to provide this coverage for CRC screening. Until we have all states covered, there is work yet to be done."

According to the American Cancer Society, only half of those people 50 years of age and older, the target group for colorectal cancer screening, have received recommended screening tests. The American Cancer Society estimates that, in the United States alone, there were 148,810 new cases of colorectal cancer in 2008.

About Colorectal Cancer

Colorectal cancer is the most deadly cancer among non-smoking men and women in the United States, and the second most deadly cancer overall. 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 remain high. It is estimated that roughly one-third of colorectal cancer-related deaths could be avoided if more people underwent regular screening. Early diagnosis results in a greater than 90 percent, five-year survival rate.

About EXACT Sciences Corporation

EXACT Sciences Corporation uses applied genomics to develop patient-friendly screening technologies for use in the detection of cancer. 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 stool-based DNA screening. EXACT continues to retain rights to offer a colorectal cancer testing service itself within the United States, to develop a U.S. Food and Drug Administration cleared or approved in vitro diagnostic colorectal cancer test kit, and rights to license its colorectal cancer technologies outside of the United States and Canada. 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. The Company has 115 patents in the United States and abroad, with key intellectual property assets applicable to the field of oncology and reproductive health. EXACT Sciences is based in Marlborough, Mass.

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 increasing early detection rates for colorectal cancer, system-wide adoption of sDNA 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 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.

EXACT Sciences Corporation

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