Non-invasive stool-based DNA screening for colon cancer recognized more broadly as standard of care

Dec 16 2008

EXACT Sciences Corporation today commented on the addition of non-invasive stool-based DNA (sDNA) testing to the state colorectal cancer screening mandates of New Jersey and Maryland, as well as the decision by CIGNA, one of the nation's largest insurers, to include sDNA screening among its covered benefits nationally.

Under insurance bulletins issued by the states of New Jersey and Maryland, available colorectal cancer (CRC) screening options offered by certain categories of insurers in these states must include all tests identified in the 2008 American Cancer Society screening guidelines, which include sDNA screening. A May 2006 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.

“We applaud these latest decisions, which provide continued momentum toward making non-invasive sDNA colorectal cancer screening available for the millions of Americans over the age of 50 who have been unwilling or unable to use invasive screening methods for detecting colorectal cancer,” commented Jeffrey R. Luber, EXACT's President and Chief Executive Officer. “Although we do not expect that these decisions alone will have a material impact on revenues or testing volumes based on LabCorp's current reimbursed rates for its sDNA testing service, we are very excited by what this can mean for the long-term potential of sDNA testing. It takes time for new medical technologies to take hold on a national basis. These new policy decisions, as well as the medical society endorsement for sDNA in the colorectal cancer screening guidelines of the American Cancer Society earlier this year, are significant validations of the increasing body of evidence demonstrating the importance of sDNA testing in the battle against colorectal cancer.”

The insurance bulletins and the CIGNA coverage decision can be found at:

• CIGNA coverage policy
• New Jersey bulletin
• Maryland bulletin

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. The American Cancer Society estimates that nearly 150,000 cases will be diagnosed and 50,000 deaths are anticipated in 2008 due to this disease. 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.