1124140--3/12/2010--EXACT_SCIENCES_CORP

related topics
{product, liability, claim}
{product, candidate, development}
{property, intellectual, protect}
{regulation, government, change}
{acquisition, growth, future}
{personnel, key, retain}
{provision, law, control}
{customer, product, revenue}
{stock, price, operating}
We may never successfully commercialize any of our technologies or become profitable. We will need additional capital to execute our business plan, and we may be unable to raise additional capital on acceptable terms. If Medicare and other third-party payors, including managed care organizations, do not issue positive policy decisions approving reimbursement for our stool-based DNA colorectal cancer screening technology, the commercial success of products utilizing our technologies would be compromised. Other companies may develop and market novel or improved methods for detecting colorectal cancer, which may make our technologies less competitive, or even obsolete. Our business would suffer if we are unable to license certain technologies or obtain raw materials and components or if certain of our licenses were terminated. If our clinical studies do not prove the reliability, effectiveness and superiority of stool-based DNA testing, we may experience reluctance or refusal on the part of physicians to order, and third-party payors to pay for, tests based on our technologies. We expect to rely on third parties to conduct any future studies of our technologies that may be required by the FDA, and those third parties may not perform satisfactorily. We may experience limits on our revenue if only a small number of people decide to be screened for colorectal cancer using our technologies. We may be subject to substantial costs and liability or be prevented from licensing our technologies for cancer detection as a result of litigation or other proceedings relating to patent rights. If we are unable to protect our intellectual property effectively, we may be unable to prevent third parties from using our intellectual property, which would impair our competitive advantage. If we or our partners fail to comply with regulatory requirements, we may be subject to stringent penalties and our business may be materially adversely affected. The success of our business and business strategy will be substantially dependent upon the efforts of our senior management team. If we lose the support of our key scientific collaborators, it may be difficult to establish tests using our technologies as a standard of care for colorectal cancer screening, which may limit our revenue growth and profitability. Product liability suits against us could result in expensive and time-consuming litigation, payment of substantial damages and increases in our insurance rates. Certain provisions of our charter, by-laws and Delaware law may make it difficult for you to change our management and may also make a takeover difficult. Our stock price may be volatile.

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