1124140--3/17/2008--EXACT_SCIENCES_CORP

related topics
{product, candidate, development}
{product, liability, claim}
{regulation, government, change}
{property, intellectual, protect}
{stock, price, operating}
{product, market, service}
{gas, price, oil}
{personnel, key, retain}
{provision, law, control}
{customer, product, revenue}
{interest, director, officer}
Our independent auditors have expressed substantial doubt about our ability to continue as a going concern, and we may be unable to raise additional capital on acceptable terms in the future. We may never successfully commercialize any of our technologies or become profitable. If we or LabCorp fail to comply with FDA requirements, we or LabCorp may be limited or prohibited in our ability to commercialize stool-based DNA testing for colorectal cancer and may be subject to stringent penalties. Our ability to generate revenue depends on LabCorp's commercial sales of PreGen-Plus and future generations of our technologies. Our business is substantially dependent on the success of our strategic agreement with LabCorp. If Medicare and other third-party payors, including managed care organizations, do not issue positive policy decisions approving reimbursement for PreGen-Plus, the commercial success of PreGen-Plus would be compromised. The lack of a recommended screening interval for stool-based DNA screening in the guidelines of the American Cancer Society and the U.S. Multisociety Task Force on Colorectal Cancer may limit the acceptance of our technologies among physicians and third party payors, including Medicare. Our business would suffer if we, or LabCorp, 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 superiority, reliability, or effectiveness 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 PreGen-Plus. 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. If PreGen-Plus cannot be effectively sold at a price acceptable to the market, the successful commercialization of PreGen-Plus would be materially harmed. If our or LabCorp's technological advancements do not increase the performance of PreGen-Plus in a cost effective manner, the demand for PreGen-Plus may be negatively impacted. If an insufficient number of medical practitioners order and reorder tests using our technologies, our revenue and profitability will be limited. 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. Other companies may develop and market novel or improved methods for detecting colorectal cancer, which may make our technologies less competitive, or even obsolete. We rely on third-party contract manufacturers and suppliers and may experience a scarcity of raw materials and components. 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 loss of key members of our senior management team could adversely affect our business. Our stock price may be volatile. Our operating results may fluctuate, which may adversely affect our share price. 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.

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