1116463--3/12/2008--ORASURE_TECHNOLOGIES

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You should carefully consider the risks and uncertainties described below, together with all of the other information included in this Annual Report and our other SEC filings in considering our business and prospects. The risks and uncertainties described below are not the only ones facing us. Additional risks and uncertainties not disclosed or not presently known to us or that we currently deem immaterial also may impair our business operations. The occurrence of any of the following risks could harm our business, financial condition or results of operations. The Need to Obtain Regulatory Approvals and Respond to Changes in Regulatory Requirements Could Adversely Affect Our Business. The Inability to Extend the Shelf Life of Our OraQuick ADVANCE HIV-1/2 Test Could Adversely Affect Our Business. Failure to Comply With FDA or Other Regulatory Requirements May Require Us to Suspend Production of Our Products or Institute a Recall Which Could Result in Higher Costs and a Loss of Revenues. We Are Subject to Numerous Government Regulations in Addition to FDA Requirements, Which Could Increase Our Costs or Affect Our Operations. Our Ability to Sell Products Could be Affected by Competition From New and Existing Diagnostic Products and by Treatments or Other Non-Diagnostic Products Which May be Developed. Our Research, Development and Commercialization Efforts May Not Succeed and Our Competitors May Develop and Commercialize More Effective or Successful Diagnostic Products. If We Lose Our Key Personnel or Are Unable to Attract and Retain Qualified Personnel as Necessary, Our Business Could be Harmed. Future Acquisitions or Investments Could Disrupt Our Ongoing Business, Distract Our Management, Increase Our Expenses and Adversely Affect Our Business. Our Revenues Could be Affected by Third-Party Reimbursement Policies and Potential Cost Constraints. Increases in Demand for Our Products Could Require Us to Expend Considerable Resources to Meet the Demand or Harm Our Customer Relationships if We are Unable to Meet That Demand. Our Failure to Maintain Existing Distribution Channels, or Develop New Distribution Channels, May Result in Lower Revenues. The Use of Sole Supply Sources or Third Party Suppliers For Critical Components of Our Products Could Adversely Affect Our Business. The Unavailability of Certain Products Distributed by a Third Party Could Adversely Affect Sales of Our OraSure Oral Fluid Collection Device. We May Need Strategic Partners to Assist in Developing and Commercializing Some of Our Diagnostic Products. We Have a History of Losses Prior to 2005. We May Experience Fluctuations in Our Financial Results or Fail to Meet Our Financial Projections. Our Portfolio Investments May Be Subject to Volatility and Uncertainty in the Financial Markets and Other Risks. Accounting for Certain Investments in Debt and Equity Securities Utilization of Our Deferred Tax Assets May Be Limited and is Dependent on Future Taxable Income. If Our Estimates or Judgments Relating to Our Critical Accounting Policies Are Based on Assumptions That Change or Prove to be Incorrect, Our Operating Results Could Fall Below Expectations of Securities Analysts and Investors, Resulting in a Decline in Our Stock Price. Our Credit Facilities Contain Certain Financial Covenants Which, if Not Satisfied, Could Result in the Acceleration of the Amounts Due Under These Facilities and Limit Our Ability to Borrow in the Future. We May Require Future Additional Capital. An Economic Downturn, Terrorist Attacks or National Disasters May Adversely Affect Our Business. Our Stock Price Could Continue to be Volatile. Future Sales of Our Common Stock by Existing Stockholders, Executive Officers or Directors Could Depress the Market Price of Our Common Stock and Make It More Difficult For Us to Sell Stock in the Future. Investor Confidence and Share Value May be Adversely Impacted if We and/or Our Independent Registered Public Accounting Firm Conclude That Our Internal Control Over Financial Reporting is Not Effective. Anti-Takeover Provisions in Our Certificate of Incorporation, Bylaws and Stockholder Rights Plan and Under Delaware Law Could Make a Third Party Acquisition of Us Difficult. Our Success Depends on Our Ability to Protect Our Proprietary Technology. We May Become Involved in Intellectual Property Infringement Disputes, Which are Costly and Could Limit or Eliminate Our Ability to Sell Our Products or Use Certain of Our Technologies in the Future. The Sales Potential for Our OraQuick Products Could be Affected by Our Ability to Obtain Certain Licenses. A Market for Our Products May Not Develop. If Acceptance and Adoption of Our Oral Fluid Testing Does Not Continue, Our Future Results May Suffer. Our Customers May Resist Adoption of Rapid Point-of-Care Diagnostic Testing. Our Sales Cycles Can be Lengthy and May Depend on Public Funding, Which Can Cause Variability and Unpredictability in Our Operating Results. We May be Sued for Product Liabilities for Injuries Resulting From the Use of Our Products. Performance of Our Products May Affect Our Revenues, Stock Price and Reputation. Our Inability to Manufacture Products in Accordance With Applicable Specifications, Performance Standards or Quality Requirements Could Adversely Affect Our Business. Our Increasing International Presence May be Affected by Regulatory, Cultural or Other Restraints.

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1116463--3/12/2008--ORASURE_TECHNOLOGIES_INC