OraSure Technologies

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Registration No. 333-[_____] - -------------------------------------------------------------------------------- SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ------------------------------------------------- FORM S-3 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 ------------------------------------------------- ORASURE TECHNOLOGIES, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 36-4370966 (State or Other (IRS Employer Jurisdiction of Identification Number) Incorporation or Organization) 150 Webster Street Bethlehem, Pennsylvania 18015 (610) 882-1820 (Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant's Principal Executive Offices) Jack E. Jerrett, Esq. Vice President and General Counsel OraSure Technologies, Inc. 150 Webster Street Bethlehem, Pennsylvania 18015 (610) 882-1820 (Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent For Service) COPIES TO: Jeffrey P. Libson, Esq. Steven J. Feder, Esq. Pepper Hamilton LLP 1235 Westlakes Drive, Suite 400 Berwyn, Pennsylvania 19312-2401 (610) 640-7800 APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC: From time to time after the effective date of this Registration Statement. If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box. |_| If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended (the "Securities Act"), other than securities offered only in connection with dividend or interest reinvestment plans, check the following box. |X|

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. |_| If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. |_| If delivery of the prospectus is expected to be made pursuant to Rule 434, please check the following box. |_| CALCULATION OF REGISTRATION FEE =============================================================================== Proposed Maximum Proposed Amount Aggregate Maximum Amount Of Title of Shares To Be Price Aggregate Registration To Be Registered Registered(1) Per Offering Fee Unit(2) Price - ------------------------------------------------------------------------------- Common Stock, $0.000001 par 4,049,882 $11.65 $47,181,125.30 $11,795.30 value including preferred stock purchase rights =============================================================================== (1) Includes an indeterminate number of shares of OraSure Technologies, Inc. common stock that may be issuable by reason of stock splits, stock dividends or similar transactions. (2) The amount is based on the average of the high and low price of OraSure's common stock on The Nasdaq National Market on June 28, 2001 and is used solely for the purpose of calculating the registration fee pursuant to Rule 457(c) under the Securities Act. THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF THE SECURITIES ACT OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(A), MAY DETERMINE.

THE INFORMATION IN THIS PROSPECTUS IS NOT COMPLETE AND MAY BE CHANGED. A REGISTRATION STATEMENT RELATING TO THESE SECURITIES HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. THESE SECURITIES MAY NOT BE SOLD NOR MAY OFFERS TO BUY BE ACCEPTED PRIOR TO THE TIME THE REGISTRATION STATEMENT BECOMES EFFECTIVE. THIS PROSPECTUS SHALL NOT CONSTITUTE AN OFFER TO SELL OR THE SOLICITATION OF AN OFFER TO BUY NOR SHALL THERE BE ANY SALE OF THESE SECURITIES IN ANY STATE IN WHICH SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL PRIOR TO THE REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF ANY SUCH STATE. Subject to Completion, dated July __, 2001 PROSPECTUS [GRAPHIC OMITTED][GRAPHIC OMITTED] 4,049,882 SHARES OF COMMON STOCK This prospectus relates to the resale of common stock that we issued and sold to the selling stockholders listed on page 9. We will not receive any proceeds from the sale of the shares by the selling stockholders. The selling stockholders, or their pledgees, donees, transferees or other successors-in-interest, may offer the common stock through public or private transactions, at prevailing market prices, at prices related to prevailing market prices or at privately negotiated prices. Our common stock is listed on The Nasdaq National Market under the symbol "OSUR." On June 28, 2001 the reported last sale price of our common stock on The Nasdaq National Market was $11.84 per share. Our principal offices are located at 150 Webster Street, Bethlehem, Pennsylvania 18015, and our telephone number is (610) 882-1820. --------------- INVESTING IN OUR COMMON STOCK INVOLVES RISKS. YOU SHOULD CAREFULLY CONSIDER THE "RISK FACTORS" BEGINNING ON PAGE 2 OF THIS PROSPECTUS BEFORE YOU DECIDE TO INVEST. --------------- The Securities and Exchange Commission and state securities regulators have not approved or disapproved these securities, or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense. The date of this prospectus is July __, 2001

TABLE OF CONTENTS ADDITIONAL INFORMATION.......................................................1 RISK FACTORS.................................................................3 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS............................8 WHO WE ARE...................................................................8 USE OF PROCEEDS..............................................................9 SELLING STOCKHOLDERS.........................................................9 PLAN OF DISTRIBUTION........................................................10 LEGAL MATTERS...............................................................12 EXPERTS.....................................................................12 INDEMNIFICATION.............................................................12 You should rely only on the information contained in this prospectus. We have not authorized anyone to provide you with information different from that contained or incorporated by reference in this prospectus. The selling stockholders are offering to sell, and seeking offers to buy, shares of our common stock only in jurisdictions where offers and sales are permitted. The information contained in this prospectus is accurate only as of the date of this prospectus, regardless of the time of delivery of this prospectus or of any sale of common stock. Until [_____________], 2001, all dealers that buy, sell or trade the common stock, whether or not participating in this offering, may be required to deliver a prospectus. This is in addition to the dealers' obligation to deliver a prospectus when acting as underwriters and with respect to their unsold allotments or subscriptions.

ADDITIONAL INFORMATION This prospectus is part of a registration statement we have filed with the Securities and Exchange Commission ("SEC"). This prospectus does not contain all of the information contained in the registration statement or the exhibits to the registration statement. For further information about us, please see the complete registration statement. Summaries of agreements or other documents in this prospectus are not necessarily complete. Please refer to the exhibits to the registration statement for complete copies of these documents. We are subject to the information requirements of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and file reports, proxy statements and other information with the SEC. You may read and copy such reports, proxy statements and other information, including the registration statement and all of its exhibits, at the following SEC public reference rooms: 450 Fifth Street, Seven World Trade Center Citicorp Center N.W. Judiciary Plaza Suite 1300 500 West Madison Street Room 1024 New York, NY 10048 Suite 1400 Washington, D.C. 20549 Chicago, IL 60661 You may obtain information on the operation of the SEC public reference room in Washington, D.C. by calling the SEC at 1-800-SEC-0330. Our SEC filings, including the registration statement of which this prospectus forms a part and the documents incorporated by reference that are listed below, are also available from the SEC's Web site at http://www.sec.gov, which contains reports, proxy and information statements and other information regarding issuers that file electronically. The SEC allows us to "incorporate by reference" into this prospectus certain information that we file with it. This means that we can disclose important information to you by referring you to another document that we filed separately with the SEC. The information incorporated by reference is deemed to be part of this prospectus, except for any information superseded by information in this prospectus. You should read the information incorporated by reference because it is an important part of this prospectus. We incorporate by reference the following documents that we previously filed with the SEC pursuant to the Exchange Act and any future filings we will make with the SEC under Section 13(a), 13(c), 14 or 15(d) of the Exchange Act: 1. Our Annual Report on Form 10-K for our fiscal year ended December 31, 2000. 2. Our Quarterly Report on Form 10-Q for the quarter ended March 31, 2001. 3. Our definitive Proxy Materials for the 2001 Annual Meeting of Stockholders filed on April 30, 2001. 4. Our Current Report on Form 8-K dated March 30, 2001. 5. Our Current Report on Form 8-K dated April 2, 2001. 6. The description of our common stock contained in Exhibit 99 to our Quarterly Report on Form 10-Q for the quarter ended March 31, 2001. 7. The description of rights to purchase preferred shares contained in the Registration Statement on Form 8-A filed with the SEC on June 11, 2001. The documents incorporated by reference in this prospectus that are not delivered with this prospectus may be obtained from us without charge. You may obtain these documents incorporated by reference in this prospectus by telephoning us at (610) 882-1820 or writing us at the following address: Corporate Secretary OraSure Technologies, Inc. 150 Webster Street Bethlehem, Pennsylvania 18015 Our Web site is located at http://www.orasure.com. Information contained in our Web site is not a part of this prospectus. 1

RISK FACTORS You should carefully consider the risks described below before making an investment decision. The risks described below are not the only ones facing our company. Additional risks not presently known to us or that we currently deem immaterial may also impair our business operations. Our business, financial condition or results of operations could be materially adversely affected by any of these risks. The trading price of our common stock could decline due to any of these risks, and you may lose all or part of your investment. This prospectus also contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of certain factors, including the risks faced by us described below and elsewhere in this prospectus. WE FACE INTENSE COMPETITION FROM NEW AND EXISTING DIAGNOSTIC PRODUCTS. The diagnostic industry is focused on the testing of biological specimens in a laboratory or at the point of care and is highly competitive and rapidly changing. Our principal competitors have considerably greater financial, technical, and marketing resources. As new products enter the market, our products may become obsolete or a competitor's products may be more effective or more effectively marketed and sold than ours. If we fail to maintain and enhance our competitive position, our customers may decide to use products developed by competitors which could result in a loss of revenues. OUR RESEARCH AND DEVELOPMENT EFFORTS MAY NOT SUCCEED OR OUR COMPETITORS MAY DEVELOP MORE EFFECTIVE OR SUCCESSFUL DIAGNOSTIC PRODUCTS. In order to remain competitive, we must commit substantial resources each year to research and development. The research and development process generally takes a significant amount of time from inception to commercial product launch. This process is conducted in various stages, and during each stage there is a substantial risk that we will not achieve our goals and will have to abandon a product in which we have invested substantial amounts. We expect to continue to incur significant costs in our research and development activities. Moreover, there can be no assurance that we will succeed in our research and development efforts. If we fail to develop commercially successful products, or if competitors develop more effective products or a greater number of successful new products, customers may decide to use products developed by our competitors, which would result in a loss of revenues. IF ACCEPTANCE AND ADOPTION OF OUR ORAL FLUID TESTING IN THE MARKET DOES NOT CONTINUE, OUR FUTURE RESULTS MAY SUFFER. We have made significant progress in gaining acceptance and adoption of oral fluid testing for HIV in the insurance and public health markets. We also expect that oral fluid testing for drugs of abuse will be accepted and adopted in workplace and criminal justice testing markets. Other markets, particularly the physician market, may resist the adoption of oral fluid testing as a replacement for other testing methods in use today. There can be no assurance that we will be able to expand use of our oral fluid testing products in these or other markets. WE MAY REQUIRE FUTURE ADDITIONAL FUNDING TO STAY IN BUSINESS. Although we have made significant progress in the past toward controlling expenses and increasing product revenue, we have historically depended, to a substantial degree, on capital raised through the sale of our equity securities to fund our operations. Our future liquidity and capital requirements will depend on numerous factors, including the costs and timing of the expansion of our manufacturing capacity, the success of our product development efforts, the costs and timing of expansion of our sales and marketing activities, the extent to which existing and new products gain market acceptance, competing technological and market developments, and the scope and timing of strategic acquisitions. If additional financing is needed, we may seek to raise funds through the sale of our equity securities. There can be no assurance that financing through the sale of our equity securities, or otherwise, will be available on satisfactory terms, if at all. 2

OUR FAILURE TO MAINTAIN EXISTING DISTRIBUTION CHANNELS OR DEVELOP NEW DISTRIBUTION CHANNELS, MAY RESULT IN LOWER REVENUES. We have marketed many of our products by collaborating with diagnostic companies and distributors. For example, our OraSure Western blot confirmatory tests are distributed through Organon Teknika Corporation, and our OraSure oral fluid collection device is distributed to the insurance industry through major insurance testing laboratories. Our sales depend to a substantial degree on our ability to develop product distribution channels and on the marketing abilities of the companies with which we collaborate. There can be no assurance that such companies will continue to be able to distribute our products or that new distribution channels will be available on satisfactory terms. THE SIGNIFICANT TIME NECESSARY FOR REGULATORY APPROVAL OF NEW DIAGNOSTIC PRODUCTS MAY PREVENT OR ADVERSELY DELAY OUR ABILITY TO BRING THESE PRODUCTS TO MARKET. We are subject to strict governmental controls on the development, manufacture, labeling, distribution and marketing of our products. We often must obtain and maintain regulatory approval for a product from a country's national health or drug regulatory agency before our product may be sold in a particular country. The submission of an application to a regulatory authority does not guarantee that it will grant us a license to market the product. Each authority may impose its own requirements and delay or refuse to grant approval, even though our product has been approved in another country. In our principal markets, the approval process for a new product can be complex and lengthy. The time taken to obtain approval varies depending on the nature of the application and may result in the passage of a significant period of time from the date of submission of the application. This time span increases our costs to develop new products and increases the risk that we will not succeed in introducing or selling them. In addition, the European Union has established a requirement that diagnostic medical devices used to test biological specimens must receive regulatory approval known as a CE mark by December 2003. After that date, export to the European community of products without the CE mark will be stopped or delayed until the mark is received. This requirement will affect many of our products. We will not be permitted to sell our products in European countries without a CE mark after December 2003, which could lead to the termination of strategic alliances for sales of those products in Europe. While we intend to apply for CE marks for certain of our existing and future products, and are not aware of any material reason why such approvals will not be granted, there can be no assurance that any CE marks will be received prior to the deadline. EVEN THOUGH WE EXPECT TO BE PROFITABLE IN 2001, WE HAVE A HISTORY OF LOSSES. We have not achieved profitability. We incurred a net loss of approximately $12.7 million and $4.2 million for the years ended December 31, 2000 and 1999, respectively, and as of December 31, 2000, we had an accumulated deficit of approximately $122.4 million. Our limited combined operating history makes it difficult to forecast our future operating results. In order to achieve profitability in the estimated time period, our revenue will have to continue to grow at the estimated rates. Our ability to reach our estimated revenue growth will be dependent upon a number of factors including achieving growth in international markets through our OraQuick rapid HIV test, our ability to create market acceptance for the Intercept drugs of abuse products and our ability to commercially develop, and obtain regulatory approval and create market acceptance for, up-converting phosphor technology ("UPT") and other products in a time frame consistent with our objectives. We have not yet achieved these objectives. In the event that we cannot create a significant commercial market for our OraQuick test, the Intercept and UPT products or our other products, our revenue, and consequently profitability, will be lower than estimated. Even if we achieve profitability, we cannot assure you that we will be able to sustain such profitability in the future. 3

THE FDA MAY REQUIRE US TO SUSPEND PRODUCTION OF OUR PRODUCTS WHICH COULD RESULT IN A LOSS OF REVENUES. We can manufacture and sell many of our products, both in the U.S. and in some cases abroad, only if we comply with regulations of governmental agencies such as the United States Food and Drug Administration ("FDA"). We have implemented quality assurance and other systems that are intended to comply with such applicable regulations. The FDA has issued warning letters and a letter of intent to revoke our license with respect to the serum Western Blot product, stating that we are not in compliance with the FDA's regulations. We have responded to each of these letters. Although we believe that we are addressing all of the points raised by the FDA, the FDA could force us to stop manufacturing products if the FDA concludes that we still remain out of compliance with applicable regulations. In addition, until the FDA agrees that we have resolved all of the points raised in their letters, we may not be able to obtain regulatory clearance certificates needed in certain foreign countries. GOVERNMENT REGULATIONS COULD ADVERSELY AFFECT OUR BUSINESS. Many of our proposed and existing products are subject to regulation by the FDA and other governmental agencies. The process of obtaining required approvals from these agencies varies according to the nature of, and uses for, our specific product and can involve lengthy and detailed laboratory and clinical testing, sampling activities, and other costly, time-consuming procedures. Changes in government regulations could require us to undergo additional trials or procedures, or could make it impractical or impossible for us to market our products for certain uses, in certain markets, or at all. Other changes in government regulations, such as the adoption of the FDA's Quality System Regulation, may not affect our products directly but may, nonetheless, adversely affect our financial condition and results of operations by requiring that we incur the expense of changing or implementing new manufacturing and control procedures. A MARKET FOR OUR PRODUCTS MAY NOT DEVELOP. Our future success will depend, in part, on the market acceptance, and the timing of such acceptance, of our recently introduced products such as the Intercept oral fluid drug test service, the OraQuick rapid oral fluid test, products currently under development such as UPlink and other products using up-converting phosphor technology, and other new products or technologies that may be developed or acquired and introduced in the future. To achieve market acceptance, we must make substantial marketing efforts and spend significant funds to inform potential customers and the public of the benefits of these products. We currently have limited evidence on which to evaluate the market reaction to products that may be developed, and there can be no assurance that any products will meet with market acceptance and fill the market need that is perceived to exist. OUR SUCCESS DEPENDS ON OUR ABILITY TO PROTECT OUR PROPRIETARY TECHNOLOGY. The diagnostics industry places considerable importance on obtaining patent, trademark, and trade secret protection, as well as other intellectual property rights, for new technologies, products and processes. Our success depends, in part, on our ability to develop and maintain a strong intellectual property portfolio of products and technologies both in the United States and in other countries. As appropriate, we intend to file patent applications and obtain patent protection for our proprietary technology. These patent applications and patents will cover, as appropriate, compositions of matter for our products, methods of making those products, methods of using those products, and apparatus relating to the use or manufacture of those products. We will also rely on trade secrets, know-how and continuing technological advancements to protect our proprietary technology. We have entered and will continue to enter into confidentiality agreements with our employees, consultants, advisors and collaborators. However, these parties may not honor these agreements and we may not be able to successfully protect our rights to unpatented trade secrets and know-how. Others may independently develop substantially equivalent proprietary information and techniques or otherwise gain access to our trade secrets and know-how. Many of our scientific and management personnel were previously employed by competing companies. Although we encourage and expect all of these types of employees to abide by any confidentiality agreement with a prior employer, competing companies may allege trade secret violations and similar claims against us. 4

To facilitate development and commercialization of a proprietary technology base, we may need to obtain licenses to patents or other proprietary rights from other parties. If we are unable to obtain these types of licenses, our product development and commercialization efforts may be delayed. We may collaborate with universities and governmental research organizations which, as a result, may acquire part of the rights to any inventions or technical information derived from collaboration with them. We may incur substantial costs in asserting or protecting our intellectual property rights, or in defending suits against us related to intellectual property rights. Disputes regarding intellectual property rights could substantially delay product development or commercialization activities. Disputes regarding intellectual property rights might include state or federal court litigation as well as patent interference, patent reexamination, patent reissue, or trademark opposition proceedings in the United States Patent and Trademark Office. Opposition or revocation proceedings could be instituted in a foreign patent office. An adverse decision in any proceeding regarding intellectual property rights could result in the loss of our rights to a patent, an invention, or trademark. THE SALES POTENTIAL FOR ORAQUICK WILL BE AFFECTED BY OUR ABILITY TO OBTAIN CERTAIN LICENSES. There are several factors that will affect the specific countries in which we will be able to sell our OraQuick rapid HIV test and therefore the overall sales potential of the test. One factor is whether we can arrange a sublicense or distribution agreement related to patents for detection of the HIV-2 virus. HIV-2 is a type of the HIV virus estimated to represent less than 2% of known HIV cases worldwide. Nevertheless, HIV-2 is considered to be an important component in the testing regimen for HIV in many markets. HIV-2 patents are in force in most of the countries of North America and Western Europe, as well as in Japan, Korea, South Africa and Australia. Access to a license for one or more HIV-2 patents may be necessary to sell HIV-2 tests in countries where such patents are in force, or to manufacture in countries where such patents are in force and then sell into non-patent markets. Since HIV-2 patents are in force in the U.S., we may be restricted from manufacturing our OraQuick rapid HIV test in the U.S. and selling into other countries, even if there were no HIV-2 patents in those other countries. The importance of HIV-2 differs by country, and can be affected by both regulatory requirements and by competitive pressures. In most countries, any product used to screen the blood supply will require the ability to detect HIV-2, although the OraQuick rapid HIV test has not been intended for that market purpose. In other markets, including the U.S., a test that can detect only the more prevalent HIV-1 type is generally considered sufficient, except in testing related to blood supply. Because the competitive situation in each country will be affected by the availability of other testing products as well as the country's regulatory environment, we may be at a competitive disadvantage in some markets without an HIV-2 product even if HIV-2 detection is not required by regulations. Another factor that may affect the specific countries in which we will be able to sell our OraQuick rapid HIV test, and therefore the overall sales potential, concerns whether we can arrange a sublicense or distribution agreement related to any patents which claim lateral flow assay methods and devices covering the OraQuick rapid HIV test or its use. The OraQuick rapid HIV test is an analyte-specific lateral flow assay device. There are numerous patents in the U.S. and other countries which claim lateral flow assay methods and devices that are analyte independent. Some of these patents broadly cover the type of technology used in the OraQuick assay and are in force in the U.S and other countries. We may not be able to make the OraQuick rapid HIV test in the U.S. and sell it in countries where there is no patent on the device. We have licenses under several lateral flow patents and are considering the need for licenses under others. In the event that it is not possible to negotiate a license or other agreement under a necessary patent, we may be able to modify the OraQuick rapid HIV test such that a license would not be necessary. However, this alternative could delay introduction of the OraQuick rapid HIV test into the U.S. and other markets. IF WE LOSE OUR KEY PERSONNEL OR ARE UNABLE TO ATTRACT AND RETAIN QUALIFIED PERSONNEL AS NECESSARY, OUR DIAGNOSTIC PRODUCT DEVELOPMENT PROGRAMS COULD BE DELAYED OR HARMED. Our success will depend to a large extent upon the contributions of our executive officers, management, and scientific staff. We may not be able to attract or retain qualified employees in the future due to the intense competition for qualified personnel among medical products businesses. If we are not able to attract and retain the necessary personnel to accomplish our business objectives, we may experience constraints that will adversely affect 5

our ability to meet the demands of our strategic partners in a timely fashion or to support internal research and development programs. In particular, product development programs depend on the ability to attract and retain highly skilled scientists, including molecular biologists, biochemists and engineers. Recruiting qualified personnel can be an intensely competitive and time-consuming process. Although we believe we will be successful in attracting and retaining qualified personnel, competition for experienced scientists and other technical personnel from numerous companies and academic and other research institutions may limit our ability to do so on acceptable terms. All of our employees, other than a few senior officers who have employment agreements, are at-will employees, which means that either the employee or we may terminate their employment at any time. If we experience difficulty in recruiting and retaining qualified personnel, and in particular scientific personnel, we may need to provide higher compensation to such personnel than currently anticipated or we may incur additional expenses for the recruitment of qualified personnel. Our business plans will require additional expertise in specific industries and areas applicable to the development efforts related to up-converting phosphor technologies. These activities will require the addition of new personnel, including management, and the development of additional expertise by existing management personnel. The inability to acquire these services or to develop this expertise could impair the development, if any, of products related to this technology. OUR INCREASING INTERNATIONAL PRESENCE MAY BE AFFECTED BY REGULATORY, CULTURAL OR OTHER RESTRAINTS. We intend to devote significant resources to increase international sales of our OraQuick and UPT products. However, in the past, we have not had significant direct experience with the governmental regulatory agencies in foreign countries that control sale of products into those countries. Compliance with foreign regulatory requirements can be difficult and can impede international marketing efforts. In addition to economic and political issues, a number of factors can slow or prevent international sales, or substantially increase the cost of international sales, including those set forth below: o Regulatory requirements (including compliance with applicable customs regulations) may slow, limit, or prevent the offering of products in foreign jurisdictions; o Cultural and political differences may make it difficult to effectively market, sell and gain acceptance of products in foreign jurisdictions; o Inexperience in international markets may slow or limit our ability to sell products in foreign countries; o Exchange rates, currency fluctuations, tariffs and other barriers, extended payment terms and dependence on and difficulties in managing international distributors or representatives may affect our revenues even when product sales occur; and o The credit-worthiness of foreign entities may be less certain and accounts receivable collection may be more difficult. We recently entered into a contract for the manufacture and supply of the OraQuick HIV device in Thailand. However, we do not have significant direct experience with the use of international manufacturers. Factors such as economic and political conditions and foreign regulatory requirements may slow or prevent the manufacture of our products in countries other than the United States. Interruption of the supply of our products could reduce revenues or cause us to incur significant additional expense in finding an alternative source of supply. WE MAY BE SUED FOR PRODUCT LIABILITIES FOR INJURIES RESULTING FROM THE USE OF OUR DIAGNOSTIC PRODUCTS. We may be held liable if any of our products, or any product which is made with the use or incorporation of any of our technologies, causes injury of any type or is found otherwise unsuitable during product testing, manufacturing, marketing or sale. Although we have obtained product liability insurance, this insurance may not fully cover potential liabilities. As new products come to market, we may need to increase our product liability coverage. Inability to obtain sufficient insurance coverage at an acceptable cost or otherwise to protect against potential product liability claims could affect our decision to commercialize products that we develop independently 6

or with our strategic partners. If we are sued for any injury caused by our products, our liability could exceed our policy limits. WE MAY NOT BE ABLE TO COMMERCIALIZE OUR UPT PRODUCTS WHICH COULD NEGATIVELY AFFECT OUR FUTURE REVENUES. Our up-converting phosphor technology is new and is in the early stage of development. Commercial development of UPT may not be successful. Successful products require significant development and investment, including testing, to demonstrate their cost-effectiveness or other benefits prior to their commercialization. In addition, regulatory approval must be obtained before most products based upon UPT may be sold. Additional development efforts on these products will be required before any regulatory authority will review them. Regulatory authorities may not approve these products for commercial sale. Accordingly, because of these uncertainties, products based upon UPT may not be commercialized. The failure to develop UPT products with commercial potential would negatively affect our future revenues. WE ARE DEPENDENT UPON STRATEGIC PARTNERS TO ASSIST IN DEVELOPING AND COMMERCIALIZING SOME OF OUR DIAGNOSTIC PRODUCTS. Although we intend to pursue some product opportunities independently, opportunities that require a level of investment for development and commercialization may necessitate involving one or more strategic partners. In particular, our strategy for development and commercialization of UPT and certain other products may entail entering into additional arrangements with corporate partners, universities, research laboratory licensees, and others. If we are not able to enter into such arrangements, we may be required to transfer material rights to such strategic partners, licensees, and others. While we expect that our current and future partners, licensees, and others have and will have an economic motivation to succeed in performing their contractual responsibilities, the amount and timing of resources to be devoted to these activities will be controlled by others. Consequently, there can be no assurance that any revenues or profits will be derived from such arrangements. WE ARE DEPENDENT UPON PATENTS, LICENSES AND OTHER PROPRIETARY RIGHTS FROM THIRD PARTIES, INCLUDING RIGHTS TO UP-CONVERTING PHOSPHOR COMPOSITIONS, METHODS AND APPARATUSES. We have licensed the worldwide rights to up-converting phosphor compositions, methods, and apparatuses for use in diagnostic applications, which are the subject of seven issued U.S. patents, and of one pending U.S. patent application. Corresponding patents and patent applications have been granted or issued in numerous foreign countries, including, for example, European countries, Japan, and Canada. We cooperate with the licensor to prosecute such patent applications and protect such patent rights. If the licensors do not meet their obligations under the license agreements or do not reasonably consent to sublicenses by us, or if the license agreement is terminated, we could lose the opportunity to develop the up-converting phosphor technology. SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS Because we want to provide you with more meaningful and useful information, this prospectus contains, and incorporates by reference, certain forward-looking statements that reflect our current expectations regarding our future results of operations, performance and achievements. We have tried, wherever possible, to identify these forward-looking statements by using words such as "anticipates," "believes," "estimates," "expects," "plans," "intends," "may," "will," "should," "could" and similar expressions. These statements reflect our current beliefs and are based on information currently available to us. Accordingly, these statements are subject to certain risks, uncertainties and contingencies, including the factors set forth under the caption "Risk Factors," which could cause our actual results, performance or achievements for 2001 and beyond to differ materially from those expressed in, or implied by, any of these statements. You should not place undue reliance on any forward-looking statements. Except as otherwise required by federal securities laws, we undertake no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this prospectus or to reflect the occurrence of unanticipated events. WHO WE ARE We develop, manufacture and market oral fluid specimen collection devices using our proprietary oral fluid technologies, proprietary diagnostic products including in vitro diagnostic tests, and other medical devices. These 7

products are sold in the United States and certain foreign countries to public and private-sector clients, clinical laboratories, physician offices, and hospitals, and for workplace testing. Our business focuses on the following principal platform technologies: (1) the OraSure(R) oral fluid collection device, (2) the OraQuick(R) rapid diagnostics test device, and (3) the new up-converting phosphor technology, or UPT(TM), including its first application, UPlink(TM), a lateral flow testing system for various analytes. In addition, the Company sells certain other products, including the Histofreezer(R) cryosurgical system, certain immunoassay tests and reagents for insurance risk assessment and forensic toxicology applications, an oral fluid Western Blot confirmatory test for HIV-1, and the Q.E.D.(R) Saliva Alcohol Test. Our company was formed in May 2000 under Delaware law solely for the purposes of combining two companies, STC Technologies, Inc. and Epitope, Inc., and changing the state of incorporation of Epitope from Oregon to Delaware. STC Technologies and Epitope were merged into our company on September 29, 2000. Our principal offices are located at 150 Webster Street, Bethlehem, Pennsylvania 18015, and our telephone number is (610) 882 -1820. The merger is expected to leverage our expertise in oral fluid technology, infectious disease testing and substance abuse testing. By building upon the complementary product portfolios, technologies and sales infrastructures of Epitope and STC Technologies, we intend to open up new markets in the United States and other countries and strengthen our position in key markets such as the rapidly expanding point-of-care market. In particular, the proprietary up-converting phosphor technology has broad applications for oral fluid testing. With the increased sensitivity and accuracy of this technology, we believe we can continue to expand the menu of tests available for oral fluid point-of-care testing. This same basic technology is also expected to be of significant benefit to other medical diagnostic manufacturers outside the expertise contributed by Epitope and STC Technologies. For many of these additional applications, we plan to license these to other companies to provide an ongoing revenue stream of research and development, product supply and license fees and royalties. USE OF PROCEEDS We will not receive any proceeds from the sale by the selling stockholders of our common stock. The selling stockholders will receive all of the net proceeds from the sale of the shares. SELLING STOCKHOLDERS Each of the selling stockholders was a stockholder of STC Technologies, Inc. We issued an aggregate of 4,049,882 shares of common stock to the selling stockholders in the merger of STC Technologies, Inc. and Epitope, Inc. into our company on September 29, 2000. Mr. William W. Crouse, a member of our board of directors, is a general partner of HealthCare Partners V, L.P., the general partner of HealthCare Ventures V, L.P. Mr. Crouse has been a member of the board since September 29, 2000 and previously was a member of the board of directors of STC Technologies, Inc. since April 1999. Mr. Michael G. Bolton, a member of our board of directors, is the managing director of Pennsylvania Early Stage Partners GP, LLC, the general partner of Pennsylvania Early Stage Partners, L.P. Mr. Bolton has been a member of the board since September 29, 2000 and previously was a member of the board of directors of STC Technologies, Inc. since April 1999. Messrs. Crouse and Bolton were designated as directors pursuant to the Agreement and Plan of Merger dated May 6, 2000 between STC Technologies and Epitope. The shares listed under the column "Number of Shares Being Offered" in the table below represent the number of shares that may be sold by each selling stockholder pursuant to this prospectus. Pursuant to Rule 416 under the Securities Act, the registration statement of which this prospectus is a part also covers any additional shares of our common stock which become issuable in connection with such shares because of any stock dividend, stock split, recapitalization or other similar transaction effected without the receipt of consideration which results in an increase in the number of outstanding shares of our common stock. We do not know when or in what amounts the selling stockholders may offer shares for sale. The selling stockholders may not sell all or any of the shares offered by this prospectus. The selling stockholders may distribute the shares, from time to time, to one or more of its respective limited and/or general partners, who may sell shares 8

pursuant to this prospectus. We may amend or supplement this prospectus from time to time to update the disclosure set forth herein. Because the selling stockholders may from time to time offer all or some of the shares pursuant to this offering, and because there are currently no agreements, arrangements or understandings with respect to the sale of any of the shares that will be held by the selling stockholders after completion of the offering, we cannot estimate the number of the shares that will be held by the selling stockholders after completion of the offering. However, for purposes of the table below, we have assumed that, after completion of the offering, none of the shares covered by this prospectus will be held by the selling stockholders. The following table sets forth, to our knowledge, certain information regarding the beneficial ownership of the shares of common stock by the selling stockholders as of June 29, 2001. We prepared this table based on the information supplied to us by the selling stockholders named in the table. Beneficial ownership is calculated based upon SEC requirements and is not necessarily indicative of beneficial ownership for any other purpose. The table is based on 36,920,151 shares of our common stock outstanding as of June 29, 2001: Shares Shares Beneficially Owned Beneficially Owned Prior to Offering After Offering ----------------- Number of -------------- Shares Name of Selling Stockholders(1) Number Percentage Being Offered Number Percent - ------------------------------ ------ ---------- ------------- ------ ------- Healthcare Ventures V, L.P. 3,115,292 8.4% 3,115,292 0 - 44 Nassau Street Princeton, New Jersey 08542 Pennsylvania Early Stage 934,590 2.5% 934,590 0 - Partners, L.P. Building 500, Suite 510 435 Devon Park Drive Wayne, Pennsylvania 19087 ------------------------ (1) Includes partners, donees, transferees, pledgees and other successors-in-interest selling shares that are received from a named selling stockholder. PLAN OF DISTRIBUTION The shares covered by this prospectus may be offered and sold from time to time by the selling stockholders. The term "selling stockholders" includes partners, pledgees, donees, transferees or other successors-in-interest selling shares received after the date of this prospectus from the selling stockholders as a pledge, gift, partnership distribution or other non-sale related transfer. To the extent required, we may amend and supplement this prospectus from time to time to describe a specific plan of distribution. The selling stockholders will act independently of us in making decisions with respect to the timing, manner and size of each sale. The selling stockholders may make these sales at prices and under terms then prevailing or at prices related to the then current market price. The selling stockholders may also make sales in negotiated transactions, including pursuant to one or more of the following methods: - purchases by a broker-dealer as principal and resale by such broker-dealer for its own account pursuant to this prospectus; - ordinary brokerage transactions and transactions in which the broker solicits purchasers; - one or more block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction; - an over-the-counter distribution in accordance with the rules of The Nasdaq National Market; and - in privately negotiated transactions. 9

In connection with distributions of the shares or otherwise, the selling stockholders may: - enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the shares in the course of hedging the positions they assume; - sell the shares short and redeliver the shares to close out such short positions; - enter into option or other transactions with broker-dealers or other financial institutions which require the delivery to them of shares offered by this prospectus, which they may in turn resell; and - pledge shares to a broker-dealer or other financial institution, which, upon a default, they may in turn resell. In addition, the selling stockholders may sell all or a portion of the shares that qualify for sale pursuant to Rule 144 and 145 of the Securities Act, as amended, under Rule 144 or 145 rather than pursuant to this prospectus. Sales through brokers may be made by any method of trading authorized by any stock exchange or market on which the shares may be listed or quoted, including block trading in negotiated transactions. Without limiting the foregoing, such brokers may act as dealers by purchasing any or all of the shares covered by this prospectus, either as agents for others or as principals for their own accounts, and reselling such shares pursuant to this prospectus. The selling stockholders may effect such transactions directly, or indirectly through underwriters, broker-dealers or agents acting on their behalf. In effecting sales, broker-dealers or agents engaged by the selling stockholders may arrange for other broker-dealers to participate. Broker-dealers or agents may receive commissions, discounts or concessions from the selling stockholders, in amounts to be negotiated immediately prior to the sale. In offering the shares covered by this prospectus, the selling stockholders, and any broker-dealers and any other participating broker-dealers who execute sales for the selling stockholders, may be deemed to be "underwriters" within the meaning of the Securities Act in connection with these sales. Any profits realized by the selling stockholders and the compensation of such broker-dealers may be deemed to be underwriting discounts and commissions. In order to comply with the securities laws of certain states, the shares must be sold in those states only through registered or licensed brokers or dealers. In addition, in certain states the shares may not be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and is complied with. We have advised the selling stockholders that the anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of shares in the market and to the activities of the selling stockholders and their affiliates. In addition, we will make copies of this prospectus available to the selling stockholders for the purpose of satisfying the prospectus delivery requirements of the Securities Act. The selling stockholders may indemnify any broker-dealer that participates in transactions involving the sale of the shares against certain liabilities, including liabilities arising under the Securities Act. At the time a particular offer of shares is made, if required, we will distribute a prospectus supplement that will set forth: - the number of shares being offered; - the terms of the offering, including the name of any underwriter, dealer or agent; - the purchase price paid by any underwriter; - any discount, commission and other underwriter compensation; - any discount, commission or concession allowed or reallowed or paid to any dealer; and - the proposed selling price to the public. 10

We have agreed to indemnify the selling stockholders against certain liabilities, including certain liabilities under the Securities Act. We have agreed with the selling stockholders to keep the registration statement of which this prospectus constitutes a part effective until the earlier of (i) such time as all of the shares covered by this prospectus have been disposed of pursuant to the registration statement, or (ii) the second anniversary of the effective date of this prospectus, plus any periods during which the selling stockholders were not permitted to sell the shares covered by this prospectus. All costs, expenses and fees in connection with the registration of the shares offered hereby will be borne by us. Brokerage commissions and similar selling expenses, if any, attributable to the sale of shares will be borne by the selling stockholders. LEGAL MATTERS The validity of the shares of our common stock offered by this prospectus will be passed upon for us by Pepper Hamilton LLP, Philadelphia, Pennsylvania. EXPERTS The audited annual financial statements incorporated into this prospectus by reference to our annual report on Form 10-K for the year ended December 31, 2000 have been audited by Arthur Andersen LLP, independent public accountants, as indicated in their report with respect thereto, and are included herein in reliance upon the authority of said firm as experts in giving said report. The financial statements of Epitope, Inc. as of December 31, 1999 and for the three months ended December 31, 1999 and each of the two years in the period ended September 30, 1999, incorporated into this prospectus by reference to OraSure Technologies, Inc.'s Annual Report on Form 10-K for the year ended December 31, 2000 have been so incorporated in reliance on the report from PricewaterhouseCoopers LLP, independent accountants, given on the authority of said firm as experts in auditing and accounting. INDEMNIFICATION Delaware law authorizes a corporation to limit or eliminate the personal liability of its directors for monetary damages for breach of a director's fiduciary duty of care. Delaware law further enables corporations to limit available relief to equitable remedies such as injunction or rescission. Absent the limitations authorized by Delaware law, directors are accountable for monetary damages for conduct constituting gross negligence in the exercise of their duty of care. Our Certificate of Incorporation limits the liability of our directors to the fullest extent permitted by Delaware law. Accordingly, our directors will not be personally liable to us or our stockholders for monetary damages for breach of a fiduciary duty as a director, except for liability for breach of the duty of loyalty, for acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law, for unlawful payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174 of the General Corporation Law of the State of Delaware, or for any transaction in which a director has derived an improper personal benefit. Our Bylaws require us to indemnify to the fullest extent permitted by Delaware law any person who is a party or is threatened to be made a party to any action, suit or proceeding by reason of the fact that such person is or was our director, officer, employee or agent, or is serving as a director, officer, employee or agent of another enterprise at our request. Indemnification is not, however, permitted under the Bylaws unless the person acted in good faith and in a manner that such person reasonably believed to be in or not opposed to our best interests and, with respect to any criminal action or proceeding, that such person had no reasonable cause to believe such person's conduct was unlawful. The Bylaws further provide that we shall not indemnify any person for any liabilities or expenses incurred by such person in connection with an action, suit or proceeding by or in the right of OraSure 11

Technologies in respect of any claim, issue or matter as to which such person shall have been adjudged to be liable to us, unless and only to the extent that the court in which the action, suit or proceeding is brought determines that the person is entitled to indemnity for such expenses. The indemnification provided by the Bylaws is not exclusive of any other rights to which those seeking indemnification may be otherwise entitled. We have entered into indemnification agreements with certain of our directors and officers. The indemnification agreements provide that we will indemnify these directors and officers against all liabilities and expenses actually and reasonably incurred in connection with any action, suit or proceeding (including an action by or in the right of OraSure Technologies) to which any of them is, was or at any time becomes a party, or is threatened to be made a party, by reason of their status as a director or officer, or by reason of their serving or having served at the request or on behalf of OraSure Technologies as a director, officer, trustee or in any other comparable position of any other enterprise to the fullest extent allowed by law. No indemnity will be provided under the indemnification agreements for any amounts for which indemnity is provided by any other indemnification obligation or insurance maintained by us or otherwise. Indemnity will not be available to any director or officer on account of conduct which is finally adjudged by a court to have been knowingly fraudulent, deliberately dishonest or willful misconduct. No indemnification will be provided if a final court adjudication determines that such indemnification is not lawful, or in respect of any suit in which judgment is rendered against any director or officer for an accounting of profits made from a purchase or sale of securities of OraSure Technologies in violation of Section 16(b) of the Exchange Act or of any similar law, or on account of any remuneration paid to any director or officer which is adjudicated to have been paid in violation of law. We have also obtained director's and officer's liability insurance. 12

Part II Information Not Required In Prospectus Item 14. Other Expenses of Issuance and Distribution The following table sets forth the various expenses in connection with the sale and distribution of the securities being registered. All of the amounts shown are estimates except the SEC registration fee. SEC registration fee............................................$11,795.30 Printing and EDGAR filing fees ...................................5,000.00 Legal fees and expenses...........................................5,000.00 Accounting fees and expenses .....................................3,000.00 Miscellaneous fees and expenses ..................................5,000.00 TOTAL ...................................................$29,795.30 Item 15. Indemnification of Directors and Officers Delaware law authorizes a corporation to limit or eliminate the personal liability of its directors for monetary damages for breach of a director's fiduciary duty of care. Delaware law further enables corporations to limit available relief to equitable remedies such as injunction or rescission. Absent the limitations authorized by Delaware law, directors are accountable for monetary damages for conduct constituting gross negligence in the exercise of their duty of care. Our Certificate of Incorporation limits the liability of our directors to the fullest extent permitted by Delaware law. Accordingly, our directors will not be personally liable to us or our stockholders for monetary damages for breach of a fiduciary duty as a director, except for liability for breach of the duty of loyalty, for acts or omissions not in good faith or that involve intentional misconduct or a knowing violation of law, for unlawful payments of dividends or unlawful stock repurchases or redemptions as provided in Section 174 of the General Corporation Law of the State of Delaware, or for any transaction in which a director has derived an improper personal benefit. Our Bylaws require us to indemnify to the fullest extent permitted by Delaware law any person who is a party or is threatened to be made a party to any action, suit or proceeding by reason of the fact that such person is or was our director, officer, employee or agent, or is serving as a director, officer, employee or agent of another enterprise at our request. Indemnification is not, however, permitted under the Bylaws unless the person acted in good faith and in a manner that such person reasonably believed to be in or not opposed to our best interests and, with respect to any criminal action or proceeding, that such person had no reasonable cause to believe such person's conduct was unlawful. The Bylaws further provide that we shall not indemnify any person for any liabilities or expenses incurred by such person in connection with an action, suit or proceeding by or in the right of OraSure Technologies in respect of any claim, issue or matter as to which such person shall have been adjudged to be liable to us, unless and only to the extent that the court in which the action, suit or proceeding is brought determines that the person is entitled to indemnity for such expenses. The indemnification provided by the Bylaws is not exclusive of any other rights to which those seeking indemnification may be otherwise entitled. We have entered into indemnification agreements with certain of our directors and officers. The indemnification agreements provide that we will indemnify these directors and officers against all liabilities and expenses actually and reasonably incurred in connection with any action, suit or proceeding (including an action by or in the right of OraSure Technologies) to which any of them is, was or at any time becomes a party, or is threatened to be made a party, by reason of their status as a director or officer, or by reason of their serving or having served at the request or on behalf of OraSure Technologies as a director, officer, trustee or in any other comparable position of any other enterprise to the fullest extent allowed by law. No indemnity will be provided under the indemnification agreements for any amounts for which indemnity is provided by any other indemnification obligation or insurance maintained by us or otherwise. Indemnity will not be available to any director or officer on account of conduct which is finally adjudged by a court to have been knowingly fraudulent, II-I

deliberately dishonest or willful misconduct. No indemnification will be provided if a final court adjudication determines that such indemnification is not lawful, or in respect of any suit in which judgment is rendered against any director or officer for an accounting of profits made from a purchase or sale of securities of OraSure Technologies in violation of Section 16(b) of the Exchange Act or of any similar law, or on account of any remuneration paid to any director or officer which is adjudicated to have been paid in violation of law. We have also obtained director's and officer's liability insurance. Item 16. List of Exhibits The exhibits filed as part of this registration statement are as follows: Exhibit Description - ----------- ------------------------------------------------------------------ 4.1 Specimen certificate representing shares of OraSure Technologies $.000001 par value Common Stock is incorporated by reference to Exhibit 4.1 to the Registrant's Registration Statement on Form S-4 (No. 333-39210). 4.2 Rights Agreement dated as of May 6, 2000 between OraSure Technologies and ChaseMellon Shareholder Service, L.L.C., as Rights Agent, is incorporated by reference to Exhibit 4.2 to the Registrant's Registration Statement on Form S-4 (No. 333-39210). 4.3 Stockholders Agreement among STC Technologies, Inc., HealthCare Ventures V, L.P., RHO Management Trust II, Hudson Trust and Pennsylvania Early Stage Partners, L.P., dated March 30, 1999, is incorporated by reference to Exhibit 4.3 to the Registrant's Registration Statement on Form S-4 (No. 333-39210). 4.4 Amendment to Stockholders Agreement filed as Exhibit 4.3 is incorporated by reference to Exhibit 4.4 to the Registrant's Registration Statement on Form S-4 (No. 333-39210). 4.5* Second Amendment to Stockholders Agreement dated as of June 29, 2001. 5.1* Opinion of Pepper Hamilton LLP regarding legality of securities being registered. 23.1* Consent of Arthur Andersen LLP. 23.2* Consent of PricewaterhouseCoopers LLP, Independent Accountants. 23.3* Consent of Pepper Hamilton LLP (included in its Opinion filed as Exhibit 5.1 hereto). 24.1* Powers of Attorney (included on signature page). * Filed herewith. Item 17. Undertakings The undersigned registrant hereby undertakes: (1) To file, during any period in which offers or sales are being made, a post-effective amendment to this Registration Statement: (i) To include any prospectus required by Section 10(a)(3) of the Securities Act; (ii) To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in the Registration Statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the "Calculation of Registration Fee" table in the effective registration statement; and II-2

(iii) To include any material information with respect to the plan of distribution not previously disclosed in the Registration Statement or any material change to such information in the Registration Statement; provided, however, that paragraphs (i) and (ii) above do not apply if the Registration Statement is on Form S-3 or Form S-8 and the information required to be included in a post-effective amendment by those paragraphs is contained in periodic reports filed with or furnished to the Commission by the Registrant pursuant to Section 13 or Section 15(d) of the Exchange Act that are incorporated by reference in the Registration Statement. (2) That, for the purpose of determining any liability under the Securities Act, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. (3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering. The undersigned Registrant hereby undertakes that, for purposes of determining any liability under the Securities Act, each filing of the Registrant's annual report pursuant to Section 13(a) or Section 15(d) of the Exchange Act that is incorporated by reference in the Registration Statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions or otherwise, the Registrant has been advised that in the opinion of the SEC such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question of whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue. II-3

SIGNATURES Pursuant to the requirements of the Securities Act of 1933, as amended, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in Bethlehem, Pennsylvania on June 29, 2001. OraSure Technologies, Inc. By: /s/ Robert D. Thompson ------------------------------- Robert D. Thompson Chief Executive Officer POWER OF ATTORNEY Pursuant to the requirements of the Securities Act of 1933, as amended (the "Securities Act"), this Registration Statement has been signed below by the following persons in the capacities and on the dates indicated. Each person whose signature appears below in so signing also makes, constitutes and appoints Robert D. Thompson and Richard D. Hooper, and each of them acting alone, his true and lawful attorney-in-fact and agent, with full power of substitution and resubstitution, for him and in his name, place and stead, in any and all capacities, to execute and cause to be filed with the Securities and Exchange Commission any and all amendments and post-effective amendments to this Registration Statement and a related registration statement that is to be effective upon filing pursuant to Rule 462(b) under the Securities Act, and in each case to file the same, with all exhibits thereto and other documents in connection therewith, and hereby ratifies and confirms all that said attorney-in-fact or his substitute or substitutes may do or cause to be done by virtue hereof. Pursuant to the requirements of the Securities Act, this registration statement has been signed by the following persons in the capacities and on the dates indicated. Signature Title Date - ---------------------------- -------------------------------- ---------- /s/ Robert D. Thompson Chief Executive Officer and June 29, 2001 - ---------------------- Director (Principal Executive Officer) /s/ Richard D. Hooper Vice President of Finance and June 29, 2001 - --------------------- Chief Financial Officer (Principal Financial Officer) /s/ Mark L. Kuna Controller June 29, 2001 - ------------------ (Principal Accounting Officer) /s/ Michael J. Gausling President, Chief Operating June 29, 2001 - ----------------------- Officer and Director /s/ Michael G. Bolton Director June 29, 2001 - --------------------- /s/ William W. Crouse Director June 29, 2001 - --------------------- /s/ Frank G. Hausmann Director June 29, 2001 - --------------------- /s/ Roger L. Pringle Director June 29, 2001 - -------------------- /s/ Gregory B. Lawless Director June 29, 2001 - ---------------------- II-4

Exhibit Index Exhibit Description - ----------- ------------------------------------------------------------------ 4.1 Specimen certificate representing shares of OraSure Technologies $.000001 par value Common Stock is incorporated by reference to Exhibit 4.1 to the Registrant's Registration Statement on Form S-4 (No. 333-39210). 4.2 Rights Agreement dated as of May 6, 2000 between OraSure Technologies and ChaseMellon Shareholder Service, L.L.C., as Rights Agent, is incorporated by reference to Exhibit 4.2 to the Registrant's Registration Statement on Form S-4 (No. 333-39210). 4.3 Stockholders Agreement among STC Technologies, Inc., HealthCare Ventures V, L.P., RHO Management Trust II, Hudson Trust and Pennsylvania Early Stage Partners, L.P., dated March 30, 1999, is incorporated by reference to Exhibit 4.3 to the Registrant's Registration Statement on Form S-4 (No. 333-39210). 4.4 Amendment to Stockholders Agreement filed as Exhibit 4.3 is incorporated by reference to Exhibit 4.4 to the Registrant's Registration Statement on Form S-4 (No. 333-39210). 4.5* Second Amendment to Stockholders Agreement dated June 29, 2001. 5.1* Opinion of Pepper Hamilton LLP regarding legality of securities being registered. 23.1* Consent of Arthur Andersen LLP. 23.2* Consent of PricewaterhouseCoopers LLP, Independent Accountants. 23.3* Consent of Pepper Hamilton LLP (included in its Opinion filed as Exhibit 5.1 hereto). 24.1* Powers of Attorney (included on signature page). * Filed herewith. 5

Exhibit 4.5 SECOND AMENDMENT TO STOCKHOLDERS' AGREEMENT THIS SECOND AMENDMENT is dated as of June 29, 2001 (this "Second Amendment") to the Stockholders' Agreement dated as of March 30, 1999, as amended (the "Stockholders Agreement"), by and among OraSure Technologies, Inc. (as successor to STC Technologies, Inc.), a Delaware corporation (the "Company"), and the Investors identified therein. Capitalized terms not otherwise defined herein shall have the respective meanings set forth in the Stockholders' Agreement. WHEREAS, the Stockholders' Agreement provides the Investors with certain rights and the parties now desire to supplement and amend the terms of the Stockholders' Agreement pursuant to the terms of this Second Amendment. NOW, THEREFORE, in consideration of the premises and the mutual covenants contained herein and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, the Company and the Investors hereby agree as follows: 1. Limitations on Registration Rights; Holdback. (a) The Company may delay the filing, delay the effectiveness or suspend the effectiveness of a registration statement of the Company covering Restricted Shares as contemplated by Sections 3.4, 3.5 or 3.6 of the Stockholders' Agreement or otherwise prepared by the Company (including any shelf registration statement on Form S-3) (a "Registration Statement") or require the Investors to suspend sales or other dispositions of Restricted Shares under an effective Registration Statement, in each case for such time as may be required by the Company, if (i) in the Board's judgment, the sale of Restricted Shares thereunder would interfere with or be detrimental to a planned offering by the Company of any of the Company's securities, (ii) in the Board's judgment, the sale of Restricted Shares thereunder would have a material adverse effect on the business, prospects, operations, results of operations, assets, liabilities, or condition (financial or otherwise) of the Company; (iii) the Company is engaged in discussions concerning any possible merger, acquisition, financing, business combination, restructuring or sale of all or any substantial portion of the Company or its assets, or any similar transaction or (iv) the Company would be required to disclose in such Registration Statement material information that it would not otherwise be required to disclose in its filings with the Commission pursuant to the Exchange Act and that it has not then disclosed in such filings with the Commission (each an "Allowed Delay"). Notwithstanding the foregoing, the Company shall not be entitled to exercise its right to defer filing or effectiveness of or to suspend sales or other dispositions under a Registration Statement pursuant to an Allowed Delay for more than ninety (90) consecutive days. In the event of an Allowed Delay, the Company shall promptly (x) notify the Investors in writing (a "Delay Notice") of the existence (but not the substance) of the Allowed Delay and (y) advise the Investors in writing to cease all sales or other dispositions under such Registration Statement until the expiration of the period provided for in the Delay Notice. To the extent required by the Stockholders' Agreement, upon expiration of the Allowed Delay, the Company shall again be required to file, cause the effectiveness of, or permit the resumption of sales and dispositions under the Registration Statement. 1

(b) If the Company shall at any time register any of its securities under the Securities Act, for offer or sale to the public, then the Investors shall not make any short sale, assignment, transfer, pledge, hypothecation, gift or other disposition (including the grant of any option for sale) of any Restricted Shares (other than for the public sale of those Restricted Shares included in and sold pursuant to such registration) without the prior written consent of the Company for such period as may be designated by the Company and, if the registration shall be, in whole or in part, an underwritten offering, the managing underwriter; provided that no such period shall begin more than ten (10) days prior to the effectiveness of a Registration Statement pursuant to which such public offer or sale will be made and shall not last more than ninety (90) days after the effective date of such Registration Statement. (c) The Company shall use its commercially reasonable efforts to keep any Registration Statement covering Restricted Shares effective, including, but not limited to, preparing and filing with the Commission such amendments and supplements to such Registration Statement and the prospectus used in connection therewith as may be necessary to keep such Registration Statement effective until the earlier of (i) the sale of all Restricted Shares covered thereby or (ii) two years following the effective date of such Registration Statement. Notwithstanding the foregoing, the Company's obligations pursuant to this Section 1(c) and Section 3 of the Stockholders Agreement are subject to the terms of Section 1(a) hereof. 2. Obligations of the Investors. In connection with any registration of the Restricted Shares, each of the Investors shall: (a) furnish to the Company such information regarding itself, the Restricted Shares held by it and the intended method of disposition of the Restricted Shares held by it as shall be reasonably requested by the Company and shall execute such documents in connection with such registration as the Company may reasonably request; (b) cooperate with the Company as reasonably requested by the Company in connection with the preparation and filing of a Registration Statement or any amendment or supplement thereto; (c) upon receipt of any notice from the Company of the happening of any event of the kind described in Section 3.7(e) of the Stockholders Agreement, immediately discontinue disposition of Restricted Shares pursuant to a Registration Statement covering such Restricted Shares until the Investor's receipt of the copies of the supplemented or amended prospectus contemplated by such Section 3.7(e) and, if so directed by the Company, deliver to the Company (at the expense of the Company) or destroy (and deliver to the Company a certificate of destruction) all copies in the Investor's possession, of the prospectus covering such Restricted Shares current at the time of receipt of the notice of the happening of an event as described in such Section 3.7(e); (d) upon receipt of any Delay Notice, immediately discontinue the sale or disposition of Restricted Shares until the expiration of the Allowed Delay or any extension thereof pursuant to a subsequent Delay Notice; and 2

(e) comply with all applicable laws and regulations in connection with any sale, transfer or other disposition of Restricted Shares. 3. Indemnification. Each prospective seller, and any underwriter acting on its behalf, of Restricted Shares registered pursuant to any Registration Statement prepared by the Company, whether or not pursuant to Section 3 of the Stockholders' Agreement, will indemnify and hold harmless (in the same manner and to the same extent as set forth in Section 3.9(a) of the Stockholders' Agreement) the Company, each director of the Company, each officer of the Company who signs such Registration Statement and any person who controls the Company within the meaning of the Securities Act, with respect to any untrue statement or omission from such Registration Statement, any preliminary prospectus or final prospectus contained therein, or any amendment or supplement thereto, if such untrue statement or omission was made in reliance upon and in conformity with written information furnished to the Company through an instrument duly executed by such seller or such underwriter specifically for use in the preparation of such Registration Statement, preliminary prospectus, final prospectus or amendment or supplement; provided, however, that the maximum amount of liability in respect of such indemnification shall be limited, in the case of each prospective seller, to an amount equal to the net proceeds actually received by such prospective seller from the sale of Restricted Shares effected pursuant to such Registration Statement. 4. Acknowledgment of Obligations. Each prospective seller, and any underwriter acting on its behalf, of Restricted Shares registered pursuant to any Registration Statement prepared by the Company, whether or not pursuant to Section 3 of the Stockholders' Agreement, shall be bound by all of the applicable terms and provisions set forth in the Stockholders' Agreement and this Second Amendment. 5. Termination of Certain Provisions. Sections 2.1, 2.2, 2.4(a)(xiv), 2.4(b), 2.4(c), 2.7(e)(i), 2.9, and 2.12 of the Stockholders' Agreement are hereby terminated in their entirety and neither the Company nor any Investor shall have any further rights or obligations under such Sections. 6. Miscellaneous. (a) Successors and Assigns. Except as otherwise expressly provided in the Stockholders' Agreement or this Second Amendment, the provisions of the Stockholders' Agreement and this Second Amendment shall bind and inure to the benefit of the Company and each of the Investors and the respective successors and assigns of the Company and each of the Investors. Subject to the requirements of Section 3 of the Stockholders' Agreement, the Restricted Shares held by the Investors and all of the rights and obligations set forth in the Stockholders Agreement and this Second Amendment may be freely assigned, in whole or in part, by each Investor to any member of such Investor's Group; provided, however, upon the acceptance any Restricted Shares by any transferee of the Investor, such transferee shall automatically be bound by the obligations imposed under the Stockholders' Agreement and this Second Amendment to the same extent as if such transferee were an Investor. Upon any such transfer of Restricted Shares by an Investor, such Investor shall, as a condition to such transfer, deliver to the Company a written notice of such proposed transfer by which such the transferee is and the securities of the Company owned or acquired by such transferee are identified. A 3

transferee to whom rights are transferred pursuant to this Section 6(a) will be thereafter deemed to be an Investor for the purpose of the execution of such transferred rights and may not again transfer such rights to any other person or entity, other than as provided in this Section 6(a). Neither this Agreement nor any of the rights or duties of the Company set forth herein shall be assigned by the Company, in whole or in part, without having first received the written consent of the Investors holding a majority of the voting power of the outstanding Series A Preferred Shares held by all Investors, with each such holder entitled to the number of votes for each such share of Series A Preferred Stock as equals the number of shares of Common Stock (including fractional shares) into which each such share of Series A Preferred Stock is then convertible, rounded up to the nearest one-tenth of a share. (b) Except as otherwise provided herein, the provisions of the Stockholders' Agreement, including, but not limited to, Section 3 thereof, shall remain in full force and effect. To the extent that the terms of the Stockholders' Agreement conflict with the terms of this Second Amendment, the terms of this Second Amendment shall control. (c) The Stockholders' Agreement and this Second Amendment constitute the entire agreement among the parties hereto with respect to the subject matter hereof. There are no restrictions, promises, warranties or undertakings, other than those set forth or referred to herein and therein. (d) Failure of any party to exercise any right or remedy under this Second Amendment or otherwise, or delay by a party in exercising such right or remedy, shall not operate as a waiver thereof. (e) This Second Amendment shall be enforced, governed by and construed in accordance with the laws of the State of Delaware, without giving effect to conflict of laws principles. In the event that any provision of this Second Amendment is invalid or unenforceable under any applicable statute or rule of law, then such provision shall be deemed inoperative to the extent that it may conflict therewith and shall be deemed modified to conform with such statute or rule of law. (f) This Second Amendment may be executed in two or more counterparts, each of which shall be deemed an original but all of which shall constitute one and the same agreement. This Second Amendment, once executed by a party, may be delivered to the other party hereto by facsimile transmission of a copy of this Second Amendment bearing the signature of the party so delivering this Second Amendment. This Second Amendment shall be effective upon execution by the holders of not less than fifty percent (50%) of the outstanding Restricted Shares pursuant to Section 11 of the Stockholders' Agreement. (g) Each party shall do and perform, or cause to be done and performed, all such further acts and things, and shall execute and deliver all such other agreements, certificates, instruments and documents, as the other party may reasonably request in order to carry out the intent and accomplish the purposes of this Second Amendment and the consummation of the transactions contemplated hereby. [SIGNATURE PAGE FOLLOWS] 4

IN WITNESS WHEREOF, the Company and the Investors have caused this Second Amendment to be duly executed as of the date first above written. ORASURE TECHNOLOGIES, INC. By: /s/ Robert D. Thompson Name: Robert D. Thompson Title: Chief Executive Officer HEALTHCARE VENTURES V, L.P. By: HealthCare Partners V, its General Partner By: /s/ Jeffrey Steinberg Name: Jeffrey Steinberg Title: Administrative Partner HUDSON TRUST By:____________________________ Name:__________________________ Title:___________________________ PENNSYLVANIA EARLY STAGE PARTNERS, L.P. By: Pennsylvania Early Stage Partners GP, L.L.C., its General Partner By: /s/ Michael Bolton Name: Michael Bolton Title: Managing Director 5

Exhibit 5.1 July 3, 2001 OraSure Technologies, Inc. 150 Webster Street Bethlehem, Pennsylvania 18015 Re: Registration Statement on Form S-3 Ladies and Gentlemen: We have acted as counsel to OraSure Technologies, Inc., a Delaware corporation (the "Company"), in connection with the registration under the Securities Act of 1933, as amended (the "Act"), of an aggregate of 4,094,882 shares of the Company's common stock, $0.000001 par value (the "Shares"), held by HealthCare Venture Partners V, L.P. and Pennsylvania Early Stage Partners GP, LLC. This opinion is delivered in accordance with the requirements of Item 601(b)(5) of Regulation S-K under the Act. We have examined originals or copies, certified or otherwise identified to our satisfaction, of (i) the Registration Statement on Form S-3 covering the Shares (the "Registration Statement"); (ii) the Company's Certificate of Incorporation and Bylaws, as in effect on the date hereof; (iii) certain resolutions of the Board of Directors of the Company relating to, among other things, the issuance of the Shares; and (iv) such other documents relating to the Company and the proposed issuance of the Shares as we have deemed necessary or appropriate as a basis for the opinions set forth below. In our examination, we have assumed the legal capacity of all natural persons, the genuineness of all signatures, the authenticity of all documents submitted to us as certified or photostatic copies and the authenticity of the originals of such latter documents. As to any facts material to the opinions expressed herein which were not independently established or verified, we have relied upon statements and representations of officers and other representatives of the Company and others. Members of our firm are admitted to the Bar of the Commonwealth of Pennsylvania, and we express no opinion as to the laws of any other jurisdiction other than the 1

Federal laws of the United States of America and the General Corporation Law of the State of Delaware ("GCL"). Based upon and subject to the foregoing, we are of the opinion that the Shares have been duly and validly issued and are fully-paid and non-assessable by the Company under the GCL. We hereby consent to the filing of this opinion as an exhibit to the Registration Statement and to the reference to this firm under the caption "Legal Matters" in the prospectus filed as part of the Registration Statement. In giving this consent, we do not hereby admit that we are in the category of persons whose consent is required under Section 7 of the Act. This opinion is furnished by us, as your counsel, in connection with the filing of the Registration Statement and, except as provided in the immediately preceding paragraph, is not to be used, circulated, quoted or otherwise referred to for any other purpose without our express written permission or relied upon by any other person. Very truly yours, /s/ PEPPER HAMILTON LLP 2


                                                                    Exhibit 23.1

                    CONSENT OF INDEPENDENT PUBLIC ACCOUNTANTS

To OraSure Technologies, Inc.:

As independent  public  accountants,  we hereby consent to the  incorporation by
reference in this S-3  Registration  Statement of our report dated  February 23,
2001  included  in  OraSure  Technologies,  Inc.'s  Form 10-K for the year ended
December  31,  2000  and  to  all  references  to  our  Firm  included  in  this
Registration Statement.


                                    /s/ ARTHUR ANDERSEN LLP


Philadelphia, Pennsylvania
July 2, 2001

                                                                  Exhibit 23.2

                       Consent of Independent Accountants



We  hereby  consent  to the  incorporation  by  reference  on this  Registration
Statement  on Form S-3 of our report  dated  January  15,  2001  relating to the
financial  statements of Epitope,  Inc., which appears in OraSure  Technologies,
Inc.'s Annual Report on Form 10-K for the year ended  December 31, 2000. We also
consent to the reference to us under the heading  "Experts" in such Registration
Statement.




PricewaterhouseCoopers LLP

Portland, Oregon.
July 2, 2001