OraSure Announces Resolution of Dispute with Abbott Laboratories
BETHLEHEM, Pa., Feb 23, 2004 (BUSINESS WIRE) -- OraSure Technologies, Inc. (Nasdaq NM:OSUR) announced the receipt of an arbitrator's decision resolving its dispute with Abbott Laboratories under the parties' distribution agreement for the Company's OraQuick(R) Rapid HIV-1 Antibody Test. The arbitrator ruled that the agreement was not terminated and will remain in effect. In addition, consistent with the arbitrator's rulings OraSure has notified Abbott that the agreement has been converted from co-exclusive to a non-exclusive distribution arrangement. Pursuant to the terms of the agreement, the arbitrator's determination is final and may not be appealed by either party.
"We are pleased that our dispute with Abbott has been resolved by the arbitrator and that our distribution agreement has been changed from co-exclusive to non-exclusive," said Mike Gausling, President and Chief Executive Officer of OraSure Technologies. "We can now proceed with our strategy to build a strong sales and distribution network for our OraQuick(R) test, which should allow us to maximize our penetration of the market for rapid HIV testing."
OraQuick(R) is the first rapid, point-of-care test approved by the FDA to detect antibodies to HIV-1 in fingerstick and venipuncture whole blood specimens within approximately 20 minutes. OraSure received FDA approval of the OraQuick(R) test for fingerstick whole blood on November 7, 2002 and for venipuncture whole blood on September 5, 2003. On January 31, 2003, OraSure received a CLIA (Clinical Laboratory Improvements Amendments of 1988) waiver for the test, permitting its use by more than 180,000 sites in the United States, including outreach clinics, community-based organizations and physicians' offices.
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices and tests and other diagnostic products using its proprietary technologies, including immunoassays and other in vitro diagnostic tests and other medical devices. These products are sold in the United States and certain foreign countries to clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, distributors, government agencies, physicians' offices, and commercial and industrial entities. For more information on the Company, please visit www.orasure.com.
Important Information
This press release contains certain forward-looking statements, including with respect to sales, markets, distributors and products. Actual results could be significantly different. Factors that could affect results include the ability to market products; impact of competitors, competing products and technology changes; ability to develop, commercialize and market new products; market acceptance of oral fluid testing products and up-converting phosphor technology products; ability to fund research and development and other projects and operations; ability to maintain new or existing product distribution channels (including our ability to implement a direct sales effort or other alternative distribution for OraQuick(R)); reliance on sole supply sources for critical product components; availability of related products produced by third parties; ability to obtain, and timing of obtaining, necessary regulatory approvals; ability to comply with applicable regulatory requirements; history of losses and ability to achieve sustained profitability; volatility of our stock price; uncertainty relating to patent protection and potential patent infringement claims; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally; loss or impairment of sources of capital; ability to meet financial covenants in agreements with financial institutions; ability to retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; changes in relationships with strategic partners and reliance on strategic partners for the performance of critical activities under collaborative arrangements; changes in accounting practices or interpretation of accounting requirements; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; the impact of terrorist attacks and civil unrest; ability to complete consolidation or restructuring activities; ability to identify, complete and realize the full benefits of potential acquisitions; and general political, business and economic conditions. These and other factors are discussed more fully in the Securities and Exchange Commission ("SEC") filings of OraSure Technologies, including its registration statements, its Annual Report on Form 10-K for the year ended December 31, 2002, its Quarterly Reports on Form 10-Q, and its other filings with the SEC. Although forward-looking statements help to provide complete information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. The forward-looking statements are made as of the date of this press release and OraSure Technologies undertakes no duty to update these statements.
SOURCE: OraSure Technologies, Inc.
OraSure Technologies, Inc. Ronald H. Spair, 610-882-1820 Investorinfo@orasure.com
