U.S. Navy Purchases OraQuick HIV-1 Test; Part of Smallpox Vaccination Program
OraQuick(R) is a finger-stick whole blood test and the first FDA-approved, CLIA-waived, rapid point-of-care test designed to detect antibodies to HIV-1 within approximately 20 minutes.
The OraQuick(R) test, which received FDA approval in November 2002 and a CLIA waiver on January 31, 2003, has a sensitivity of 99.6% and specificity of 100% based on clinical studies performed by OraSure in support of the FDA approval. Sensitivity is a measure of the accuracy for detecting positive specimens, and specificity is a measure of the accuracy for identifying negative specimens.
According to the Centers for Disease Control and Prevention, the smallpox vaccine to be used by the Navy may cause complications for individuals with compromised immune systems and therefore should not be administered to people who are infected with HIV-1. The OraQuick(R) test will be used to screen individuals for HIV-1 infection, thereby helping to reduce the risks associated with receiving the vaccine.
The mariners of the Military Sealift Command are civilians who have been directed to receive smallpox immunizations pursuant to U.S. Department of Defense guidance. The OraQuick(R) Test is expected to be used at several Military Sealift Command locations worldwide.
"We are very proud to support our military by making the OraQuick(R) Test immediately available," said Mike Gausling, Chief Executive Officer of OraSure Technologies. "Using the OraQuick(R) Test to screen for HIV-1 in advance of administering the smallpox vaccine is an ideal use for our rapid HIV-1 test. We are honored to make this test available to both military and healthcare personnel for this particular purpose."
About OraSure Technologies
OraSure Technologies develops, manufactures and markets oral fluid specimen collection devices using proprietary oral fluid technologies and diagnostic products, 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 government agencies, clinical laboratories, physicians' offices, hospitals, commercial and industrial entities, and various distributors.
OraSure Technologies is the leading supplier of oral-fluid collection devices and assays to the life insurance industry and public health markets for the detection of antibodies to HIV-1. In addition, the Company supplies oral-fluid testing solutions for drugs of abuse testing. For more information on the Company, please go to www.orasure.com.
Important Information
This press release contains certain forward-looking statements, including with respect to sales, markets 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 or other products; ability to fund research and development and other projects and operations; ability to obtain and timing of obtaining necessary regulatory approvals; ability to develop product distribution channels; uncertainty relating to patent protection and potential patent infringement claims; 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; 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 inventory practices and consolidations; equipment failures and ability to obtain needed raw materials and components; the impact of terrorism and civil unrest; and general business, political and economic conditions.
These and other factors are discussed more fully in the Securities and Exchange Commission filings of OraSure Technologies, including its registration statements, its Annual Report on Form 10-K for the year ended December 31, 2001, and its most recent Quarterly Report on Form 10-Q.
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.
CONTACT: OraSure Technologies, Inc.
Investor Contact:
Ronald H. Spair, 610/882-1820
Investorinfo@orasure.com
www.orasure.com
or
Media Contact:
William Bruckner, 610/882-1820
wbruckner@orasure.com
Copyright (C) 2003 Business Wire. All rights reserved.
