To: Biomaven who wrote (8874 ) 7/29/2003 1:34:24 PM From: manny t Read Replies (2) | Respond to of 52153 OSUR, Is this news significant for the price of this stock? OraSure Receives Approval to Distribute OraQuick Rapid HIV-1 Antibody Test in Mexico; Approval Includes Oral Fluid Testing Business Wire - July 29, 2003 13:01 BETHLEHEM, Pa.--(BUSINESS WIRE)--July 29, 2003--OraSure Technologies, Inc. (Nasdaq NM:OSUR), the market leader in oral fluid diagnostics, announced today that it has received approval from the Ministry of Health in Mexico for its OraQuick (R)Rapid HIV-1 Antibody Test. Pursuant to this approval, the Company can distribute the OraQuick(R) test to healthcare professionals in Mexico for the detection of HIV-1 antibodies in both finger-stick whole blood and oral fluid samples. The approval was received in response to an application filed by the Company's exclusive OraQuick(R) distributor in Mexico, Pro-Consulting S.A. de C.V. In addition, the approval is based on a technical evaluation of the OraQuick(R) test performed by the National Diagnostic Institute and Epidemiological Reference "INDRE", which demonstrated 100% specificity and 100% sensitivity when used on oral fluid samples. Sensitivity is a measure of the accuracy for detecting HIV-1 positive specimens, and specificity is a measure of the accuracy for identifying negative specimens. "We are very pleased to have received the required regulatory approval to distribute OraQuick(R) into a market as important as Mexico," said Mike Gausling, OraSure's President and Chief Executive Officer. "This approval represents a significant step in an international strategy to extend our distribution network south of the United States into Mexico and ultimately into Central and South America and the Caribbean. Additionally, we are also thrilled, but not surprised, at the outstanding performance of the OraQuick(R) test, particularly in oral fluids, when tested by the Mexican Health Authorities." Mexico has a current population of approximately 100 million people. According to a 2002 report by UNAIDS, approximately 150,000 people were reported to be infected with HIV-1 at the end of 2001. The Company expects that its OraQuick(R) test will ultimately be sold to the National Social Medicine Services, National Council for HIV/AIDS, State HIV programs, non-governmental organizations, hospitals, clinics, physicians and other members of the professional healthcare community in Mexico. OraQuick(R) is the first FDA-approved rapid, point-of-care test designed to detect antibodies to HIV-1 in finger-stick whole blood within approximately 20 minutes. OraSure received FDA approval of the OraQuick(R) test on November 7, 2002. 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.