The CDC, Health Resources and Services Administration (HRSA) and its Prime Vendor Program worked collaboratively to design an alternative procurement model for Rapid HIV kits that would improve access to testing for more U.S. citizens and support the CDC's new HIV testing guidelines. Trinity Biotech is the first supplier of Rapid HIV test kits to be added to the program. The 340B Prime Vendor Program makes discounted drugs and other healthcare products available to participating covered entities through a contract awarded by the Health Resources and Services Administration's (HRSA) Office of Pharmacy Affairs, the federal agency responsible for managing the 340B Drug Pricing Program.
Providing results within 10 minutes, Uni-Gold is the only third generation rapid test for the detection of HIV antibodies approved by the U.S. Food and Drug Administration (FDA) for use with whole blood (finger stick or venipuncture), plasma and serum specimens. Uni-Gold is also CLIA waived for both whole blood applications. The Uni-Gold test uses a patented double antigen sandwich design that detects the presence of HIV antibodies in blood samples up to eight weeks earlier than other rapid tests available in the U.S.
"Trinity Biotech is proud to be part of the 340B Prime Vendor Program," said Brendan Farrell, President of Trinity Biotech. "We look forward to working with 340B program members to help provide Uni-Gold, the fastest and most sensitive rapid HIV test available, to those individuals most in need."
"We believe this agreement supports both President Bush's rapid HIV testing initiative outlined in his recent State of the Union Address and the CDC proposed guidelines aimed at making HIV testing part of routine healthcare for all Americans," added Farrell.
About Trinity Biotech
Trinity Biotech develops, acquires, manufactures and markets over 500 diagnostic products for the point-of-care and clinical laboratory segments of the diagnostic market. The broad line of test kits are used to detect infectious diseases, sexually transmitted diseases, blood coagulation disorders, and autoimmune diseases. Trinity Biotech sells worldwide in over 80 countries through its own sales force and a network of international distributors and strategic partners. For further information please see the Company's website: www.trinitybiotech.com.
Forward-Looking Statements
Forward-looking statements in this release are made pursuant to the "safe harbor" provision of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements involve risks and uncertainties including, but not limited to, the results of research and development efforts, the effect of regulation by the United States Food and Drug Administration and other agencies, the impact of competitive products, product development commercialisation and technological difficulties, and other risks detailed in the Company's periodic reports filed with the Securities and Exchange Commission.
Contact: Contact: Trinity Biotech plc Brendan Farrell (353)-1-2769800 e-MAIL: Email Contact
Source: Trinity Biotech plc
