To All,
Trinity Biotech Announces Collaboration with Calypte
DUBLIN, Ireland -- Trinity Biotech (Nasdaq: TRIBY) today announced that it has signed an agreement with Calypte Biomedical (Nasdaq: CALY) to develop the world's first one-step urine based HIV test.
The first phase of the project will investigate the feasibility of developing a urine-based one-step HIV test utilizing Trinity's UniGold format. If the feasibility phase proves successful and results indicate that an assay can be developed with desired specifications, then the companies will jointly develop the product. The companies will share marketing rights to the product worldwide. The product would be manufactured by Trinity Biotech.
The collaboration combines Calypte's expertise in urine assay development for HIV with Trinity's expertise in developing one-step rapid tests for HIV. Calypte is the only company with an FDA licensed laboratory based urine HIV test. Trinity is the only company to have submitted a rapid one-step whole blood HIV test to the FDA for approval. The companies believe that the initial market for the test would be doctors' offices, clinical laboratories or remote testing sites. A second potential market for the product would be for the over-the-counter market. Both companies believe that the market for rapid, easy to use home tests will develop rapidly over the coming years. Home testing is a rapidly growing market and several "first generation" home collection blood based services for HIV have recently received FDA approval. In addition, improved HIV therapy is showing that early diagnosis is very important in reducing viral load and spread of infection at an early stage.
Ronan O'Caoimh, CEO of Trinity, commenting on the agreement, stated, "We are very excited about the prospects for a rapid urine HIV test. By combining each company's unique talents, we expect to create a test which is not only accurate, but simple and fast enough to address a wide variety of HIV testing needs worldwide."
Jack Davis, President and CEO of Calypte stated, "Tremendous progress has been made in our understanding of HIV, the virus that causes AIDS, and some very promising therapies are emerging. Now more than ever, we must make testing and diagnosis more palatable to those who have declined it in the past and more accessible to those who have been denied it in the past.
This rapid urine test would make reliable HIV testing as feasible to perform in the most arduous field conditions as it would be in a doctor's office. The test may ultimately be available over-the-counter, as HIV therapies and the prospects for a cure continue to improve."
Calypte Biomedical Corporation, with offices in Berkeley and Alameda, California, is the exclusive licensee of several patents related to urine HIV testing. In August 1996, Calypte received the first FDA license for a urine HIV-1 antibody test. That test is designed for use in high-volume, professional laboratories, and laboratory equipment is required to perform it.
Trinity Biotech develops, manufactures and markets rapid tests for the clinical laboratory, point-of-care and over-the-counter markets.
/CONTACT: Jonathan O'Connell of Trinity Biotech, 800-603-8076; or Robert
Long of LongView Partners, 212-463-9733/
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