DUBLIN, Ireland — Trinity Biotech plc (NASDAQ:TRIBY) has received FDA marketing approval for its enzyme immunoassay (EIA) test for adenovirus. Developed in microtiter plate format, the test detects adenovirus antigens in stool samples.

Jim Walsh, chief operating officer for Dublin-based Trinity Biotech, said the U.S. clinical testing market for adenovirus is worth an estimated US$30 million.

Trinity Biotech's product has two significant competitors, he said. But the company aims to differentiate itself in the market by developing a complete panel of tests, allowing hospital laboratories to test for a range of microorganisms that cause gastrointestinal diseases.

It already has received FDA approval for its Rotavirus and Clostridium difficile tests, and it currently is working on kits for Giardia and Cryptospiridium.

Trinity Biotech's portfolio of FDA-approved diagnostic tests has increased dramatically during the past year, from just one product 12 months ago to more than 50 currently. (See BioWorld International, Jan. 22, 1997, p. 3.) Most of this total stemmed from Trinity's acquisition of Clark Laboratories last year, Walsh said. (See BioWorld International, Feb. 26, 1997, p. 1.) But a second acquisition, Centocor's U.K. infectious disease business, and Trinity Biotech's own product development activities also made a contribution.

The company has more than doubled in size as a result of the two acquisitions. Its current annualized revenues are on the order of US$20 million, Walsh said. And it expects to post profits of US$1.3 million for the current fiscal year.

The company will probably make another acquisition during the next 12 months, Walsh said. Even if it does not, though, organic growth and a full 12 months of revenues from the Centocor business will push sales well over the US$20 million mark, according to Walsh. The Centocor deal only became effective at the beginning of last July.

Trinity Biotech's product portfolio currently includes infectious diseases, serology, fertility, enteric diseases and autoimmunne diseases. It is now embarking on a program to develop a range of cancer diagnostics, which it licensed from Centocor Inc., of Malvern, Pa.

Walsh expects the first products to emerge from this program toward the end of this year. During the current quarter the company plans to launch an EIA assay for Chagas' disease, which is endemic in Latin America.

Additionally, clinical trials of its single-step rapid test for HIV are ongoing in the U.S., Uganda, India, Malaysia and Thailand, Walsh said, adding that the product already is achieving significant sales in the Far East.

No Comments