Trinity Biotech has completed development of a seven-minutewhole blood hepatitis B test and expects to begin clinical trailssoon. It is the company's first step toward realizing its ultimategoal of a saliva-based hepatitis B test.
Michael Hubbard, a spokesman for the Dublin, Ireland,company, said Trinity (NASDAQ:HIVSY) expects to have thesaliva test available for clinical testing in a month or two. Thediagnostics company will file a 5(10)k with FDA, but Hubbardsaid the bulk of the market for both the blood-based andsaliva-based test will be outside the U.S.
Trinity markets an HIV 1/2 saliva-based test in severalcountries outside the U.S., including Mexico, Malaysia, Thailand,India and Kuwait. The company is also developing rapid saliva-based tests for infectious and sexually transmitted diseasesincluding rubella, herpes, cytomegalovirus and chlamydia.
Hubbard said the difference between Trinity's saliva-based testand Epitope Inc.'s saliva-collection device is that Trinity's testprovides an immediate analysis; the saliva sample is not sentout to a lab for analysis. -- Brenda Sandburg
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