Epitope Inc. has received Food and Drug Administrationapproval to export its OraSure oral specimen device for use inHIV-1 testing, the company said Tuesday.
The Beaverton, Ore., company has received approval to exportOraSure to Australia, Belgium, Canada, Hong Kong, Ireland,Italy and Thailand. The company expects to receive approvalsfor other countries in the near future, according to Adolph J.Ferro, president and chief executive officer.
In July, the FDA forced Epitope (AMEX: EPT) to halt OraSuresales to the insurance industry in the United States, saying thetest did not have the required marketing approval. The companyfiled a premarket approval application with the FDA forprofessional use of OraSure in May 1991.
The stock closed Tuesday at $20.25, up $1.13. -- Steve Usdin
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