Pennsylvania: OraSure Begins Studies for its Home HIV Test
September 28, 2006
OraSure Technologies announced Wednesday it has launched studies of its rapid-result HIV test for in-home use by consumers. The company is conducting lab-based research and plans further clinical studies under an investigational device exemption filed with the Food and Drug Administration to use the device in safety and effectiveness studies to support regulatory approval. An FDA panel met in November to discuss home HIV testing. OraSure's rapid-result HIV test has been used in clinical settings since 2002. The test uses saliva or blood and delivers results in 20 minutes.
09.27.2006; Linda Loyd