Breaking News From Pharma & Bio Ingredients Subscribe via RSS Subscribe via RSS



FDA OK's New HIV Test


Posted on 2006-06-21 14:35:00



Drug developer Bayer AG said Wednesday its healthcare diagnostics division received U.S. Food and Drug Administration approval for a new automated HIV test that can detect all known types of the infection.

The test, called the EHIV, or Human Immunodeficiency Virus-Enhanced, was approved for use on Bayer's ADVIA Centaur Immunoassay System. EHIV is an in vitro diagnostic test that looks for antibodies in human serum and plasma to HIV 1, HIV 2 and a subtype of HIV 1. The test is automated, allowing laboratories to increase testing with more accurate results, Bayer said in a statement.

The system is made and sold by Bayer Diagnostics for Ortho Clinical Diagnostics, a subsidiary of Johnson & Johnson.