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news.Bayer HealthCare Diagnostics, a member of the Bayer Group, has won FDA approval for its fully-automated antibody test for HIV.
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The healthcare company said the FDA cleared the test, called EHIV (HIV Enhanced), which it hopes to sell under a business arrangement with US-based healthcare company Johnson & Johnson.
“With the addition of the EHIV test, Bayer offers the most comprehensive fully automated infectious disease portfolio in the US, thus enabling laboratorians to enhance their level of testing and aid physicians in making treatment decisions,” said Tony Bihl, president of Bayer Diagnostics.
Bayer's ADVIA Centaur EHIV test is an in vitro diagnostic immunoassay for the qualitative determination of antibodies to HIV 1, HIV 2 and HIV 1 – sub-type O in human serum and plasma.
The EHIV test is developed, manufactured and sold by Bayer Diagnostics for Ortho Clinical (Ortho) Diagnostics, a subsidiary of Johnson & Johnson, under an agreement entered into with Bayer, Ortho and Chiron Corporation in 2001. Under the terms of the agreement, Bayer will not represent the product for blood or plasma screening.