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January 26, 2010

Abbot Submits Early Detection HIV Test for FDA Approval

Abbott Laboratories has submitted a Premarket Approval application for its Architect HIV Ag/Ab Combo assay to the U.S. Food and Drug Administration for expedited review. The assay simultaneously tests for HIV antigens (proteins produced by the virus) as well as antibodies (proteins produced by the body).

It’s the first test of its kind and would allow for earlier detection of HIV.

“The potential to diagnose HIV in the acute phase of the disease [which can last up to 12 weeks after infection] when antibodies are not yet present would be an important development in the fight against HIV,” said Michael Warmuth, senior vice president of diagnostics at Abbott. “The earlier a patient can be diagnosed, the sooner the patient can be placed into care and the better chance there is to stop further spread of the virus.”

The Architect assay was approved for use in Europe in 2004.

Search: Abbott, Architect HIV Ag/Ab Combo, Centers for Disease Control and Prevention, antibody, antigen, FDA, Food and Drug Administration, CDC


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