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Abbott submits PMA for HIV test

This article was originally published in The Gray Sheet

Executive Summary

Abbott has submitted a pre-market approval application to FDA for its Architect HIV Ag/Ab Combo assay, intended to aid in the early detection of HIV infection, the firm announces Jan. 25. The combined antibody and antigen test offers the potential to diagnose HIV in the acute phase of the disease and "would be an important development in the fight against HIV," said Michael Warmuth, Abbott senior VP-diagnostics. Current antibody-only tests fail to identify up to 10% of HIV infection in some populations, according to Abbott. The firm has requested expedited review from FDA
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