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HIV/AIDS Diagnostics

U.S. FDA approves test to help diagnose main virus that causes AIDS

Published in Medical Letter on the CDC and FDA, November 12th, 2006

The U.S. Food and Drug Administration (FDA) has approved the APTIMA HIV-1 RNA Qualitative Assay, manufactured by Gen-Probe Incorporated (San Diego, California).

The APTIMA assay, which detects the RNA-the nucleic acid or genetic material-of the HIV-1 virus, is the first test approved for the detection of HIV-1 RNA to help diagnose HIV-1 infection. HIV-1 is the main virus that causes AIDS.

"This product offers medical diagnostic laboratories the ability to perform a gene-based test for HIV-1 that, until now, was only available as part of a larger kit used to screen blood and plasma donors," said Jay Epstein, MD, director, Office of Blood Research and...

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