FDA APPROVES TEST TO DETECT GENETIC MATERIAL OF HIV-1 VIRUS

The FDA Oct. 5 said it has approved the APTIMA HIV-1 RNA qualitative assay to help diagnose HIV infection. The product will be under the purview of the Center for Biologics Evaluation and Research (CBER).

The test, manufactured by Gen-Probe, is the first one approved to detect the RNA -- the nucleic acid or genetic material -- of the HIV-1 virus, the agency said.

Medical diagnostic laboratories can now perform a gene-based test for HIV-1; previously this had only been available as part of a larger kit used to screen blood and plasma donors, said Jay Epstein, director of CBER's Office of Blood Research and Review.

"This test also can detect infection with HIV-1 earlier than HIV antibody tests when used to detect primary HIV-1 infection," he said.