FDA Approves Qualitative Nucleic Acid Test Intended for HIV Detection

FDA on Thursday approved San Diego-based Gen-Probe's qualitative nucleic acid test intended to detect HIV, Reuters UK reports (Reuters UK, 10/5). The test, called Aptima HIV 1 RNA Qualitative Assay, is a diagnostic test that detects the nucleic acid or genetic material of HIV 1 before the antibodies associated with the virus appear, according to an FDA release. "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," Jay Epstein, director of FDA's Office of Blood Research and Review, said, adding, "This test also can detect infection with HIV 1 earlier than HIV antibody tests when used to detect primary HIV 1 infection" (FDA release, 10/5). The approval of Aptima comes one day after FDA approved Gen-Probe's Procleix Ultrio test -- which screens donated organs, tissue, blood and plasma for HIV 1 and hepatitis C and B -- the AP/Houston Chronicle reports. Gen-Probe announced that it will launch Aptima in November in conjunction with the Procleix Ultrio test (AP/Houston Chronicle, 10/5).

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