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FDA Approves Avioq's Supplemental HIV Test

NEW YORK – Immunodiagnostic firm Avioq announced Friday its VioOne HIV Profile Supplemental Assay has received approval from the US Food and Drug Administration.

The enzyme-linked immunosorbent assay is used for confirmation and differentiation of individual antibodies directed to various gene products of HIV-1 and HIV-2 (group M and group O) in human serum or plasma, the Research Triangle Park, North Carolina-based company said in a statement. It is intended to be an additional and more specific test to confirm the presence of antibodies, while the CE-marked version of the test can also be used in epidemiological studies to differentiate recent and longstanding HIV-1 infections.

The test received CE marking in June 2019.