Avioq receives premarket approval from FDA for Avioq HIV-1 Microelisa System

Dec 1 2009

Avioq, Inc. announced it has received premarket approval from the U.S. Food and Drug Administration (FDA) for the Avioq HIV-1 Microelisa System. The test is used for the qualitative detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human specimens collected as serum, plasma, dried blood spots, or oral fluid specimens obtained with the OraSure^® HIV-1 Oral Specimen Collection Device. It is the only HIV-1 Microelisa System to have FDA approval for the qualitative detection of antibodies in oral fluid specimens. The Avioq HIV-1 Microelisa System is intended for use as an aid in diagnosis of infection with HIV-1.

The Avioq HIV-1 assay features a user-friendly microplate design with color-coded, liquid, ready-to-use reagents. The assay volume and incubation time are suitable for automation. This assay demonstrated excellent sensitivity and specificity in clinical studies used for approval. The Avioq assay is an improved version of the Vironostika™ HIV-1 Microelisa System, which was licensed from bioMérieux, Inc. It is the only assay utilizing HIV-1 whole viral lysate for a solid phase. Use of viral lysate enables broad detection across various clades of HIV-1, including excellent cross-reactivity to HIV-2.

The CDC now recommends routine, voluntary HIV testing in all health care settings, including health clinics and emergency rooms, for all individuals ages 13 to 64 without written informed consent. In addition, testing is recommended at least once a year for those at high risk.

By latest estimates, approximately 1,039,000 to 1,185,000 people in the United States are living with HIV/AIDS, with 24 to 27 percent undiagnosed and unaware of their HIV infection.

The Avioq HIV-1 Microelisa System can help meet new demands for increased testing created by new U.S. Centers for Disease Control and Prevention (CDC) testing recommendations.