FDA approves Avioq HTLV screening system

Avioq, Inc. announced it has received approval from the U.S. Food and Drug Administration (FDA) for the Avioq® HTLV-I/II Microelisa System. The test is used for the qualitative detection of antibodies to Human T-Lymphotropic Virus Type I (HTLV-I) and Human T-Lymphotropic Virus Type II (HTLV-II) in human serum or plasma. It is intended for screening individual human donors, including volunteer donors of whole blood and blood components and other living donors for the presence of anti-HTLV- I/ HTLV-II, and for use as an aid in clinical diagnosis of HTLV-I or HTLV-II infection and related diseases. It is also intended for use in testing blood and plasma specimens to screen organ donors.

There are approximately 16 million blood donations a year1. “For many years, the donor screening community has been limited to one option for HTLV testing. We are pleased to be able to address this need by providing the Avioq HTLV-I/II assay as an alternative test,” said Chamroen Chetty, CEO of Avioq, Inc. Dr. Chetty continues, “As we announced last year, Ortho Clinical Diagnostics will distribute the Avioq assay into the donor screening market, adding HTLV-I/II to their extensive menu of assays. We are pleased to have a partner who is as committed as we are to the donor screening community.” The introduction of the Avioq® HTLV-I/II Microelisa System fulfills Avioq’s commitment to expand its Retrovirus product portfolio.

The Avioq® HTLV-I/II assay features a user-friendly microplate design suitable for various testing volumes and automation. In addition to being used as a manual assay, the assay is also intended for use with the ORTHO® Summit System (OSS) in the screening of blood donors. Ortho Clinical Diagnostics is the exclusive distributor of the Avioq® HTLV-I/II Microelisa System in the U.S. donor screening market. Avioq will sell direct to the Clinical Diagnostic market.