Avioq announces CE Mark and European launch of HTLV-I/II test

May 2, 2013

Avioq, Inc., has received CE Marking for its Avioq HTLV-I/II test and has made it available in the European Union and other CE Mark countries. The CE Mark follows FDA approval and ISO 13485 certification in 2012. The product has been submitted for Health Canada approval and is being registered in countries worldwide.

“We are pleased to provide the FDA-approved Avioq HTLV-I/II assay to countries outside the U.S.,” says Chamroen Chetty, CEO of Avioq. “We will continue to partner with Ortho Clinical Diagnostics, which will be a non-exclusive distributor of the assay outside the U.S., adding HTLV-I/II to its extensive menu of assays.”

The Avioq HTLV-I/II assay features a user-friendly microplate design suitable for various testing volumes and automation. It is for the qualitative detection of antibodies to Human T Lymphotropic Virus Type I (HTLV-I) and Type II (HTLV-II) in serum or plasma. It is intended for screening individual human donors, and for use in clinical diagnosis of HTLV-I or HTLV-II infection and related diseases. It is also used in testing blood and plasma specimens to screen organ donors.

HTLV-I is a human type C retrovirus which has been etiologically associated with Adult T-Cell Leukemia (ATL) and with a demyelinating neurologic disorder termed Tropical Spastic Paraparesis, and/or HTLV-I Associated Myelopathy (TSP/HAM). Antibodies to HTLV-I are found with high frequency in persons affected with these disorders. In the United States, it has been identified in ATL patients, intravenous drug abusers, and healthy individuals. Visit Avioq for more information about the HTLV-I/II Microelisa System.