RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Avioq, Inc. announced it received Health Canada approval in July 2013 and has begun marketing the Avioq® HTLV-I/II test in Canada.
Health Canada approval follows FDA licensure in March 2012, ISO 13485 certification in September 2012, and CE Mark in November 2012. The product is being registered in multiple countries world-wide. “We are pleased to provide the Avioq HTLV-I/II assay to Canada, which completes our initial goal for achieving four critical milestones: FDA, ISO, CE Mark and Health Canada approvals,” said Dr. Chamroen Chetty, Ph.D., CEO of Avioq. Dr. Chetty also states, “We will continue to partner with Ortho Clinical Diagnostics, who will be a non-exclusive distributor of the assay outside the U.S., adding HTLV-I/II to their extensive menu of assays. We are also looking for more distribution partners to expand the global availability of this product.”
The Avioq HTLV-I/II assay features a user-friendly microplate design that can be used with automation for the qualitative detection of antibodies to Human T-Lymphotropic Virus Type I (HTLV-I) and Type II (HTLV-II) in serum or plasma. The assay is intended for screening individual human donors, including volunteer donors of whole blood and blood components, and for use in clinical diagnosis of HTLV-I or HTLV-II infection and related diseases. Serum and plasma specimens from organ donors may also be screened.
About Human T-Lymphotropic Virus
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. HTLV-II, a related virus, is endemic in several Amerindian tribes, but has not been unequivocally proven to be a pathogen. A high rate of HTLV-II seropositives has been observed among intravenous drug abusers. The first reported patients with HTLV-II infections presented with an atypical T-cell variant of hairy cell leukemia. Antibodies to HTLV-II are significantly cross-reactive to HTLV-I antigens.
About Avioq
Avioq, Inc., located in Research Triangle Park, North Carolina, is a medical device company established to develop and market high-quality immunodiagnostic products. For more information about the Avioq® HTLV-I/II Microelisa System, visit www.avioq.com.
