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.
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.