Avioq Announces CE Mark and European Launch of HTLV-I/II Test
Published: Apr 11, 2013
CE Mark follows FDA approval in March 2012, and ISO 13485 certification in September 2012. The product has been submitted for Health Canada approval and is being registered in multiple countries world-wide. “We are pleased to provide the FDA approved Avioq HTLV-I/II assay to countries outside the U.S.” said Chamroen Chetty, CEO of Avioq. Dr. Chetty continues, “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 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, 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. It is also used in testing blood and plasma specimens to screen organ donors.
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-I is endemic in some Caribbean countries, southern Japan, and possibly in some areas of Africa. In the United States, HTLV-I has been identified in ATL patients, intravenous drug abusers, and in healthy individuals.
Avioq, Inc., located in Research Triangle Park, North Carolina, is a medical device company established to develop and market high-quality immunodiagnostic products. Avioq is committed to working closely with its customers to meet their needs and provide the highest quality service. For more information about the Avioq® HTLV-I/II Microelisa System, visit www.avioq.com.
Mike Cronin, 919-314-5535