Avioq Expands FDA And CE-IVD Claims For Testing Organ And Tissue Donors With The Avioq HTLV-I/II Microelisa System

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Avioq, Inc. announced today that the Avioq® HTLV-I/II Microelisa System assay can now be used for testing blood specimens from deceased (cadaveric, non-heart beating) organ and tissue donors, expanding the range of approved uses in markets accepting FDA license and CE Mark. The new claims allow for pre-transplantation serum or plasma testing of living as well as deceased organ and tissue donors, thereby protecting transplant recipients from donation-related transmission of HTLV-I/II.

“Testing of donors prior to organ and tissue transplant with the HTLV-I/II Microelisa System allows healthcare professionals to provide an increased level of safety for transplant recipients”

“Testing of donors prior to organ and tissue transplant with the HTLV-I/II Microelisa System allows healthcare professionals to provide an increased level of safety for transplant recipients,” said Dr. Chamroen Chetty, CEO of Avioq. The expanded HTLV-I/II Microelisa System claim now allows rapid testing to meet the urgent nature of organ and tissue transplant procedures from deceased 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. HTLV-II has not been definitively linked to human illness but has been isolated from patients with a rare T-cell leukemia.

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. Avioq also provides contract development and manufacturing services in their FDA licensed, ISO 13485 facilities. For more information about the Avioq® HTLV-I/II Microelisa System, visit www.avioq.com.