Avioq Receives FDA Approval for HTLV-I/II Microelisa System

RESEARCH TRIANGLE PARK, N.C.--()--Avioq, Inc. announced it has received approval from the U.S. Food and Drug Administration (FDA) for the Avioq® HTLV-I/II Microelisa System. The test is used for the qualitative detection of antibodies to Human T-Lymphotropic Virus Type I (HTLV-I) and Human T-Lymphotropic Virus Type II (HTLV-II) in human serum or plasma. It is intended for screening individual human donors, including volunteer donors of whole blood and blood components and other living donors for the presence of anti-HTLV- I/ HTLV-II, and for use as an aid in clinical diagnosis of HTLV-I or HTLV-II infection and related diseases. It is also intended for use in testing blood and plasma specimens to screen organ donors.

There are approximately 16 million blood donations a year1. “For many years, the donor screening community has been limited to one option for HTLV testing. We are pleased to be able to address this need by providing the Avioq HTLV-I/II assay as an alternative test,” said Chamroen Chetty, CEO of Avioq, Inc. Dr. Chetty continues, “As we announced last year, Ortho Clinical Diagnostics will distribute the Avioq assay into the donor screening market, adding HTLV-I/II to their extensive menu of assays. We are pleased to have a partner who is as committed as we are to the donor screening community.” The introduction of the Avioq® HTLV-I/II Microelisa System fulfills Avioq’s commitment to expand its Retrovirus product portfolio.

The Avioq® HTLV-I/II assay features a user-friendly microplate design suitable for various testing volumes and automation. In addition to being used as a manual assay, the assay is also intended for use with the ORTHO® Summit System (OSS) in the screening of blood donors. Ortho Clinical Diagnostics is the exclusive distributor of the Avioq® HTLV-I/II Microelisa System in the U.S. donor screening market. Avioq will sell direct to the Clinical Diagnostic market.

About Human T-Lymphotropic Virus

HTLV-I is a human type C retrovirus2 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 is related to HTLV-I and 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 abusers3. Antibodies to HTLV-II are significantly cross-reactive to HTLV-I antigens.

Transmission of HTLV-I and HTLV-II infections to transfusion recipients of infected cellular blood products is well documented. Other known modes of transmission include breast milk, sexual contact, and sharing of contaminated needles and syringes by intravenous drug abusers. Perinatal transmission is suspected but remains unproven.

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 is committed to working closely with its customers to meet their needs and to provide the highest quality service. For more information about the Avioq® HTLV-I/II Microelisa System, visit the web site at www.avioq.com.

1 http://www.redcrossblood.org/learn-about-blood/blood-facts-and-statistics#blood-supply. Accessed July 5, 2011

2 Poiesz BJ, et al. Detection and Isolation of type C Retrovirus Particles from Fresh and Cultured Lymphocytes of a Patient with Cutaneous T-Cell Lymphoma. Proc Natl Acad Sci USA 1980; 77 (12): 7415-7419.

3Lee H, et al. High rate of HTLV-II infection in seropositive drug abusers in New Orleans. Science, 1989; 244: 471-5.

Contacts

Avioq
Mike Cronin, 919-314-5535

Release Summary

HTLV-I/II

Contacts

Avioq
Mike Cronin, 919-314-5535