Health Canada Clears Screening of Cadaveric Organ and Tissue Donors with the Avioq HTLV-I/II Microelisa System.
M2 PHARMA-January 28, 2016-Health Canada Clears Screening of Cadaveric Organ and Tissue Donors with the Avioq HTLV-I/II Microelisa System
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- US-based medical device company Avioq, Inc.'s Avioq HTLV-I/II Microelisa System assay has obtained Health Canada approval and can now be used for testing blood specimens from deceased (cadaveric, non-heart beating) organ and tissue donors, the company said on Thursday.
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.
HTLV-I is a human type C retrovirus which has been etiologically associated with Adult T-Cell Leukemia 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.
Avioq is a medical device company established to develop and market immunodiagnostic products.
The comapny also provides contract development and manufacturing services in its FDA licensed, ISO 13485 facilities.
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|Date:||Jan 28, 2016|
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