The U.S. Food and Drug Administration has approved a new test for blood donations, just the second test available to screen for two viruses linked to leukemia and neurologic disorders.
The blood test, developed by medical device company Avioq, detects antibodies to human T-lymphotropic virus type 1 (HTLV 1) and human T-lymphotropic virus type 2 (HTLV 2). In addition to screening blood donors for the presence of the viruses, the tests can help clinicians diagnose the viruses and other related diseases in patients. Avioq said the tests can also be used to screen organ donors.
Avioq, based in Research Triangle Park, North Carolina, is targeting a U.S. blood donation market that is estimated at 17 million donations a year. Both HTLV viruses can be transmitted by blood transfusion, reuse of syringes and breast feeding. Until now, the only FDA-approved test to screen for HTLV 1 and HTLV 2 is a product made by Abbott (NYSE:ABT).
Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement that the Avioq approval will allow for “greater flexibility to blood establishments and helping to assure the safety of the blood supply.”
HTLV 1 is a retrovirus that has been associated with adult T-cell leukemia and neurologic disorders tropical spastic paraparesis and HTLV 1-associated myelopathy. People who have these disorders have antibodies to HTLV 1. According to the FDA, HTLV 1 is regularly found in some Caribbean countries, southern Japan and possibly in some areas of Africa. In the United States, the virus has been found in leukemia patients, intravenous drug abusers as well as healthy individuals.
Avioq developed its HTLV tests under a 2010 partnership with Johnson & Johnson (NYSE:JNJ) subsidiary Ortho Clinical Diagnostics. Now that the test has been approved, Ortho Clinical will distribute the Avioq assay into the donor screening market. Avioq will handle sales to the clinical diagnostic market.