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The viruses, abbreviated HTLV-I/II, cause diseases such as adult T-cell leukemia/lymphoma (blood cancer) and myelopathy (inflammation of spinal cord nerves) , the FDA said in a news release. HTLV can be transmitted via breastfeeding, unprotected sex or blood transfusion.
The newly approved test -- MP Diagnostics HTLV Blot 2.4 -- is meant to supplement existing screening for the viruses, the FDA said. The diagnostic also can differentiate between the two types, HTLV-I or HTLV-II.
Many people infected with HTLV may not be aware of its presence, since the virus does not always trigger symptoms. An infected person can transmit the virus without showing any signs or symptoms, the agency said.
The new test is produced by a Singapore subsidiary of MP Biomedicals, based in Santa Ana, Calif.
-- Scott Roberts
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