Santa Ana, CA-based MP Biomedicals has nabbed FDA approval for the first supplemental test designed to better identify blood donors that have tested positive for human T cell lymphotropic virus (HTLV).
The test, MP Diagnostics HTLV Blot 2.4, is meant to be used as an additional, more specific test on human serum or plasma samples that have already tested positive with an FDA-licensed blood donor screening test for HTLV-I and HTLV-II, two of the four known strains of HTLVs.
A qualitative enzyme immunoassay test, the HTLV Blot 2.4 confirms infection with the virus and is also able to differentiate between HTLV-I and HTLV-II strains, which have different health implications, according to MP Biomedicals.
"This marks the first FDA-approved infectious disease assay in the company's product portfolio, and we plan to continue building on this milestone," said MP Biomedicals CEO Milan Panic in a statement. "Our focus on quality remains our top priority."
A type of RNA virus, HTLV infects white blood cells called T lymphocytes. This family of viruses causes diseases like adult T cell leukemia, lymphoma and inflammation of the nerves in the spinal cord, as well as other conditions.
HTLV does not always cause symptoms or signs of infection, so many people with the virus may be unaware that they are infected. It's often not until these people decide to become blood donors that they discover their infection.
- get the FDA statement
- read the release from MP Biomedicals