MP Biomedicals, Inc. Submits Biologic License Application (BLA) for FDA Approval of HTLV Confirmatory Test
1/28/2013 9:06:06 AM
SANTA ANA, Calif.--(BUSINESS WIRE)--MP Biomedicals, LLC announced today that it has submitted a BLA for FDA approval of the MP Diagnostics HTLV Blot 2.4, a Western blot for confirmatory testing and viral typing of blood donors and patients. Additionally, MP Biomedicals plans to initiate an open IND study in February, which will allow for investigational use (IUO) of the assay on donor and patient samples while the product is under FDA evaluation. The American Red Cross is among the study participants. U.S. labs interested in participating may contact Karen Luthart for more information (see above).