The Food and Drug Administration (FDA) has approved Oxford Immunotec’s Imugen Babesia microti Arrayed Fluorescent Immunoassay for the detection of antibodies to Babesia microti (B. microti) in human plasma samples, and the Imugen Babesia microti Nucleic Acid Test for the detection of B. microti DNA in human whole blood samples. Babesiosis caused by the tickborne pathogen B. microti is the most frequently transfusion-transmitted parasitic infection in the U.S. Oxford Immunotec’s tests screen for this parasite in samples from individual human donors of whole blood and blood components, as well as living organ and tissue donors.
The investigational use of Babesia donor testing has been in place since August 2012 in selected Babesia endemic areas. The data collected from this testing and additional studies performed by Oxford Immunotec supported the approval of both Imugen tests through FDA’s 6-month priority review. The agency now plans to issue draft guidance later this year with recommendations for reducing the risk of transfusion-transmitted babesiosis.