The U.S. Food and Drug Administration Wednesday approved Oxford Immunotec’s screening tests for a malaria-like parasite infection called Babesiosis in blood donors.
Blacklegged or deer ticks, also known as Ixodes scapularis ticks, transmit Babesia parasites that cause the disease. In the U.S., there are around 1,000 to 2,000 cases of Babesiosis annually with most appearing in the Northeast and upper Midwest, according to the federal agency. Although some people display symptoms, most do not present any and remain undiagnosed.
The FDA approval now allows two of Oxford Immunotec’s screening tests to be used to screen blood samples of individual blood donors as well as of living organ and tissue donors.
The “Imugen Babesia microti Arrayed Fluorescent Immunoassay” helps detect antibodies to the Babesia microti species while the “Imugen Babesia microti Nucleic Acid Test” detects Babesia microti DNA in human whole blood samples.
The U.S. Centers for Disease Control and Preventions noted that Babesiosis is the most frequently reported transfusion-transmitted parasitic infection in the U.S. A person with an infection can transmit the disease through blood donation.
“While Babesiosis is both preventable and treatable, until today, there was no way to screen for infections amongst blood donors,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “Today’s actions represent the first approvals of Babesia detection tests for use in screening donors of whole blood and blood components and other living donors.”
Both are in-house tests only administered at the Norwood, Massachusetts facility, according to the FDA.