FDA Approves First Screening Tests for Tickborne Parasite
WEDNESDAY, March 7, 2018 -- The first set of blood screening tests for the tickborne parasite Babesia microti have been approved by the U.S. Food and Drug Administration.
B. microti infects 1,000 to 2,000 people per year in the United States, the agency said in a news release. In addition to being carried by blacklegged or deer ticks, the disease also can be transmitted via the blood, organs, or tissue of an infected donor.
"While babesiosis is both preventable and treatable, until today, there was no way to screen for infections amongst blood donors," Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research, said in a statement. "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."
The set of tests, known as the Imugen Babesia microti Arrayed Fluorescent Immunoassay, are not meant to diagnose the disease, the FDA warned. The tests are produced by the British pharmaceutical firm Oxford Immunotec. Results can only be produced at the company's facility in Norwood, Mass., the agency said.
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Posted: March 2018