First Screening Tests Approved 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.
Also dubbed B. microti, the parasite 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 [the disease] babesiosis is both preventable and treatable, until today, there was no way to screen for infections amongst blood donors," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
Most people infected with the parasite don't develop symptoms and are never diagnosed, the FDA said. Some people develop flu-like symptoms, such as fever, headache and body aches.
For some people with weakened immune systems, however, the infection may become life-threatening, the agency added.
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 pharma firm Oxford Immunotech. Results can only be produced at the company's facility in Norwood, Mass., the agency said.
Visit the FDA to learn more.
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Posted: March 2018