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NEW YORK (360Dx) – The US Food and Drug Administration on Tuesday approved Oxford Immunotec's Imugen arrayed fluorescent immunoassay for the detection of antibodies to Babesia microti in human plasma samples, and the Imugen nucleic acid test for the detection of B. microti DNA in human whole blood samples.

The FDA noted that the approved assays are in-house tests that can only be performed at Oxford Immunotec's facility in Norwood, Massachusetts, and that the tests are not intended for use in the diagnosis of babesiosis infections.

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