FDA News

FDA approves first-ever tests to screen for tickborne parasites

The FDA recently announced it has approved the Imugen Babesia microti Arrayed Fluorescent Immunoassay for detecting antibodies to Babesia 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.

“While babesiosis is both preventable and treatable, until today, there was no way to screen for infections amongst blood donors,” Peter Marks, MD, PhD, 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 assays would be used on samples from living organ and tissue donors as well as individual human donors, including volunteer donors of whole blood and blood components, the agency stated. The tests can only be conducted at Oxford Immunotec, Inc.’s Norwood, Massachusetts location.

The FDA stated it intends to release draft guidance with recommendations for reducing the risk for transfusion-transmitted babesiosis sometime in 2018. There is presently no FDA guidance for testing samples for Babesia.

There are approximately 1,000 to 2,000 annual cases of babesiosis reported annually in the U.S., making it the most common transfusion-transmitted parasitic infection, according to the FDA.

Disclosure: Marks works for the FDA.

 

The FDA recently announced it has approved the Imugen Babesia microti Arrayed Fluorescent Immunoassay for detecting antibodies to Babesia 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.

“While babesiosis is both preventable and treatable, until today, there was no way to screen for infections amongst blood donors,” Peter Marks, MD, PhD, 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 assays would be used on samples from living organ and tissue donors as well as individual human donors, including volunteer donors of whole blood and blood components, the agency stated. The tests can only be conducted at Oxford Immunotec, Inc.’s Norwood, Massachusetts location.

The FDA stated it intends to release draft guidance with recommendations for reducing the risk for transfusion-transmitted babesiosis sometime in 2018. There is presently no FDA guidance for testing samples for Babesia.

There are approximately 1,000 to 2,000 annual cases of babesiosis reported annually in the U.S., making it the most common transfusion-transmitted parasitic infection, according to the FDA.

Disclosure: Marks works for the FDA.