FDA approves tests of tick-borne disease to protect blood supply

Testing under an IND led to a “significant number” of infected units being pulled from the blood supply. (FDA)

The FDA has approved tests to screen whole blood and plasma for a tick-borne disease. Approval of the Oxford Immunotec tests give the U.S. healthcare system a way to stop the spread of babesiosis, a life-threatening disease carried by deer ticks.

Babesiosis results from infection by Babesia microti, a parasite that is transmitted by small arachnids commonly known as blacklegged or deer ticks. Around 1,000 to 2,000 cases are reported each year in the U.S. but, as most infectees are asymptomatic, many more infections go undiagnosed. This poses a threat to the healthcare system, as the disease can be transmitted via blood or blood components. 

Now, the FDA and Oxford Immunotec have given blood banks tools to mitigate the threat. The FDA approvals cover two babesiosis-related tests. One is an arrayed fluorescent immunoassay designed to spot antibodies against the parasite in human plasma. The other is a nucleic acid test for B. microti DNA in human whole blood.

The clearances allow Oxford Immunotec to perform the tests at the Norwood, Massachusetts, facility it gained in its $22 million takeover of Imugen. The takeover also gave Oxford Immunotec ownership of the tests for B. microti infection and other tick-borne diseases. 

Oxford Immunotec won approval of the tests under the FDA’s priority review pathway. Prior to getting the green light, Oxford Immunotec provided donor testing for the disease in parts of the U.S. where it is endemic under an IND. That led to a “significant number” of infected units being pulled from the blood supply. The FDA approvals clear the tests for broader use.

“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.”