Oct. 6, 2017—Roche announced immediate plans to initiate screening of blood samples with the Cobas Babesia test under an FDA investigational new drug application protocol. The Cobas Babesia test is a qualitative in vitro nucleic acid screening test for the direct detection of babesia DNA and RNA in whole blood specimens from individual human blood donors. It has been specifically designed for use with the Cobas 6800/8800 mid- and high-volume molecular diagnostics systems, enabling the detection of four common strains of babesia in samples of donated blood. The Cobas Babesia test can be run alongside the Cobas Zika test from Roche.
The babesia parasite is commonly transmitted to humans through the bite of an infected tick, although it can also be transmitted through blood transfusions or from mother to fetus during pregnancy. The parasite infects and destroys red blood cells. In healthy individuals babesiosis can be asymptomatic or cause a range of mild flu-like symptoms. More than 200 cases of transfusion-transmitted babesia infections have been documented in the United States since 1979.
Roche is currently working with designated study sites in the U.S. to commence testing under the study protocol.