NEW YORK (GenomeWeb) – Roche said today that it plans to immediately initiate screening of blood samples with its Cobas Babesia test under an investigational new drug application protocol, and it is working with designated study sites in the US to commence testing.
The qualitative in vitro nucleic acid screening test performs direct detection of Babesia DNA and RNA in whole blood specimens from human blood donors.
It enables the detection of four common strains of Babesia in samples of donated blood. Where needed, the test can be run alongside the firm's Cobas Zika test, which was introduced under a separate investigational new drug application protocol in 2016, Roche said.
Roche noted that the Cobas Babesia test is its newest to have been specifically designed for use on the Cobas 6800/8800 mid- and high-volume molecular diagnostics systems.
Uwe Oberlaender, head of Roche Molecular Diagnostics, said in a statement that the Roche Babesia test adds to its rapidly expanding menu on the Cobas 6800/8800 systems, "which in turn helps healthcare professionals diminish potential risks of infection from transfused blood products."
Babesia parasite transmission is reported to be the most common cause of transfusion-related infectious fatalities in the US, Roche said. The Babesia parasite is commonly transmitted to humans through the bite of an infected tick. But it can also be transmitted through blood transfusions, or from mother to fetus during pregnancy.
The parasite infects and destroys red blood cells, which can lead to anemia and related life-threatening complications in the elderly, immunocompromised, and individuals without a spleen. In healthy individuals, the infection called babesiosis can be asymptomatic or can cause a range of mild flu-like symptoms.
Although the Babesia test has not been cleared or approved by the US Food and Drug Administration, US blood-screening laboratories can use it under an IND. However, testing laboratories must be enrolled in a clinical trial as specified and agreed upon with the FDA Center for Biologics Evaluation and Research.