FDA Approves Babesia Blood Test System

SEPTEMBER 20, 2019
Kevin Kunzmann
FDAThe US Food and Drug Administration (FDA) has approved a new whole blood test for donor screening.

Cobas Babesia, from Roche, has been approved for use on the cobas 6800/8800 Systems for individual blood donor testing. With the approval, the test becomes the first of its kind commercially available for its indication.

In May 2019, the FDA updated an industry guidance, recommending screening and testing for Babesia, as an effort to reduce parasite transmission risk through transfusions. The Roche-approved test detects parasites in red blood cells—an advancement due to the inability to detect Babesia parasite in traditional plasma or serum samples.

The test is able to detect 4 common species of Babesia in a whole blood collection tube, which Roche stated consolidates steps to providing efficient laboratory testing-prepared solution.

Babesia parasite is most commonly transmitted via infected tick bites to human, but may also come via blood transfusion or from mother to fetus in pregnancy. The parasite is capable of infecting and destroying red blood cells, putting patients at risk of anemia and life-threatening complications in elderly or immunocompromised patients. Among healthy patients, the infection can be anything from asymptomatic to flu-like in nature.

The FDA approval follows the previous Roche indication for its cobas Zika test—the first of its kind available for donor screening in the US. Thomas Schinecker, chief executive officer of Roche Diagnostics, said the whole blood test approval aligns with the company’s commitment to providing advanced solutions which enable protection from infectious diseases in global blood supplies.

“With the approval of Roche’s first whole blood test used in blood screening we can help healthcare professionals further diminish potential risks of infection from transfused blood products,” Schinecker said in a statement. “In addition, we hope to help customers improve their lab efficiency by simplifying sample prep while ensuring maximum detection of infectious pathogens in the blood and the safety of the blood supply for the patients we serve.”

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