Roche announced Friday that it has received approval from the U.S. Food and Drug Administration (FDA) for the cobas Babesia test for use on the cobas 6800/8800 Systems for individual blood donation testing.
This is Roche’s first commercially available whole blood test to screen donations and follows May 2019 FDA-updated industry guidance recommending screening and testing for Babesia, to reduce the risk of transmitting the parasite through transfusions.
cobas Babesia detects parasites that live in red blood cells. This test is an important advancement because the Babesia parasite cannot be detected in traditional plasma or serum samples. The test is able to detect the four common species of Babesia and employs the new whole blood collection tube, which simplifies Babesia sample preparation by consolidating steps within the tube itself to provide an efficient solution for testing laboratories.
“We are dedicated to helping save patients’ lives by providing advanced solutions to enable the protection of the global blood supply from infectious diseases. 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,” said Thomas Schinecker, CEO Roche Diagnostics. “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.”
In most cases, the Babesia parasite is transmitted to humans through the bite of an infected tick; however, the parasite 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, particularly in the elderly or otherwise immunocompromised patients. In healthy people, the infection can be asymptomatic, or cause a range of mild flu-like symptoms.