FDA OKs cobas Babesia, Roche’s First Whole Blood Test for Donor Screening

Roche 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.¹
 
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.
 
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 foetus during pregnancy. The parasite infects and destroys red blood cells which can lead to anaemia 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.
 
“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.”
 
The Roche Blood Safety Solutions offering now provides the most comprehensive testing solution for blood donor screening utilising the fully automated cobas 6800/8800 System. This novel test approval follows the successful launch of the cobas Zika test, which was the first Zika test available for donor screening in the U.S. This new Babesia test expands the menu of tests available for the cobas 6800/8800 Systems for use in U.S. donor screening laboratories. This menu includes cobas MPX, cobas WNV and cobas Zika. In addition, the menu includes cobas DPX², which is used in testing labs that support plasma fractionators.
 
The cobas Babesia test for use on the cobas 6800/8800 Systems 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 detects the four species of Babesia known to cause disease in humans and can be performed with the other routine blood donor screening tests.
 
The fully automated cobas 6800/8800 Systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms, providing donor screening laboratories with improved operating efficiency and the flexibility to adapt to changing testing demands. The cobas Babesia test is the latest addition to Roche’s assay menu for donor screening laboratories—which includes cobas MPX, cobas DPX, cobas HEV, cobas WNV, cobas CHIKV/DENV and cobas Zika (US-IVD)—all of which are run on the cobas 6800/8800 Systems. Not all assays are available in all markets.
 
Since 2014, the cobas 6800 and cobas 8800 Systems have established the new standard for routine molecular testing by delivering fully integrated, automated solutions that serve the areas of donor screening, infectious disease, sexual health, transplant, respiratory and antimicrobial stewardship.
 
References
¹ “Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis”, FDA, May 2019
² This test has been submitted to the FDA as a Master File and will not have a regulatory classification, and will not be cleared, licensed or approved by the FDA.