FDA Approves Roche's First Whole Blood Donor Screening Test for Babesia Parasite

Today, Roche announced that the U.S. FDA has approved its first whole-blood screening assay for testing donated blood from volunteers, cobas Babesia, which detects Babesia parasites in blood, thereby reducing the risk of transfusion-transmitted parasitic infections. Babesia was undetectable using conventional blood sample testing methods in the past.

Babesia is a genus of pathogenic parasites that can act as pathogens and serve as vectors for disease transmission. In most cases, it is transmitted to humans through tick bites, but it can also be spread via blood transfusion or from mother to child. This parasite destroys red blood cells in the bloodstream, leading to anemia and other complications, particularly in elderly individuals and those with compromised immune systems. In healthy populations, infections may be asymptomatic or present with mild, flu-like symptoms. If left undetected, Babesia infection can be fatal for patients.

cobas Babesia Blood Screening Reagent is designed for use with the Roche cobas 6800/8800 fully automated molecular biology analyzers. This instrument enables screening laboratories to utilize advanced diagnostic technologies to test collected blood and plasma, thereby preventing the transmission of parasites through blood transfusions. Babesia cannot be detected in traditional plasma or serum samples. Roche’s new whole-blood collection tubes simplify sample preparation for Babesia testing, providing an effective solution for diagnostic laboratories. cobas Babesia is intended to detect the DNA and RNA of the four most common Babesia species that cause disease: B. microti, B. duncani, B. divergens, and B. venatorum.

▲ cobas Babesia (Image source: Roche official website)

According to Roche’s official materials, the fully automated cobas 6800/8800 systems are high-throughput, fully automated instruments that deliver rapid results and adapt to evolving testing needs. They provide enhanced operational efficiency and flexibility for blood and plasma screening laboratories. Since 2014, the cobas 6800/8800 systems have set a new standard for routine molecular testing in areas such as donor screening, infectious diseases, and antimicrobial stewardship, by offering fully integrated automation solutions.

▲cobas 6800/8800 Automated Molecular Platform (Image source: Roche official website)

“We are committed to helping patients by providing advanced solutions to protect the global blood supply from infectious diseases. Roche’s whole-blood testing for blood screening can help healthcare professionals further reduce the potential risk of transfusion-transmitted infections,” said Thomas Schinecker, CEO of Roche Diagnostics. “In addition, we aim to help customers improve laboratory efficiency by simplifying sample preparation, while maximizing the detection of infectious pathogens in blood to ensure the safety of the blood supply for the populations we serve.”

References:

[1] FDA approves Roche's first cobas test for whole blood donor screening，Retrieved September 20, 2019, from https://www.fiercebiotech.com/medtech/fda-approves-roche-s-first-cobas-test-for-whole-blood-donor-screening

[2] FDA approves cobas Babesia, Roche's first whole blood test for donor screening Swiss Stock Exchange:RO，September 20, 2019, from https://menafn.com/1099028194/FDA-approves-cobas-Babesia-Roches-first-whole-blood-test-for-donor-screening-Swiss-Stock-ExchangeRO

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