Procleix Babesia Assay gets FDA approval

Grifols has announced that following a successful clinical trial conducted under an Investigational New Drug study at the American Red Cross, Creative Testing Solutions, and Rhode Island Blood Center in select areas of the U.S, the FDA has approved the Procleix Babesia assay. The assay gives U.S. blood banks the ability to screen individual samples or up to 16 pooled lysed specimens from human donors, including donors of whole blood and blood components for transfusion whole blood donations, for the presence of the ribosomal RNA from four clinically relevant species of the Babesia parasite (B. microti, B. duncani, B. divergens, B. venatorum), a parasite that can be transmitted to humans by tick bites or through donated blood from Babesia-infected donors. It runs on a fully automated platform, the Procleix Panther system, which uses Nucleic Acid Testing for blood screening.
Carsten Schroeder, President of Grifols Diagnostic Commercial Division, said: “The FDA approval of the Procleix Babesia assay is the latest significant milestone for Grifols and reinforces our strong commitment to helping health professionals decrease potential risks of infection from donated blood. By monitoring new and re-emerging threats to blood supply, we continue in our mission to work with leading experts in the field and health authorities to improve patient safety by delivering innovative solutions on proven and reliable testing platforms.”