Grifols, Barcelona, Spain, a global producer of plasma-derived medicines, has announced FDA approval of the Procleix Babesia assay, a qualitative assay for the detection of ribosomal RNA from four Babesia species (B. divergens, B. duncani, B. microti, B. venatorum) in individual samples or up to 16 pooled lysed specimens from human donors, including whole blood and blood components for transfusion.

The assay runs on the Procleix Panther system—a fully automated platform utilizing nucleic acid testing for blood screening. The agency’s approval recognizes a successful multicenter clinical trial conducted under an investigational new drug application by researchers at the American Red Cross, Creative Testing Solutions, and Rhode Island Blood Center (an affiliate of the New York Blood Center Inc), in select areas of the United States.

Schroeder

Carsten Schroeder, Grifols.

“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,” says Carsten Schroeder, president of the commercial diagnostics division at Grifols. “By monitoring new and reemerging threats to the 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.”

Babesia is a parasite that can be transmitted to humans by tick bites or through donated blood from Babesia-infected donors. According to the Centers for Disease Control and Prevention, the highest numbers of Babesia infections occurred in Massachusetts, New York, Connecticut, Rhode Island, New Jersey, Maine, New Hampshire, Wisconsin, and Minnesota.1

For further information, visit Grifols.

Reference

  1. Parasites: Babesiosis [online]. Atlanta: Centers for Disease Control and Prevention, 2018. Available at: www.cdc.gov/parasites/babesiosis. Accessed February 11, 2019.

Featured image: The Procleix Panther automated nucleic acid analyzer.