NEW YORK (GenomeWeb) — Grifols said today that it has received US Food and Drug Administration approval for its Procleix assay for the detection of Babesia, a malaria-like parasite that can be transmitted through tick bites and donated blood.
The test is designed to detect ribosomal RNA from four clinically relevant Babesia species — B. microti, B. duncani, B. divergens, andB. venatorum — in individual samples or up to 16 pooled lysed specimens from human donors, including donors of whole blood and blood components for transfusion. It is designed to run on the Barcelona, Spain-based company's fully automated Procleix Panther system, which performs nucleic acid testing for blood screening.
Grifols said that the approval follows the successful completion of a multicenter clinical trial performed under an investigational new drug study at the American Red Cross, Creative Testing Solutions, and Rhode Island Blood Center.
"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," Carsten Schroeder, president of Grifols' diagnostic commercial division, said in a statement.
Last year, the FDA approved Grifols' Procleix Zika virus assay, Procleix WNV West Nile virus assay, and Procleix Ultrio Elite combination HIV-1, hepatitis B, and hepatitis C assay.