Grifols said the FDA approved its automated Procleix Plasmodium Assay for screening blood donors for malaria risk. The assay is designed for use with the Procleix Panther system and detects Plasmodium species using a nucleic acid-based approach on whole-blood samples. The company previously held a CE mark and now gains FDA approval, broadening compliance capabilities for blood banks that currently rely on donor questionnaires to identify travel or residence in endemic areas. Regulatory approval strengthens the company’s position in blood-screening diagnostics and may support faster, more consistent malaria risk mitigation across donor populations.