Grifols won US FDA approval for a nucleic-acid-based assay to screen blood donors for malaria risk. The Procleix Plasmodium Assay is automated on the Procleix Panther system and detects ribosomal RNA sequences from five Plasmodium species using whole-blood samples. The company’s approach replaces or augments questionnaire-based screening by adding a laboratory test designed to identify parasite presence in donors, including P. falciparum, P. knowlesi, P. malariae, P. ovale, and P. vivax. The assay previously held CE marking in 2022. This is a direct operational upgrade for blood safety workflows and adds regulatory momentum to molecular screening platforms in transfusion medicine.