Grifols won FDA approval for its automated malaria risk screening assay used with the Procleix Panther system. The Procleix Plasmodium Assay is a nucleic acid test for Plasmodium species (including P. falciparum, P. knowlesi, P. malariae, P. ovale, and P. vivax) from whole-blood donor samples, leveraging magnetic target capture and transcription-mediated amplification. The approval is notable because it formalizes a move away from questionnaire-only donor risk evaluation toward molecular screening. With CE marking secured earlier and a global infection burden cited by the company, the FDA action expands Grifols’ validated pathogen surveillance capability in blood services.