Grifols receives FDA approval for its malaria blood screening assay

Barcelona, Spain, April 16, 2026 - Grifols (MCE: GRF, MCE: GRF.P NASDAQ: GRFS), a global healthcare company and leading producer of plasma-derived medicines and innovative diagnostic solutions, today announced that its Procleix Plasmodium Assay, used in conjunction with the Procleix Panther System, has obtained  approval from the U.S. Food and Drug Administration (FDA) for screening blood donors for malaria. 

The Procleix Plasmodium Assay received a CE mark in 2022 as the first automated nucleic acid test (NAT) specifically validated for screening blood donors for malaria. Its approval in the United States expands its use to support growing global demand and anticipated updates to regulatory requirements for donor screening.

The Procleix Plasmodium Assay aims to improve blood safety by detecting Plasmodium, a mosquito-borne parasite that causes malaria and is responsible for an estimated 282 million infections and 610,000 global deaths annually.[1]

The assay uses a whole‑blood sample and detects ribosomal RNA, which is present in thousands of copies per parasite. Currently, the risk of malaria infection in blood donors is assessed by blood banks using a questionnaire in which donors who report travel to, or prior residence in, malaria‑endemic areas are temporarily deferred.

"We are excited to announce the FDA approval of an additional Procleix blood screening assay, demonstrating Grifols' continued commitment to transfusion safety," said Antonio Martínez, president Grifols Diagnostic. "The Procleix Plasmodium Assay enhances the ability of blood banks in the United States to provide safer blood transfusions."

About the Procleix Plasmodium Assay

The Procleix Plasmodium Assay is a nucleic acid test (NAT) that uses magnetic-based target capture, Transcription-Mediated Amplification  and chemiluminescence to detect the presence of specific ribosomal RNA sequences of five species of Plasmodium parasites that cause malaria in humans (P. falciparum, P. knowlesi, P. malariae, P. ovale, and P. vivax) in whole blood specimens from blood donors.

The high sensitivity and specificity of the Procleix technology enables pathogen detection to reduce the risk of transfusing infected blood or blood components, even when the donor does not exhibit symptoms and traditional screening techniques are not able to detect the presence of the pathogen, or the antibodies against it. The assay runs on the widely adopted Procleix Panther System, an automated NAT instrument.

About Procleix Panther System

The Procleix Panther System automates all aspects of NAT-based blood screening on a single, integrated platform, and is capable of delivering the highest result throughput per square meter. It eliminates the need for batch processing and combines walk-away freedom with intuitive design for ease of use.

For more information, please visit www.diagnostic.grifols.com.