FDA Clears Grifols’ Blood Screening Assay for Malaria

Grifols’ Procleix Plasmodium Assay, used in conjunction with the Procleix Panther System, has earned U.S. Food and Drug Administration approval 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. This mosquito-borne parasite 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,” Grifols Diagnostic President Antonio Martínez said. “The Procleix Plasmodium Assay enhances the ability of blood banks in the United States to provide safer blood transfusions.”

The Procleix Plasmodium Assay is a nucleic acid test (NAT) that uses magnetic-based target capture, Transcription-Mediated Amplification, and chemiluminescence to detect specific ribosomal RNA sequences of five Plasmodium parasite species 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 Procleix technology enable pathogen detection, reducing the risk of transfusing infected blood or blood components even when the donor does not exhibit symptoms and traditional screening techniques cannot detect the pathogen or antibodies against it. The assay runs on the Procleix Panther System, an automated NAT instrument.

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.

Grifols is a global healthcare company founded in Barcelona in 1909 that develops, produces, and provides plasma-derived medicines and transfusion medicine solutions and services in more than 110 countries.

Reference
¹ World Health Organization. Malaria Fact Sheet. https://www.who.int/news-room/fact-sheets/detail/malaria (Accessed February 26, 2026)