June 8, 2022

Grifols Procleix Plasmodium Assay receives CE mark, a first for malaria blood screening

  • Procleix Plasmodium Assay is a nucleic acid test (NAT) that detects the presence of Plasmodium, a protozoan parasite that causes malaria worldwide and creates a significant risk for both blood safety and availability
  • Screening blood donors with the assay can reduce the risk of transfusion-transmitted malaria (TTM) and enhance blood availability by reducing the number of donors rejected and deferred due to malaria risk
  • CE mark for the Procleix Plasmodium Assay further strengthens the Grifols Procleix portfolio for blood donor screening and is another example of the company’s commitment to safe blood transfusions globally

Barcelona, Spain, June 8, 2022 - Grifols (MCE: GRF, MCE: GRF.P, NASDAQ: GRFS), a global leader in the development of plasma-derived therapies and the development of innovative diagnostic solutions, today announced that its Procleix Plasmodium Assay has obtained the CE mark, the first for an automated nucleic acid test (NAT) system specifically validated for screening blood donors for malaria.

The Procleix Plasmodium Assay, designed for NAT, aims to improve blood safety by detecting Plasmodium, a mosquito-borne parasite that causes malaria and is responsible for more than 240 million infections and 620,000 deaths annually1.

This assay uses a whole blood sample and detects ribosomal RNA (rRNA), which is present in thousands of copies per parasite, allowing equivalent sensitivity in both individual and pooled samples. Currently, risk for malaria in blood donors is typically evaluated using a questionnaire in which donors who declare having traveled to or prior residence in malaria-endemic areas are temporarily deferred. Blood banks and collection centers could decide that deferrals could be unnecessary if donors were tested and found negative using the Procleix Plasmodium Assay.

“We are excited to announce the CE mark certification of an additional Procleix assay, demonstrating Grifols’ continued commitment to transfusion safety,” said Antonio Martínez, President, Grifols Diagnostic Business Unit. “Certification of the Procleix Plasmodium Assay enhances the ability of blood banks in Europe to provide safer blood transfusions.” 

The Procleix Plasmodium Assay will be available in all markets accepting the CE mark certification after completion of any additional registration and notification requirements.