Grifols Procleix UltrioPlex E and Procleix Babesia assays receive CE mark

Barcelona, Spain, March 25, 2021 - Grifols (MCE: GRF, MCE: GRF.P, NASDAQ: GRFS), a global leader in the development of plasma-derived therapies and in the development of innovative diagnostic solutions, today announced it has obtained the CE mark for its Procleix UltrioPlex E and Procleix Babesia assays.

The Procleix UltrioPlex E Assay is a nucleic acid test (NAT) designed to improve blood safety by detecting the presence of human immunodeficiency virus type 1 (HIV-1), HIV type 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and hepatitis E virus (HEV) in a single, simultaneous test from human serum or plasma. It was first commercially launched in August 2020 in Japan and represents a significant advance in streamlining a laboratory’s NAT testing operations by allowing for an increased screening of viruses from a single-donor specimen without the need for any additional equipment. The Procleix UltrioPlex E Assay also helps produce less waste with higher results throughput and greater walk-away time for laboratory staff when compared with running current screening solutions separately.

The Procleix Babesia Assay detects Babesia, a tick-borne parasite that infects the host’s red blood cells and is responsible for one of the most frequent causes of non-viral TTI. It is the first Procleix assay to use a whole blood specimen and, most importantly, target a parasite instead of a virus. The detection of ribosomal RNA, which is present in thousands of copies per parasite, allows equivalent sensitivity in individual samples and pooled lysates. Screening of donated whole blood to detect the presence of the four most common Babesia species is currently mandated in certain parts of the United States where the pathogen represents a serious threat to the safety of the blood supply.

“We are excited to announce the CE mark of two additional assays, as part of our Procleix portfolio for screening blood and plasma, demonstrating Grifols’ continued commitment to transfusion safety,” said David Dew, President, Grifols Diagnostic Commercial Division. “Certification of the Procleix UltrioPlex E and Procleix Babesia assays enhances the competitiveness of our Procleix portfolio and enables blood banks in Europe to increase transfusion safety.”

The Procleix UltrioPlex E and Procleix Babesia assays will be available in all markets accepting the CE mark after completion of any additional registration and notification requirement.

About Procleix UltrioPlex E Assay

The Procleix UltrioPlex E Assay is a nucleic acid test (NAT) that uses Transcription-Mediated Amplification (TMA) to detect the presence of specific nucleic acid sequences for HIV-1, HIV-2, HBV, HCV, and HEV in serum or plasma of donated blood. Because of the high sensitivity and specificity of the amplification technology, detection of the targeted pathogens can be achieved within the early stages of infection, thereby helping in preventing infected blood or blood components to be transfused 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 Procleix Panther System, a fully automated NAT instrument launched by Grifols in the EU market in 2012, and currently widely adopted in laboratories globally.

About Procleix Babesia Assay

The Procleix Babesia Assay is a nucleic acid test (NAT) that uses Transcription-Mediated Amplification (TMA) to detect the presence of specific ribosomal RNA sequences of at least four clinically relevant species of Babesia parasites (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens from blood donors. Because of the high sensitivity and specificity of the amplification technology, detection of the pathogen can be achieved within the early stages of infection, thereby helping in preventing infected blood or blood components to be transfused 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 Procleix Panther System, a fully automated NAT instrument launched by Grifols in the EU market in 2012, and currently widely adopted in laboratories globally.