Company: GIFLF
Filing Date: 2025-04-11
Form Type: 20-F
Source: 0001104659-25-034245
Chunk: 103

Company: Grifols SA
Filing Date: 2025-04-11
Form: 20-F
Item: Item 4
Chunk 103
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 while also achieving regulatory approval in China for Eflexis, our flagship blood typing platform, in order to expand our geographic footprint. We also launched DC Scan Plus, a new DG Gel test under IVDR regulation that extends specificity beyond routine analytes and improves patient care by increasing sensitivity and specificity, thereby improving clinical patient management and outcomes in the field of donor screening. We also released new versions of our pooler software, as well as software to facilitate increased automation and ease of use for testing labs. Additionally, we launched in the United States the first-ever free direct-to-consumer program (consisting of an innovative and sophisticated genotyping test and service) to screen for the genetic risk of alpha1-antitrypsin deficiency (Alpha-1).
In 2024, the Diagnostics business unit continued to develop and introduce new high multiplex donor screening solutions to the market to drive efficiency improvements and address developing trends in transfusion-transmitted diseases. The team obtained CE mark approval for the Procleix ArboPlex Assay, which tests for four arboviruses: chikungunya virus RNA, dengue virus RNA, West Nile virus RNA and Zika virus RNA. The team also completed the U.S. clinical trials for the Ultrioplex W assay, which detects HIV-1, HIV-2, hepatitis C virus (“HCV”), hepatitis B virus (“HBV”), and West Nile virus (“WNV). Additionally, we completed U.S. clinical trials for the Procleix Plasmodium assay and developed a research use only (“RUO”) assay to screen for severe fever with thrombocytopenia syndrome virus (“SFTSV”) in an effort to address oncoming emerging pathogens. We are also developing new software to support new assay products on the Procleix donor screening platform, as well as to enable efficiency improvements to middleware solutions and increased productivity for our donor screening customers. In the field of blood typing, the Diagnostics business unit advanced development of a next generation blood typing platform, initiated development of an automated antisera program with extended phenotyping for the United States, and launched multiple innovative software releases across the instrument portfolio, including an automated titration method on Eflexis — all with the goal to increase efficiency and productivity for our customers. Additionally, the 2024 commercial success in Europe of our innovative blood typing interference solution for anti-CD38 antibody-treated patients has driven the pursuit of future expansion of this solution to the U.S. market. 
In 2024,