Grifols Launches a New Testing Service for Patients Treated with Daratumumab

BARCELONA, Spain, May 31, 2018 /PRNewswire/ -- Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), one of the leading companies in the world in plasma-derived biological medicines and transfusion medicine, today announced it is adding a Daratumumab neutralization testing service to its extensive menu of services offered at Grifols Immunohematology Center laboratory (San Marcos, Texas). This new test facilitates complete antibody screening and identification in pretransfusion testing of patients under this therapy. The test is based on a soluble recombinant human CD38 that neutralizes the Daratumumab present in the plasma and eliminates its interferences with routine pretransfusion testing.

"This milestone is a testament to Grifols expertise in recombinant antigen research and development," said Carsten Schroeder, President, Grifols Diagnostic Division. "Continuing in our mission to deliver innovative transfusion medicine solutions, we are proud of this significant accomplishment that helps Daratumumab-treated patients receive better care."

Annually, there are more than 114,000¹ new cases of multiple myeloma. Daratumumab, a monoclonal antibody for the treatment of multiple myeloma, targets a protein (CD38) that often manifests on multiple myeloma and immune cells. CD38 monoclonal antibodies can result in interference with routine pretransfusion testing which can cause delays in providing Red Blood Cell units to patients receiving these agents. In January 2016, the AABB Clinical Transfusion Medicine Committee issued a bulletin² to provide background information and guidance on anti-CD38 interference, and recommendations for its prevention and treatment.  

Immunohematologists screening patients treated with Daratumumab now have access to blood group genotyping and the neutralizing assay, facilitating red cell antigen typing and alloantibody identification (including antibodies to antigens of the Kell, Dombrock, or Indian blood group systems), overcoming the limitations of DTT pretreated Red Blood Cells. With this new solution, there is no need to provide K-negative units to patients and offers the option to save units for those patients who really need them.

Grifols Immunohematology Center, a CLIA reference laboratory, offers extensive testing capabilities, expert consulting, and classroom and laboratory-based educational programs for transfusion medicine professionals. The lab's main focus is on analyzing some of the most complex cases related to donor and patient blood typing, alloimmunization and newborn hemolytic disease.

To learn more about the Daratumumab neutralization testing service, additional services offered at Grifols Immunohematology Center, as well as other innovative diagnostic solutions, please visit Grifols booth at the 35^th International Congress of the International Society for Blood Transfusion in Toronto, Canada on June 2-6, 2018 (booth #309) or visit Grifols website at [https://www.diagnostic.grifols.com].

About Grifols

Grifols is a global healthcare company with more than 75 years of legacy dedicated to improving the health and well-being of people around the world. Grifols produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to help them deliver expert medical care.

Grifols' three main divisions - Bioscience, Diagnostic and Hospital - develop, produce and market innovative products and services that are available in more than 100 countries.

With a network of 190 plasma donation centers, Grifols is a leading producer of plasma-derived medicines used to treat rare, chronic and, at times, life-threatening conditions. As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of diagnostic products designed to support safety from donation through transfusion. The Hospital Division provides intravenous (IV) therapies, clinical nutrition products and hospital pharmacy systems, including systems that automate drug compounding and control drug inventory.

Grifols is headquartered in Barcelona, Spain and has 18,300 employees in 30 countries.

In 2017, sales exceeded 4,300 million euros. Grifols demonstrates its strong commitment to advancing healthcare by allocating a significant portion of its annual income to research, development and innovation.

The company's class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the US NASDAQ via ADRs (NASDAQ:GRFS).

For more information, visit www.grifols.com

¹https://www.wcrf.org/int/cancer-facts-figures/worldwide-data
²https://www.aabb.org/programs/publications/bulletins/Documents/ab16-02.pdf

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SOURCE Grifols