FDA Approves Grifols ID CORE XT Test For Molecular Red Blood Cell Typing
BARCELONA, Spain /PRNewswire/ -- Grifols (MCE: GRF, MCE: GRF.P and NASDAQ: GRFS), a leading global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, received approval from the Food and Drug Administration (FDA) for its ID CORE XT molecular diagnostic test for in-vitro diagnostic (IVD) use in the United States. The blood group genotyping kit has been CE-IVD marked in Europe since 2014.
"We are proud to welcome ID CORE XT to our family of FDA approved blood typing products and services," said Carsten Schroeder, President of Grifols Commercial Diagnostic Division. "This test reinforces our commitment to provide high-quality solutions that improve transfusion medicine practices and patient care."
Molecular red blood cell typing provides significant advantages to patient and in donor management. Individuals requiring frequent transfusions are at a higher risk of receiving incompatible blood, which can result in life-threatening and costly adverse reactions1.
The ID CORE XT kit will benefit patients who require ongoing transfusions including individuals with hemoglobinopathies such as sickle-cell disease (SCD) and thalassemia. SCD affects approximately 100,000 Americans and is a major health concern in the U.S.2 Beta-thalassemia affects approximately one in 100,000 individuals worldwide.3
The kit will also be used for cancer patients who require more thorough blood typing. Other patients who may benefit from the kit include those with warm autoimmune hemolytic anemia, those who have recently received a transfusion and those undergoing daratumumab therapy.1,4
ID CORE XT types simultaneously 37 antigens of the following blood group systems: Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright and Lutheran, providing detailed information of the most clinically relevant blood groups. The predicted antigen profiles are used to build donor databases for the optimized management of antigen-negative units that are often needed to support the above mentioned patients.
The test will soon be available from Grifols as a kit to be used in the laboratory and as a send-out testing service from the Grifols Immunohematology Center in San Marcos, Texas.
For more information about Grifols Diagnostic Division visit diagnostic.grifols.com/IDCOREXT.
About ID CORE XT
ID CORE XT is an integral part of the BLOODchip product line, manufactured by Progenika, a Grifols company. The diagnostic kit uses Polymerase Chain Reaction (PCR) technologies to amplify DNA samples, and, combined with Luminex® technology, permits the precise identification of the genetic markers that code for red blood cell antigens. The technology is easy to use, consisting on few pipetting steps, taking only 30 minutes hands-on-time and 4h from DNA to result.
In addition to ID CORE XT, the positive controls (ID CORE CONTROL) and proprietary software (BIDS XT) have also been granted FDA approval. BIDS XT is a unique software designed to hold a database, help maintain the traceability and transfer data to the LIS among other features.
Luminex is a trademark of Luminex Corporation.
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 approximately 250 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 20,000 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 grifols.com.
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Company Codes: NASDAQ-NMS:GRFS, SpanishCats:GRF, OTC-PINK:GIKLY, SpanishCats:GRF.P