FDA Approves Grifols ID CORE XT Test For Molecular Red Blood Cell Typing

Barcelona, October 12, 2018 - 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 U.S. Food & 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 www.diagnostic.grifols.com

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) has also been granted FDA approval. BIDS XT is a unique software designed to hold a data-base, help maintain the traceability and transfer data to the LIS among other features.

Luminex is a trademark of Luminex Corporation.

¹ https://www.aabb.org/advocacy/reimbursementinitiatives/Documents/AABB-Endorsement-of-CPT-Tier-1-Code-for-Blood-Group-Genotyping.pdf
² https://www.cdc.gov/ncbddd/sicklecell/data.html
³ https://rarediseases.org/rare-diseases/thalassemia-major/
⁴ http://www.aabb.org/programs/publications/bulletins/Documents/ab16-02.pdf