Diagnostic solutions company Grifols (MCE:GRF) (MCE:GRF.P) (NASDAQ:GRFS) reported on Friday the receipt of US Food & Drug Administration (FDA) approval for its ID CORE XT molecular red blood cell typing kit for in-vitro diagnostic (IVD) use in the US laboratories.

Concurrently, the ID CORE XT kit test will soon be available as a send-out testing service from the Grifols Immunohematology Center in San Marcos, Texas. The technology is easy to use, consisting on few pipetting steps, taking only 30 minutes hands-on-time and 4h from DNA to result, added the company.

According to the company, the blood group genotyping kit has been CE-IVD marked in Europe since 2014.

The company said molecular red blood cell typing provides advantages to patient and in donor management. The kit will be used for cancer patients who require more thorough blood typing as well as for patients with warm autoimmune hemolytic anemia who have received a transfusion and those undergoing daratumumab therapy.

Grifols added that its ID CORE XT kit will benefit patients who require ongoing transfusions including individuals with hemoglobinopathies including sickle-cell disease (SCD) and thalassemia. SCD affects 100,000 Americans and is a major health concern in the U.S. Beta-thalassemia affects one in 100,000 individuals worldwide.

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 needed to support the patients. 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, concluded the company.