Spain-based healthcare firm Grifols has secured approval from the US Food & Drug Administration (FDA) for its ID Core XT molecular diagnostic test for in-vitro diagnostic (IVD) applications.
In 2014, the ID Core XT blood group genotyping kit secured CE- IVD approval in Europe.
Part of the BLOODchip product line, the ID Core XT test is produced by Grifols firm Progenika.
Grifols commercial diagnostic division president Carsten Schroeder said: “We are proud to welcome ID CORE XT to our family of FDA approved blood typing products and services.
“This test reinforces our commitment to provide high-quality solutions that improve transfusion medicine practices and patient care.”
The ID Core XT kit is useful for patients with ongoing transfusions, including individuals with hemoglobinopathies such as sickle-cell disease (SCD) and thalassemia.
Grifols’ kit can also be used for cancer patients who need more thorough blood typing and patients with warm autoimmune hemolytic anemia.
The ID Core XT holds capacity to type simultaneously 37 antigens of the blood group systems such as Rh, Kell, Kidd, Duffy, MNS, Diego, Dombrock, Colton, Cartwright and Lutheran.
The predicted antigen profiles will help build donor databases for the optimized management of antigen-negative units.
Grifols will market the test as a kit for use in the laboratory and as a send-out testing service at the Grifols Immunohematology Center in San Marcos, Texas.
The diagnostic kit uses polymerase chain reaction (PCR) technologies to amplify DNA samples, and can be combined with Luminex technology to precisely identify genetic markers that code for red blood cell antigens.
According to the company, the technology is easy to use and consists of few pipetting steps, enabling to take only 30 minutes hands-on-time and 4h from DNA to result.
Grifols has also secured FDA approval for its ID Core Control positive controls and BIDS XT software. BIDS XT is an advanced software that will hold database, help maintain the traceability and transfer data to the LIS.
FDA’s Center for Biologics Evaluation and Research director Dr Peter Marks said: “The approval of the ID CORE XT Test can streamline blood compatibility testing and provides an additional alternative to testing blood with antisera.”