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Home Industry News FDA approval for Grifols ID Core XT Molecular diagnostic test

FDA approval for Grifols ID Core XT Molecular diagnostic test

23rd October 2018

FDA has given Grifols approval for its ID core XT molecular diagnostic test as part of its BLOODchip product line. The kit is for patients with ongoing transfusions, and can be used for patients suffering with cancer who need more thorough blood typing. It has a capacity to hold 37 antigens of blood group systems simultaneously, and will help build donor databases.
“The ID Core XT reinforces our commitment in improving transfusion medicine practices,“ comented Division President Cartsen Schroeder, “We are very pleased to welcome this test to our family of blood typing products and services.”
With the kit only taking 30 minutes hand on time, and four hours from DNA to result, the kit is considered by the company easy to use. It uses polymerase chain reaction technologies to amplify DNA samples and identify genetic markers that code for red blood cell antigens through the combination of Luminex technology.

FDA’s Centre 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.”

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