FDA
20th March 2014

FDA Panel Recommends Immucor Test for Approval

Yesterday, the Blood Products Advisory Committee unanimously recommended approval of BioArray Solutions’ (An Immucor company) HEA Molecular BeadChip Test.

FDA Panel Recommends Immucor Test for Approval

Yesterday, the Blood Products Advisory Committee unanimously recommended approval of BioArray Solutions’ (An Immucor company) HEA Molecular BeadChip Test; finding the test to be safe and effective for typing HEA phenotypes in 35 blood group systems. 

Immucor’s HEA test, which received CE Mark in July 2010 and is commercially available in Europe and other international markets, is currently available for Research Use Only in the United States. The HEA BeadChip product is an in vitro diagnostic test and is Immucor’s core molecular test for extended typing of red blood cell antigens from a DNA sample. The product is designed to predict the phenotypes of the Rh (C,c,E,e), Kell (K, k, Kpa, Kpb, Jsa, Jsb), Duffy, Kidd, MNS, Lutheran, Dombrock (Doa, Dob, Hy, Jo), Landsteiner-Wiener, Diego, Colton, and Scianna blood group systems. The test is also designed to detect mutations (HgbS 173 A > T) in the Beta Globin gene. More than 700,000 tests have been processed with Immucor’s HEA assay worldwide.

This test will be able to provide additional information about the composition of donor and patient blood, which may result in better matches for blood transfusion patients, especially for those who have received multiple transfusions.

Immucor submitted its Pre-Market Approval (PMA) application to the FDA in June 2013 for the HEA Molecular BeadChip Test. It is the first molecular immunohematology test the FDA has accepted for review.

The FDA will take into account the panel’s advice in making its decision on whether to approve the HEA BeadChip Test for blood group typing in the United States; however, they are not bound to the decision. A decision on approval is expected to come later this year.

 

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

Do you want a more detailed analysis of this device’s FDA AdComm meeting? Great news – ISS can help you! Click on the link below in order to receive a detailed post-meeting outcome report!

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