FDA Panel Recommends Clearance For Immucor (BLUD) Blood-Typing Chip
3/19/2014 9:12:04 AM
FDA Advisory Committee Unanimously Recommends Approval of Immucor's HEA Molecular BeadChip(TM) Test
NORCROSS, Ga., March 18, 2014 (GLOBE NEWSWIRE) -- Immucor, Inc., a global leader in transfusion and transplantation diagnostics, today announced that the Blood Products Advisory Committee (BPAC) of the U.S. Food and Drug Administration (FDA) unanimously voted to recommend approval of Immucor's HEA Molecular BeadChip™ Test as safe and effective for the molecular typing of human erythrocyte antigen (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 a mutation (HgbS 173 A > T) in the Beta Globin gene. More than 700,000 tests have been processed with Immucor's HEA assay worldwide.
"We are pleased with the outcome of today's BPAC meeting for our HEA BeadChip product, which represents the first molecular immunohematology test to be accepted for review by FDA," stated Joanne Spadoro, PhD, Immucor's Chief Scientific Officer and Vice President of Research and Development. "Molecular methods are intended to provide additional information regarding the composition of donor and patient blood, which may result in better matches, especially for multi-transfused patients, such as those suffering from cancer and sickle cell disease."
Immucor submitted its Pre-Market Approval (PMA) application to the FDA in June 2013 for the HEA Molecular BeadChip Test. The FDA will take into account the BPAC's advice in making its decision on whether to approve the HEA BeadChip Test for blood group typing in the United States. The Company expects a decision on approval later this year.
The BPAC reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood, products derived from blood and serum or biotechnology that are intended for use in the diagnosis, prevention, or treatment of human diseases, and, as required, any other product for which the FDA has regulatory responsibility, and advises the Commissioner of Food and Drugs of its findings.
Founded in 1982, Immucor is a global leader in transfusion and transplantation diagnostics that facilitate patient-donor compatibility. Our mission is to ensure that patients in need of blood, organs or stem cells get the right match that is safe, accessible and affordable. With the right match, we can transform a life together. For more information on Immucor, please visit our website at www.immucor.com.
Cautionary Note Regarding Forward-Looking Statements
Certain statements contained in this communication contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, including, among others, statements regarding potential FDA approval of the HEA BeadChip test are forward-looking statements. Forward-looking statements are not guarantees of future events and involve risks and uncertainties that actual events may differ materially from those contemplated by such forward-looking statements. Factors that may cause actual results to differ materially include those set forth in the reports that the Company files from time to time with the SEC, including its annual report on Form 10-K for the year ended May 31, 2013. These forward-looking statements reflect the Company's expectations as of the date hereof. The Company undertakes no obligation to update the information provided herein.
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