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FDA Committee Recommends Clearance for Immucor Blood-Typing Chip

NEW YORK (GenomeWeb News) – Immucor announced after the close of the market Tuesday that a US Food and Drug Administration committee has recommended that its platform for human erythrocyte antigen typing be cleared for clinical use.

The FDA's Blood Products Advisory Committee decided that Immucor's HEA Molecular BeadChip is "safe and effective" for typing HEA phenotypes in 35 blood group systems, the Norcross, Ga.-based company said.

Immucor submitted its pre-market approval application for the HEA Molecular BeadChip to the FDA last year. The company said the agency will take into account the committee's advice when deciding whether or not to clear the test. Immucor expects such a decision later this year.

Immucor sells a number of platforms for blood transfusion and transplantation diagnostics. As BioArray News has reported, the company gained its HEA Molecular BeadChip platform through its $117 million acquisition of Warren, NJ-based BioArray Solutions in 2008, and gained a CE-IVD mark for the test two years later, making it available for clinical use in Europe and other international markets.

In the US, though, the HEA Molecular BeadChip platform has been marketed for research use only. The company claims that 700,000 assays have been processed on the platform worldwide to date.

Immucor CSO Joanne Spadoro said in a statement that the firm was "pleased with the outcome" of the committee's meeting, noting that the company's chip is the "first molecular immunohematology test to be accepted for review by FDA." Spadoro added that the test could "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."