BioArray Solutions

NEW YORK (GenomeWeb) — Immucor believes the recent US regulatory approval of its microarray-based PreciseType Human Erythrocyte Antigen test for determining blood compatibility will encourage more customers to introduce the assay in a clinical setting.

US patents awarded to Nishikawa Rubber, Virco, Bioarray Solutions, Aisin Seiki, Riken, Abacus Diagnostica, Sigma-Aldrich, Illumina, LLNL, OncoMedX, Brandeis University, and Epigenomics.

BioArray Solutions, DuPont, and Becton Dickinson awarded US patents.

CEO Gioacchino De Chirico said the postponement will have no impact on the timing of Immucor's plan to submit the system to the US Food and Drug Administration for clearance.

While the assay has been available for research use in Europe, the company believes its certification as an in vitro diagnostic will allow more users in blood banks, clinical laboratories, and blood donor centers to adopt the technology.

The company expects to obtain a CE-IVD mark for its semi-automated BeadChip array analysis system this quarter and to make a new, fully automated version of the molecular immunohematology system available for research purposes in the first half of 2011.

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