BioArray Solutions of NJ get FDA clearance

(from GenomeWeb news) - BioArray Solutions has received clearance from the FDA for a bead array-based multiplexed immunoassay, the Warren, NJ-based company said today. The 510(k) clearance covers the company's IgG BeadChip test system, an immunoassay for the simultaneous detection of six antibodies to different extractable nuclear antigens. The test will be used with BioArray's Array Imaging System, AIS 400, which employs a chip format for detection. BioArray Solutions is currently developing other assays for protein and DNA analysis to run on its platform.

BioBOOM Op/Ed: We saw this interesting company at the ASH meeting and wondered how it was dealing with this Luminex or Illumina like process and IP as they were postioning for the clinical diagnostic market. Seems they have now a good regulatory approach with this approval. There are other systems out there coming such as Autogenomics, Ambion Diagnostics, BioRad, Eppendorf, Eragen and others which should also help create more choices for standardized multiplex processing in the clinical market. Plus they present competitive challenges to players such Affy, Third Wave, Nanogen and TM Biosciences

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