New Bead Array Technology

The immunoassay has been cleared by the U.S. Food and Drug Administration (FDA).

The ENA IgG BeadChip test system of BioArray Solutions, Ltd. (Warren, NJ, USA), is for use on the company's Array Imaging system (AIS 400) and utilizes the company's proprietary BeadChip format to simultaneously detect multiple analytes of interest on a tiny silicon chip holding a planar array of color-encoded microparticles. The AIS 400 fully automates image acquisition and integrated analysis to rapidly generate assay results.

"Receiving FDA clearance for this test system represents an important milestone for BioArray Solutions,” observed Michael Seul, Ph.D., president of BioArray Solutions. "Additional products for protein as well as DNA analysis, currently under development, also use the AIS 400 and BeadChip format, offering clinical laboratories the benefit of a universal test platform that supports a diverse menu of applications to enhance laboratory capabilities and productivity.”

BioArray Solutions delivers proprietary BeadChip assay kits for application in immunohematology, transplantation, genetic testing, and other areas requiring the determination of sets of DNA and protein markers.




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