June 15, 2005

New Bead Array Technology Test System from BioArray Solutions Receives FDA Market Clearance

Warren, New Jersey, June 15, 2005/PR Newswire--BioArray Solutions, Ltd today announced the recent FDA 510(k) clearance of a novel immunoassay for the simultaneous detection of six antibodies to different extractable nuclear antigens (ENA). The ENA IgG BeadChip™ Test System, for use on the company’s Array Imaging System (AIS 400), utilizes BioArray Solutions’ 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, attesting to the viability of our novel array format in the clinical setting,” says Michael Seul, PhD, President of BioArray Solutions, Ltd. “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.”

About BioArray Solutions, Ltd.

BioArray Solutions, Ltd. is a molecular diagnostics company engaged in the development and commercialization of a flexible bead array format and automated assay delivery system to deliver proprietary BeadChip assay kits for application in immunohematology, transplantation, genetic testing, and other areas requiring the determination of sets of DNA and protein markers. More information about the Company and its technology can be found on its web site at www.BioArrayS.com.

Source: BioArray Solutions, Ltd. 06/15/2005.
Contact: Michael Seul, PhD, President of BioArray Solutions, Ltd.,
Website: www.BioArrayS.com
© 2005 BioArray Solutions, Ltd.