IVD Device Simultaneously Detects Multiple Analytes in DNA Sample

(San Diego, CA, USA) announced that the U.S. Food and Drug Administration (FDA; Silver Spring, MD, USA) granted 510(k) market clearance for the company's BeadXpress system for multiplex genetic analysis. According to the FDA's indications of use, the BeadXpress system, consisting of Illumina's BeadXpress Reader and VeraScan software can now be used for IVD purposes.

The BeadXpress system was originally introduced by Illumina for research only for custom genotyping, gene expression, methylation, and protein analysis. It has been adopted since then by research, agricultural, industrial, and pharmaceutic institutions worldwide.

Jay Flatley, president and CEO of Illumina, in a reference to the FDA approval, said, "It demonstrates Illumina's ability to meet stringent regulatory requirements in designing and manufacturing an FDA-cleared in-vitro diagnostic device. This will serve as an important foundation for our future plans in the diagnostics area. Ultimately, our goal is to become a leader in translational medicine, focusing on complex diseases that benefit from high performance analysis, including genotyping, copy number, gene expression, methylation and protein analysis."

Illumina is a developer, manufacturer, and marketer of integrated systems for the analysis of genetic variation and biological function.

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Illumina, Inc.
U.S. Food and Drug Administration