Illumina has received FDA 510(k) market clearance for 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 is an in-vitro diagnostic device intended for the simultaneous detection of multiple analytes in a DNA sample utilizing VeraCode holographic microbead technology.
Reportedly, Illumina had introduced the BeadXpress system in 2007 with Research Use Only kits for custom genotyping, gene expression, methylation and protein analysis.
Since then it has been adopted by research, agricultural, industrial and pharmaceutical institutions worldwide. Utilizing inscribed digital microbeads, VeraCode technology provides high-quality data, broad multiplexing capability and assay flexibility. Illumina submitted the system for FDA review in September 2009.
Jay Flatley, president and CEO, said: “This approval represents a significant and exciting transitional step for Illumina into the diagnostics field, where the potential is great for molecular medicine to make a real difference in the way disease is detected and ultimately prevented and treated.
“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.”
Gregory Heath, senior vice president and general manager of Diagnostics, said: “510(k) clearance opens up a wide range of new possibilities for our many clinical research and commercial partners, who can now pursue diagnostic development on our proven, high-performance BeadXpress platform.”