Illumina Applies CE Mark to Expanded MiSeqDx™ System
25 Sept 2013Product News
Illumina, Inc. has announced that it declared conformity with the requirements of the IVD Directive and has applied the CE mark to expand the use of the MiSeqDx system in clinical laboratories. These laboratories are now able to develop diagnostic tests using Illumina's new MiSeqDx Universal Kit on the MiSeqDx. The MiSeqDx Universal Kit joins the MiSeqDx Cystic Fibrosis Carrier Screening Assay and the MiSeqDx Cystic Fibrosis Diagnostic Assay in Illumina's expanding line of clinical products available for the MiSeqDx.
The MiSeqDx uses Illumina's industry-leading sequencing by synthesis chemistry, the sequencing technology most widely adopted by genetics researchers worldwide. The instrument offers users the ability to run diagnostic or research applications on a single, easy-to-use system. The MiSeqDx Universal Kit includes the library preparation reagents, sample index primers, and sequencing consumables needed for laboratories to develop amplicon assays on an in vitro diagnostic platform.
"The MiSeqDx demonstrates Illumina's continuing commitment to the clinical adoption of next-generation sequencing technologies. The company's validated products provide reliability and flexibility to our clinical customers," said Greg Heath, Senior Vice President and General Manager of Illumina's Diagnostics business. "The MiSeqDx greatly expands the opportunity for clinical laboratories to offer diagnostic tests for wide-ranging applications including genetic and infectious diseases and cancer."
The new functionality for the MiSeqDx, enabled by the MiSeqDx Universal Kit, will be commercialized in a number of European countries that require the CE mark, and will begin shipping in Europe beginning in November 2013.
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MiSeqDx System
IlluminaThe MiSeqDx instrument is the first and only FDA-cleared in vitro diagnostic (IVD) next-generation sequencing (NGS) system. Designed specifically for the clinical laboratory environment, the MiSeqDx instrument offers a small, approximately 4 square feet (0.37 square meters) footprint, an easy-to-follow workflow, and data output tailored to the needs of clinical labs. In addition, the integrated software enables sample tracking, user traceability, and results interpretation.Taking advantage of proven Illumina sequencing by synthesis (SBS) chemistry, the MiSeqDx instrument provides accurate, reliable screening, and diagnostic testing.MiSeqDx System Features & Benefits: First and Only FDA-cleared IVD NGS System - As an FDA-cleared IVD system, the MiSeqDx instrument meets guaranteed performance characteristics so you can feel confident that you are generating accurate and reliable data. Simple NGS Workflow - The compact, all-in-one instrument incorporates cluster generation, paired-end fluidics, sequencing by synthesis chemistry, and complete data analysis. Enhanced User Security - Equipped with Illumina User Management Software that enables laboratories to control and trace system access, ensuring that only authorized personnel are running tests. Proven, Well-Published Technology - The most widely adopted NGS technology worldwide, with references in more than 3,300 peer-reviewed publications. The MiSeqDx system uses the same proven reversible-terminator SBS chemistry used by all Illumina sequencing platforms. User-Friendly, Intuitive Software - The first IVD NGS to offer a fully integrated sequencing ecosystem. Instrument software is accessed through a user-friendly touch screen interface. For In Vitro Diagnostic Use. Contact an Illumina representative for regional availability.