Illumina, Inc. (NASDAQ:ILMN) today 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. For more information, visit www.illumina.com/MiSeqDxPlatform.About Illumina Illumina ( www.illumina.com) is a leading developer, manufacturer, and marketer of life science tools and integrated systems for the analysis of genetic variation and function. We provide innovative sequencing and array-based solutions for genotyping, copy number variation analysis, methylation studies, gene expression profiling, and low-multiplex analysis of DNA, RNA, and protein. We also provide tools and services that are fueling advances in consumer genomics and diagnostics. Our technology and products accelerate genetic analysis research and its application, paving the way for molecular medicine and ultimately transforming healthcare. Forward-Looking Statements This release contains forward-looking statements that involve risks and uncertainties. Examples of forward-looking statements include, but are not limited to, statements we make regarding the expected order availability date. Important factors that could cause actual results to differ materially from those in any forward-looking statements include challenges inherent in developing and launching new products and services and the other factors that are detailed in our filings with the Securities and Exchange Commission, including our most recent filings on Forms 10-K and 10-Q, or in information disclosed in public conference calls, the date and time of which are released beforehand. We do not intend to update any forward-looking statements after the date of this release.