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Illumina’s MiSeqDxTM Receives FDA Premarket Clearance with Two Cystic Fibrosis Assays and Universal Kit for Open Use

Premarket Clearance is an Industry First for a Next-Generation Sequencing System

SAN DIEGO--(BUSINESS WIRE)--Nov. 19, 2013-- Illumina, Inc. (NASDAQ:ILMN) today announced that it received premarket clearance from the U.S. Food and Drug Administration (FDA) for the MiSeqDx system, the first high-throughput DNA sequencing analyzer to receive FDA clearance. Illumina also received FDA premarket clearance for the MiSeqDx Cystic Fibrosis 139-Variant Assay, MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, and MiSeqDx Universal Kit.

The MiSeqDx benchtop sequencer offers users the ability to run diagnostic or research applications on a single, easy-to-use system. Designed and validated for the clinical market, the MiSeqDx with the portfolio of FDA-cleared in vitro diagnostic kits and assays leverage Illumina’s sequencing by synthesis (SBS) chemistry for high confidence in results.

The MiSeqDx Cystic Fibrosis 139-Variant Assay is designed for simultaneous detection of 139 clinically relevant disease-causing mutations and variants within the cystic fibrosis transmembrane conductance regulator (CFTR) gene. The assay includes all cystic fibrosis-causing variants recommended for carrier screening purposes by the American College of Medical Genetics and Genomics (ACMG) and the American College of Obstetricians and Gynecologists (ACOG).

The MiSeqDx Cystic Fibrosis Clinical Sequencing Assay leverages Illumina’s targeted resequencing chemistry to provide highly accurate sequencing data for the protein coding regions and intron/exon boundaries of the CFTR gene.

The MiSeqDx Universal Kit enables clinical laboratories to develop their own diagnostic tests. The kit includes library preparation reagents, sample index primers, and sequencing consumables needed for laboratories to develop amplicon assays on the in vitro diagnostic platform.

“Illumina is proud to be the first company to obtain FDA clearance for a high-throughput DNA sequencing analyzer and next-generation sequencing-based assays,” said Greg Heath, Senior Vice President and General Manager of Illumina’s Diagnostics business. “With the FDA clearance of the MiSeqDx, Illumina is providing clinicians and clinical laboratories with the tools needed to obtain comprehensive and reliable results from a DNA sequencing analyzer and enabling them to create and deploy NGS-based molecular diagnostic tests for cystic fibrosis and a wide-range of other applications.”

The MiSeqDx, MiSeqDx Cystic Fibrosis 139-Variant Assay, MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, and MiSeqDx Universal Kit are now available for immediate order with shipment before the end of 2013 in the United States and Europe. For more information, visit www.illumina.com/FirstNGSIVD.

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 may contain forward looking statements that involve risks and uncertainties. Important factors that could cause actual results to differ materially from those in any forward-looking statements 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.

Source: Illumina, Inc.

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