FDA Go-Ahead for Illumina's Offerings


Illumina, Inc. (ILMN) announced its receipt of the premarket clearance from the U.S. Food and Drug Administration (:FDA) for the MiSeqDx system as well as the MiSeqDx Cystic Fibrosis 139-Variant Assay, MiSeqDx Cystic Fibrosis Clinical Sequencing Assay, and MiSeqDx Universal Kit.

MiSeqDx system is the first high-throughput DNA sequencing analyzer to receive the FDA clearance. TheMiSeqDx Platform is a sequencing instrument that is designed for targeted re-sequencing of human genomic DNA from peripheral whole blood samples.

The MiSeqDx benchtop sequencer allows clinical and research-based applications to be executed on a single easy-to-use system. The device is accompanied by the MiSeqDx Universal Kit, which includes library preparation reagents, sample index primers, and sequencing consumables needed for laboratories to develop amplicon assays on the in vitro diagnostic platform.

The availability of the Kit along with the instrument guarantees superior performance outcomes for clinical laboratories intending to develop their own diagnostic tests, facilitating its use in a variety of diagnostic applications. Illumina expects this revolutionary device to gain wide market acceptance in the long run.

The MiSeqDx Cystic Fibrosis 139-Variant Assay is a qualitative in vitro diagnostic device that helps to detect 139 clinically relevant disease-causing mutations and variants in the cystic fibrosis transmembrane conductance regulator (:CFTR) gene. The gene and the mutations included in the assay for screening are recommended by the American College of Medical Genetics and Genomics (ACMG) and the American College of Obstetricians and Gynecologists (:ACOG). This medical instrument promises highly accurate sequencing data.

Management at Illumina welcomes the FDA approval and believes it will further the company’s scope to provide clinicians with reliable tools to devise next-generation sequencing (NGS) molecular diagnostic tests for cystic fibrosis and other applications.

All four products are expected to be available for shipment before the end of 2013, both in the United States and in Europe.

Currently, Illumina carries a Zacks Rank #2 (Buy). Stocks that are also worth considering include Actelion Ltd. (ALIOF), AMAG Pharmaceuticals, Inc. (AMAG) and Vanda Pharmaceuticals, Inc. (VNDA). All these stocks carry a Zacks Rank #1 (Strong Buy).

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