) 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.
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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
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
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
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