Seek Flexibility for your Molecular Laboratory

4 Dec 2013
Sonia Nicholas
Managing Editor and Clinical Lead

Product news

Bring the benefits of next-generation sequencing (NGS) into the clinical lab with the first and only FDA-cleared NGS system for in vitro diagnostic use.

Illumina is the leading provider of accurate, reliable NGS solutions. Now clinical laboratories can take advantage of powerful NGS technology with the MiSeqDx system.

The MiSeqDx instrument is the first and only FDA-cleared in vitro diagnostic (IVD) next-generation sequencing system. Designed specifically for the clinical laboratory environment, the MiSeqDx instrument offers a small 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.

Currently, three ready-to-use kits and assays are available for use on the MiSeqDx system:

• MiSeqDx Universal Kit
o Develop your own diagnostic tests.

• MiSeqDx Cystic Fibrosis 139-Variant Assay
o The largest panel of clinically relevant and functionally validated variants for cystic fibrosis testing

• MiSeqDx Cystic Fibrosis Clinical Sequencing Assay
o An NGS test providing a comprehensive view of the CFTR gene.

The MiSeqDx instrument provides you maximum flexibility in your clinical lab.

Learn more by following the company website link below or click here for more information on the MiSeqDx platform.


Download the Cystic Fibrosis paper and learn more about the clinical significance of testing more variants when determining CF carrier status >> Download the paper

Download the New England Journal of Medicine Article ‘First FDA Authorization for Next-Generation Sequencer’ >> Download the paper



* Report generation is only available for the MiSeqDx Cystic Fibrosis 139-Variant Assay and MiSeqDx Cystic Fibrosis Clinical Sequencing Assay.

For In Vitro Diagnostic Use. Contact an Illumina representative for regional availability.

Links

Tags

Genome AnalysisGenomics, the study of genomes, includes functional genomics, evolutionary genomics and comparative genomics. There are many genomic technologies such as DNA sequencing of whole genomes, computational biology and bioinformatics. DNA and nucleic acids must be isolated and concentrated from cells for analysis with kits, automated analyzers and software. Other useful technologies for studying genomics include PCR, microarrays and electrophoresis.DNA SequencingDNA sequencing, such as sanger sequencing, is a biological technique that determines the precise order of nucleotide bases in a fragment or template of DNA. DNA sequencers and genetic analyzers are based on capillary electrophoresis, where labeled DNA fragments are electrophoretically separated by size as they migrate through a polymer. Find the best DNA sequencing products, including DNA sequencing kits, genomic libraries and genetic identity kits in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Clinical GeneticsMolecular Genetics covers the analysis of hereditary genetic disease and chromosomal abnormalities. Genetics can be analysed using DNA, RNA, and protein microarrays, PCR, RT PCR and DNA sequencing. Genetic equipment includes genetic workstations, thermal cyclers, cooling blocks and electrophoresis products. Diagnostic kits are used for DNA / RNA extraction and purification.Next Generation SequencingNext-generation sequencing (NGS), also known as whole-genome sequencing, high-throughput sequencing and massive parallel sequencing, produces and analyses thousands to millions of nucleotide sequences at once. Sequencing systems operate via varying technologies depending on the manufacturer, including sequencing by synthesis, ligation, pyrosequencing, ion semiconductor and single-molecule real-time sequencing. For NGS, library preparation is paramount to successful sequencing. In this section, explore a range of library preparation kits, from targeted, amplicon-based or hybridization-based kits including epigenomic, transcriptomic and genomic workflows to fragmentation kits. Find the best next-generation sequencing products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Clinical NGSNext Generation Sequencing (NGS) refers to the use of massive parallel sequencing of multiple small fragments of DNA. This high-throughput genomic analysis yields enormous amounts of sequence data, which if appropriately analyzed could have huge potential for clinical laboratories. For this to happen there are technique and bioinformatic hurdles to be overcome.