Fluxion Biosciences Introduces IsoFlux™ NGS Assay Kits for Circulating Biomarker Detection

22 Apr 2014
Sarah Thomas
Associate Editor

Product news

Fluxion Biosciences announced the introduction of a new series of assay kits design to enhance and complete the workflow for next-generation sequencing (NGS) using the IsoFlux System. The IsoFlux™ NGS assay kits are designed to work with circulating tumor material enriched on the IsoFlux System. They significantly increase the overall target purity of the sample and provide a robust nucleic acid extraction method that is optimized for next-generation sequencing. The IsoFlux NGS assay kits are available for immediate use through the IsoFlux Discovery Services program, with kit shipments to IsoFlux customers starting in June 2014.

Circulating tumor cells (CTCs) enable access to tumor material without the need for a surgical biopsy. CTCs possess the key advantage of being able to be enriched over the background blood cells, making it possible to analyze them using molecular methods. Other approaches to obtaining tumor material from the circulation, such as cell-free DNA, have limitations in this regard. Despite recent advances in CTC technologies, it remains a persistent challenge to enrich sufficiently to meet the rigorous requirements of next-generation sequencing platforms. The IsoFlux NGS assay kits incorporate a proprietary method of purity enhancement that, when combined with the IsoFlux System for primary enrichment, delivers a high purity DNA or RNA sample immediately ready for next-generation sequencing.

Next-generation sequencing plays an essential role in the emerging field of precision medicine. Clinical scientists have utilized NGS to learn how and why patients may respond or fail to particular therapies. They can employ NGS to learn how to best predict which therapies a patient might respond to over time. Timely access to tumor material has been the primary limitation to this approach. Serial tissue biopsy is not generally practiced due to the high risks, high costs, and limited success rates. The IsoFlux NGS kits provide a valuable tool to clinical scientists and drug developers to track the course of disease for an individual patient and as part of broader research studies. The IsoFlux NGS kits have been developed and validated with leading commercial NGS platforms and cancer mutation panels ranging from 5 to 500 genes of interest to cancer.

“The IsoFlux NGS assay kits deliver on the promise of where precision medicine is heading,” said Jeff Jensen, CEO at Fluxion. “The ability to analyze a broad range of cancer biomarkers in a single blood-based test provides critical information that will help inform the next generation of targeted therapies and diagnostics.”

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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.BiomarkersBiomarkers are biological markers which can be measured and evaluated to indicate a biological state. The use of biomarkers in research and diagnosis can indicate a normal or disease state or drug response of cells / tissues. Biomarkers include genetic markers, cell surface markers such as antigens, antibodies or receptors and secreted molecules such as cytokines. An assay system is required for identification of biomarkers. :Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.Clinical ChemistryBiochemistry (or clinical chemistry) involves the analysis of bodily fluids using chemical tests. Techniques used include HPLC, chromatography, spectroscopy, mass spectrometry, immunochemical, electrophoresis, turbidometric / spectrophotometric assay, MRI and ISE analysis. Tests are often carried out on plasma or serum but urine (urinalysis) and fecal specimens are also processed.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.Cancer DiagnosticsThere are a wide variety of diagnostic tests for cancer available, and this range continues to expand as our knowledge of cancer improves. Current diagnostic methods include biopsy, imaging and blood tests for known biomarkers. New methods in research development include liquid biopsies and cancer breathalyzers.Cancer ResearchAlthough cancer is often referred to as a single condition, it actually consists of more than 100 different diseases. Microscopy, mass spectrometry, high throughput sequencing and flow cytometry are some of the most common techniques employed in cancer research labs.Biomarker DiscoveryClinical biomarkers refer to substances related to known medical conditions that can be accurately measured <i>in vitro</i>. Biomarkers can be used to diagnose presence of a disease and indicate disease severity. The discovery of new biomarkers is incredibly valuable in the field of diagnostics.