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Horizon Launches Quantitative Multiplex Genomic Reference Standards that Increase Precision and Utility of Molecular Assays for Cancer Genotype Screening

6 Mar 2013
Sarah Thomas
Associate Editor

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Horizon Diagnostics (HDx), a division of Horizon Discovery (Horizon), a leading provider of research tools to support the development and prescription of personalized medicines, today announced it has launched its first Quantitative Multiplex DNA Reference Standard. This standard is the first of its kind and is intended for researchers assessing multiple biomarkers in a single assay, using platforms such as next generation sequencing (NGS).

As multiplex assays and large tumor profiling projects become more common, standardization will be essential to enable confidence in experimental results. To date, a significant challenge has been access to reliable, renewable external reference standards. HDx’s novel Quantitative Multiplex DNA Reference Standard directly addresses this need by enabling researchers to quantify a range of detection thresholds for 11 cancer relevant mutations. This is accomplished across complex samples in a single assay in the form of renewable material originating from precisely engineered cell lines.

The reference standard is available today as genomic DNA and will be available in a matched formalin fixed paraffin embedded (FFPE) format in Q2, 2013. The mutations were engineered into endogenous loci using Horizon’s proprietary genome editing platform, GENESIS™.

HDx has verified the Quantitative Multiplex DNA Reference Standard using digital PCR and the product has undergone extensive validation by external partners using NGS platforms such as Ion Torrent™. Further validation is planned using MiSeq™ and Sequenom Mass Array™ Platforms.

“NGS workflows can be complex, typically involving extraction and amplification steps prior to sequencing and bioinformatic analysis. This gives scope for significant variability, which reduces confidence in the data generated, with the potential for some biomarkers being missed altogether,” Horizon’s VP of Products, Dr Paul Morrill, commented. “To date, HDx has been successful in enabling laboratories with reliable and renewable singleplex reference standards. With the development and launch of this new Multiplex Standard, HDx is better able to support customers as they address the complexity of tumor genetics, driving towards better understanding of disease and ultimately better patient care.”

HDx will be actively expanding its list of Multiplex Reference Standards over the coming months. The company is also open to working with clients seeking to develop custom standards with specific customer-defined genotypes and allelic frequencies.

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Other useful technologies for studying genomics include PCR, microarrays and electrophoresis.Flow Cytometry / Cell CountingFlow cytometers are used to count, sort and examine multiple characteristics of cells. Other cell analysis equipment includes image cytometers, cell counters, fluorescence-activated cell sorters (FACS), magnetic-activated cell sorters (MACS), and a range of flow cytometry assay kits. Flow cytometers can reveal information on cell viability, cell proliferation, apoptosis and cell cycle progression, as well as identify cell populations and intracellular or cell-surface molecules. Additionally, some flow cytometers, known as FACS, have an additional sorting function after analysis. Cell counters and image cytometers count live and dead cell populations and can also conduct cell proliferation assays. 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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. 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Horizon Launches Quantitative Multiplex Genomic Reference Standards that Increase Precision and Utility of Molecular Assays for Cancer Genotype Screening