Cambridge, UK, and Boulder, CO, USA, 23rd March 2015... Horizon Discovery Group plc (LSE:HZD) , the international life science company supplying research tools and services that power genomics research and the development of personalised medicines, and ArcherDX, Inc., a leader in Next Generation Sequencing (NGS) fusion detection, today announced they have signed an Original Equipment Manufacture (OEM) agreement that will see Horizon’s Reference Materials supplied as a standalone product alongside ArcherDX’s Archer™ FusionPlex™ to aid customer validation of its ALK fusion assay kits.
The agreement is a further endorsement of the demand in the translational sequencing market for accurate and reliable reference material to validate sample testing. Horizon’s reference materials will be available for sale alongside Archer™ FusionPlex™ ALK fusion tests that can run on both Illumina® and Ion Torrent™ next-generation sequencing platforms, a fast-growing market that represented $2.5 billion in 2014 and Horizon anticipates that the Archer assay will prove to be well received by the market. Further financial details of the deal were not disclosed.
The Archer™ FusionPlex™ ALK, RET, ROS1 Panel simultaneously detects and identifies both known and previously unidentified fusions and mutations of human ALK, RET and ROS1 (c-ros oncogene 1) genes from tumour samples, including formalin fixed paraffin embedded (FFPE) preserved specimens.
ALK fusions of genetic markers ALK, RET, ROS1, are found in approximately 3–7% of lung tumours and are an important clinical marker for non-small cell lung cancer. The anti-cancer drug Crizotinib, marketed by Pfizer, acts as an ALK and ROS1 inhibitor and is approved to treat certain late-stage non-small cell lung cancers that express the abnormal anaplastic lymphoma kinase (ALK) gene, alongside an approved companion diagnostic. It is therefore essential to have accurate and reliable molecular diagnostic testing prior to beginning therapy.
Horizon’s Reference Materials offer a high quality, sustainable source of independent external controls to laboratories, proficiency schemes and manufacturers, providing an unprecedented level of control. The reference materials include standards for the increasing number of ‘rare’ mutations being targeted for cancer therapeutics, which by definition are hard to find in clinical samples.
Dr Paul Morrill, President, Products Business, Horizon Discovery Group, said: “Our agreement with Archer is a recognition of the importance of providing controls alongside a targeted sequencing assay, and as an important OEM agreement is a milestone for Horizon. We are delighted that ArcherDX has chosen to include our HDx Reference Material alongside their assay kits.”
Dr Jason Myers, CEO of ArcherDX, commented: “The three genes in this particular FusionPlex assay can be oncogenic drivers in lung cancer, which makes them great candidates for targeted therapies. The low incidence rates of these mutations make it difficult for laboratories to find renewable sources of controls. By combining HDx Reference Material with the Archer panel, we are able to offer a method to ensure consistency and accuracy.”
About Horizon Discovery
Horizon is a revenue-generating life science company supplying research tools to organizations engaged in genomics research and the development of personalized medicines. Horizon has a diverse and international customer base of over 1,000 organizations across nearly 50 countries, including major pharmaceutical, biotechnology and diagnostic companies as well as leading academic research centers. The Company supplies its products and services into multiple markets, estimated to total in excess of £29 billion by 2015.
Horizon’s core capabilities are built around its proprietary translational genomics platform, a high-precision and flexible suite of gene editing tools able to alter almost any endogenous gene sequence of human or mammalian cell-lines. Horizon offers almost 14,000 products, almost all of which are based on the application of gene editing to generate cell lines that accurately model the disease-causing mutations found in genetically based diseases. These ‘patients-in-a-test-tube’ are being used by customers to identify the effect of individual or compound genetic mutations on drug activity, patient responsiveness, and resistance, which may lead to the successful prediction of which patient sub-groups will respond to currently available and future drug treatments.
In addition, Horizon provides gene editing tools, custom cell line generation services for research and bioproduction applications, quantitative molecular reference standards, in vivo disease models, contract research and custom screening services and custom shRNA development services and off-the-shelf validated shRNA (through Horizon’s partner Sirion).
Horizon is headquartered in Cambridge, UK, and is listed on the London Stock Exchange’s AIM market under the ticker “HZD”.
About Horizon Diagnostics
Horizon is a leading provider of genetically defined, human genomic reference standards, including FFPE cell line sections and purified genomic DNA. HDx™ Reference Standards offer a sustainable source of reference material to laboratories, proficiency schemes and manufacturers, providing an unprecedented level of control.
Variability in DNA extraction from tumour biopsies and a lack of standardisation are currently major sources of error in molecular laboratories. The availability of genetically defined reference materials provides an industry standard for development and quality control of molecular assays, directly improving their accuracy.
Horizon Diagnostics’ suite of reference material includes standards for the increasing number of ‘rare’ mutations being targeted for cancer therapeutics, which by definition are hard to find in clinical samples.
Drawing upon Horizon Discovery’s proprietary genome editing platform, Horizon Diagnostics reconstitutes clinically relevant cancer genes in human cell lines, exactly as they occur in patient tumours. Horizon Diagnostics is able to define virtually every characteristic of its reference standards, from the molecular constitution of the genome to the diameter, width and DNA output associated with each product batch. These standards have been made available in a variety of formats including genomic DNA (gDNA) aliquots, Formalin-Fixed Paraffin-Embedded (FFPE) slices and fluorescent in-situ hybridization (FISH) material. Horizon Diagnostics is also adapting the technology to support immunohistochemistry (IHC) assays.
About ArcherDX, Inc.
ArcherDX, is developing and commercializing a novel approach, Anchored Multiplexed PCR (AMP™), to enrich targets for Next-generation sequencing. AMP™ generates a highly enriched library of gene targets with the advantage of detecting known, or discovering unknown sequence adjacent to sequences of interest. Complemented by proprietary software and readily accessible reports, our technology enables dramatic enhancement in mutation detection speed as well as complex mutation identification and discovery.
The Archer™ NGS Solution
Archer™ NGS utilizes best-in-class fusion detection technology with a lyophilized workflow and an advanced analysis pipeline to comprehensively detect fusions and mutations from as little as 10ng of nucleic acid. Using ArcherDX’s proprietary Anchored Multiplex PCR (AMP™) technology, researchers can detect and identify fusions without prior knowledge of fusion partners or breakpoints.
Archer™ FusionPlex™ assays have been optimized for fusion and mutation detection and characterization, are FFPE compatible, and can run on both Illumina® and Ion Torrent™ next-generation sequencing platforms. Once sequenced, Archer FusionPlex libraries can be analyzed via the Archer™ Analysis Pipeline, a proprietary informatics analysis package that quickly detects and identifies fusion partners of assay genes as well as selected indels and point mutations.
Note: Archer™ kits and analysis software are for research use only and not for use in diagnostic procedures.
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For further information from Horizon Discovery Group plc, please conta
Zyme Communications (Trade and Regional Media)
Katie Odgaard
Tel: +44 (0)7787 502 947
Email: katie.odgaard@zymecommunications.com
Consilium Strategic Communications (Financial Media and Investor Relations)
Amber Bielecka / Jessica Hodgson / Matthew Neal / Laura Thornton
Tel: +44 (0) 20 3709 5701
Email: horizon@consilium-comms.com
Panmure Gordon (UK) Limited (NOMAD)
Corporate Finance: Freddy Crossley / Duncan Monteith / Fred Walsh
Broking: Tom Salvesen
Tel: +44 20 7886 2500
For further information from ArcherDX, Inc., please contact:
Darius Fugere
Tel: 303-571-9000
Email: dfugere@archerdx.com
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