Horizon Diagnostics (HorizonDx), a division of Horizon Discovery, a leading provider of research tools to support the development and prescription of personalized medicines, announced it has signed a strategic partnership agreement with UK NEQAS. The partnership will focus on the development of genetically defined reference standards for novel lung cancer biomarkers.
HorizonDx is the first company to provide human genomic reference standards containing defined allelic ratios, offering an unprecedented level of control to the diagnostics industry. The reference materials will be used to minimise variability involved in FISH and IHC based diagnostic testing, to guide prescription of targeted cancer therapies.
UK NEQAS ICC (the UK National External Quality Assessment Service) is a leader in diagnostic proficiency assessment. Under the terms of the agreement, UK NEQAS ICC will receive an exclusive license to distribute reference standards related to certain lung cancer biomarkers in the UK and in Europe for the sole purpose of proficiency testing within its quality assessment programme.
Dr Paul Morrill, Commercial Director, Horizon Discovery, commented: “Newly discovered mutations are rapidly shaping how and when novel cancer therapies are prescribed, and quality assurance for diagnostics is a key factor in the prescription of these therapies. Through this partnership with UK NEQAS, we look forward to seeing our genetically defined reference standards adopted in proficiency schemes and as batch controls, ultimately helping to improve the accuracy of diagnostic testing for patients.”
Keith Miller, Director of UK NEQAS ICC, commented “Horizon’s application of its gene editing technology in development of reference standards is ideally suited to diagnostics proficiency testing. We look forward to working with them as the field of cancer therapeutics moves increasingly toward a more personalised approach.”
The partnership is announced following HorizonDx’s launch of a suite of genetically-defined fixed formalin, paraffin embedded (FFPE) cell line standards in September 2011. These cell lines contain defined stoichiometric ratios of, among others, the seven variants of the K-Ras oncogene, for which testing is required to determine individual drug treatment regimens for colorectal cancer patients.
For more information on Horizon’s FFPE standards please visit www.horizondx.com
For more information on UK NEQAS ICC please visit www.ukneqas.org.uk
About Horizon Diagnostics www.horizondx.com
Horizon Diagnostics (HDx), a wholly owned subsidiary of Horizon Discovery Ltd, is the world’s first provider of genetically defined, human genomic reference standards, including FFPE cell line blocks, and purified gDNA. These standards offer a sustainable source of reference material to diagnostic laboratories, proficiency schemes, and manufacturers, and provide an unprecedented level of control to the molecular pathology community.
Variability in DNA extraction from tumour biopsies and a lack of standardisation are currently major sources of error in diagnostic laboratories. The availability of genetically defined controls will provide a gold standard for development and quality control of assays, directly improving analytical accuracy and clinical outcomes.
HDx’ 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 technology, GENESIS, HDx reconstitutes clinically relevant cancer genes in human cell lines, exactly as they occur in a patient’s tumour. This technology approach enables HDx 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. HDx is also adapting its technology to serve immunohistochemistry (IHC) and fluorescent in-situ hybridisation (FISH) based diagnostic tests.
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Contacts:
At Horizon:
Dr Paul Morrill
Commercial Director
Tel: +44 (0)1223 655 580
Email: p.morrill@horizondiscovery.com
Media enquiries:
Katie Odgaard
Zyme Communications
Tel: +44 (0)7787 502 947
Email katie.odgaard@zymecommunications.com