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Quantitative Reference Standards That Provide Quality and Consistency Are Now Available (Read more)

Horizon to provide genetically defined human genomic reference standards for cancer diagnostics proficiency testing schemes

Cambridge, UK, March 26 2012: Horizon Diagnostics (HDx), a division of Horizon Discovery Limited, a leading provider of research tools to support the development and prescription of personalized medicines, today announced it has signed a strategic partnership agreement with the European Molecular Genetics Quality Network (EMQN). Under the terms of the agreement, HDx will provide genetically defined human cell line reference standards for distribution to molecular diagnostic laboratories around the world as part of EMQN’s annual External Quality Assessment (EQA) schemes to ensure sensitivity and reproducibility of diagnostic assays. 

The reference materials provided by Horizon will contain known frequencies of mutations that currently guide the prescription of cancer therapies, and particularly melanoma, colon and lung cancers. The reference materials will be distributed to participants in EMQN’s proficiency testing schemes which will be assessed for their ability to accurately test the samples and provide a clear and concise test report on the results.

Diagnostic EQA providers face significant difficulties in sourcing reliable reference materials for diagnostics testing, either from patient samples or immortalized cell lines, especially as increasing numbers of rare mutations are being discovered. Horizon’s reference standards overcome this by reconstituting mutations of interest in human cell lines using its proprietary genome editing technology, GENESIS™, and creating a defined wild type parental to mutant ratio in each sample.

Dr Paul Morrill, Commercial Director, Horizon Discovery, commented: “Quality assurance schemes such as those organized by EMQN are essential to ensure that patients receive the correct treatment regimen based on their tumor mutation status. Horizon’s technology offers pathologists and biologists an unprecedented level of control, and a resource for benchmarking the performance of assays against validated empirical reference standards. This is an invaluable component of patient care”

Dr Simon Patton, Director of EMQN, said: “The availability of Horizon’s defined reference standards enables vastly improved proficiency testing across the diagnostics industry. We look forward to working with Horizon on developing standards for the increasing number of clinically relevant mutations that are supported through our EQA schemes.”

For more information on EMQN please visit www.emqn.org

Online Ordering Website Launched

Cambridge, UK, February 24 2012: Horizon Diagnostics (HDx), a division of Horizon Discovery Ltd, a leading provider of research tools to support the development of personalized medicines, has launched an online ordering website (www.horizondx.com) for its initial offering of 31 genetically defined human genomic reference standards, including FFPE cell line blocks, and purified genomic DNA. HDx reference 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.

UCL Advanced Diagnostics (UCLAD), specialists in molecular, ISH and FISH testing in the UK, will also be hosting a section dedicated to HDx reference standards on its new website, and will be endorsing the products.  This relationship emphasizes the increasing adoption and support of HDx reference materials by the industry.

The website will be the foundation for providing Horizon’s off-the-shelf reagents to its customers. Sales generated from these reagents will provide a steady source of income and will support the Company’s larger Business to Business deals.

The site will also provide a valuable source of data through the customer review facility, which will be converted by Horizon into application notes to enable all customers to benefit.

The new online ordering site allows customers to order reference standards easily and quickly, with delivery within 5 working days and often as quick as next day delivery.

Horizon Diagnostics and UK NEQAS ICC Announce Partnership

Cambridge, UK, January 31 2011: Horizon Diagnostics (HorizonDx), a division of Horizon Discovery, a leading provider of research tools to support the development and prescription of personalized medicines, today 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 fluorescence in situ hybridization (FISH) and immunohistochemistry (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 UK NEQAS please visit www.ukneqas.org.uk