Horizon Discovery Group introduces range of Immunohistochemistry HDx reference standards

Horizon’s diagnostics division provides consistent and reproducible reference standards for IHC assays

The introduction of IHC HDx Reference Standards provides histopathology laboratories with a consistent and reproducible source of reference material for the development and quality control of IHC assays. The independent external controls contain precisely defined protein expression levels presented on one slide, providing scientists the ability to easily determine the sensitivity of their assay. These standards are unique in having undergone a high level of characterization at a molecular and protein level, including Quantitative Digital Pathology (QDP), to quantify the intensity of staining.

Variability in the quality of clinical samples and immunohistochemistry staining is a major concern within pathology laboratories as these techniques are used to confirm diagnoses. Pathologists currently use positive patient tissue material or cultivated cell lines as controls, which are not always available, especially for rare mutations, and can have issues with heterogeneity and consistency. Inaccurate diagnoses can lead to incorrect and ineffective therapies, and so there is a need for solutions that provide higher intra- and inter-laboratory reproducibility of IHC on Formalin-Fixed, Paraffin Embedded (FFPE) tissue sections, in particular the subjective interpretation and scoring of immunohistochemistry assays.

The use of independent external controls enables consistency, reproducibility and accuracy to be maintained and monitored across the laboratory workflow, including operators, assays, manufacturers and platforms. The new IHC HDx Reference Standards from Horizon’s diagnostics division are presented as FFPE cell lines on slides arranged for particular target tumor types. Alongside every positive core there is also a negative protein expressing cell line core to provide an additional level of confidence to laboratories. The range currently consists of biomarkers for clinical relevant mutations: EML4-ALK, ROS1, MET, EGFR and BRAF V600E. The portfolio will be expanded in 2015. These standards are also FISH compatible.

Dr Paul Morrill, President, Products, Horizon, said: “Because all HDx Reference Standards undergo a high level of characterization, we are now able to provide a level of quantitative assessment that is much needed in the field for Immunohistochemistry. The new IHC HDx Reference Standards for the first time offer laboratories a truly consistent, reproducible source of control material for Immunohistochemistry assays.”

For more information about the IHC HDx Reference Standards please visit www.horizondx.com/IHC

 

About Horizon Discovery Group plc

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 over 16,000 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 rAAV, ZFN and CRISPR gene editing tools, custom cell line and in vivo model 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”, for further information please visit: www.horizondiscovery.com


About Horizon Diagnostics

Horizon Diagnostics, a business unit of Horizon Discovery Group plc, 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 standardization 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 HDx Reference Standards 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 tumors. 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, fluorescent in-situ hybridization (FISH) material and immunohistochemistry (IHC) assays.

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For further information from Horizon Discovery Group plc, please contact:

Zyme Communications (Trade and Regional Media)
Katie Odgaard
Tel: +44 (0)7787 502 947
Email: katie.odgaard@zymecommunications.com
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