Horizon Discovery Group plc (LSE:HZD) (Horizon), the international life science company supplying research tools and services that power genomics research and the development of personalized medicines, today announced it has introduced a unique range of genetically defined, highly characterized HDx Reference Standards for Immunohistochemistry (IHC) assays. The product range has been developed by Horizon’s diagnostics division.
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.”