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 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 pathology laboratories. The availability of genetically defined reference standards will provide 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 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 assays.