Redefining Reference Standards

What is the impact of molecular assay failure in your laboratory?
Identify and eradicate the source of erroneous results in your laboratory

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 tumor 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 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 platform, GENESIS™, 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 and fluorescent in-situ hybridization (FISH) material.  Horizon Diagnostics is also adapting the technology to support immunohistochemistry (IHC) assays.

HDx™ Reference Standards are already having a profound impact on the molecular labs that have adopted them:

  • Validate the sensitivity and Limit of Detection (LOD) of  molecular assays
  • Routinely calibrate the sensitivity of assays in order to maintain quality control
  • Control pre-analytical processes, including DNA extraction and quantitation using in-process standards
  • Compare assay performance between platforms, assays and users from a common reference point
  • Support raising standards through providing materials for staff training and proficiency schemes

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