IHC Assay Development

HistoGeneX has developed and validated over 100 assays which have been tested and used in numerous exploratory projects and clinical trials. Our team of board-certified pathologists and deeply experienced scientists and laboratory technologists have developed a proven process for IHC assay development which is embedded into our quality systems.

Additionally HistoGeneX offers chromogenic and fluorescent assay development, for research and clinical trial applications. We also offer multiple analyte detection.

We espouse a full accountability philosophy for our assay development projects. While we select high quality antibody vendors, HistoGeneX has established SOPs that guide us to confirm the quality of the reagents, including detecting variations from reagent lots.

When you approach us for your IHC or IF assay, routine or novel, we use the following proven process to generate the best performing assay.

Gather specific and peripheral information on the assay. 

  • What is the intended use of the assay? 
  • Will the assay be used to detect presence or absence, up- or down-regulation of a target? 
  • Will it be used in an exploratory setting or for patient stratification?
  • Do you already have an antibody selected or available? HistoGeneX has established partnerships with antibody manufacturers for de novo antibody IHC assay development.
  • Do you have control material available? i.e. tissues/cell controls with known expression profiles, preferentially determined with an alternative method.

Initiate assay optimization. HGX strives for a flexible approach in assay development. Depending on your needs, this process can either be completely driven by HistoGeneX or by you.

  • Select your automated staining platform  
  • Establish assay accuracy using predefined control tissues
  • Determine the dynamic window, which is dependent on the intended use of the assay
  • Acquire the best signal to noise ratio

Commence assay validation.

  • Determine precision (intra- and inter-run variability) using standardized image analysis
  • Compare specificity to an alternative method and orthogonal method, if available
  • Analyze performance of the assay (e.g. slide aging, different tissue types) on request

All information will be documented (including images) in a validation report and the final protocol is locked and described in an SOP.