We use the following proven process when you approach us for your ISH-assay, existing or de novo.

Gather Information on the Assay

• What is the intended use of the assay?
• Will the assay be used to detect deletion, amplification, or translocation of a target?
• Will it be used in an exploratory setting or for patient stratification?
• Is the target probe available, either custom manufactured or commercially available? HistoGeneX has established partnerships with probe manufacturers forde novo probe development.
• Do you have control material available? E.g. Tissue/cells with known expression profiles, preferably determined with an alternative gold standard. HistoGeneX works with partners for control material production starting from cell lines.

Initiate Assay Optimization.

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

• The platform choice may depend on the selected probe. HistoGeneX has two (semi-) automated platforms available - the VP2000 (Abbott SA) and Ventana Benchmark XT (Roche).
• Establish assay accuracy using predefined control tissues.
• Determine the best suited pretreatment conditions for the target tissues to obtain the best signals.

Complete Assay Validation

• Determine the precision (intra- and inter-run variability).
• Analyze performance of the assay on request (e.g. slide aging, pre-treatment conditions for rescue-testing, different tumor entities)

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