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.