ICON creates custom IHC assay development and validation strategies
Our immunohistochemistry (IHC) offering shares the same foundation that underlies our nucleic acid assay products – scientific rigor, technical excellence and adherence to design control principles that ensure the timely delivery of accurate, reliable and actionable data.
Based on the needs of a programme, we can customise an IHC assay development and validation strategy to enable retrospective or prospective analysis of clinical trial specimens, all performed in our CAP-accredited CLIA laboratory. Our regulatory and manufacturing capabilities can support an IHC-based test from implementation in a Phase I clinical trial to PMA submission for an IVD-grade medical device.
Ventana Benchmark ULTRA, Leica Bond III and Dako Omnis and Link 48 automated IHC platforms are available for performing assay optimisation and running IVD assays. Our digital pathology capabilities include whole-slide digital scanning (Aperio and Ventana platforms), image annotation and web-based virtual slide review with a board-certified pathologist.
- Paraffin Dip
- H&E Staining
- FFPE Block Tissue Sectioning
- Tissue Processing & Embedding
- Pathology Review - H&E and stained slides, H-scoring
- CD3,CD8, CD20, CD34, CD138, CD163
- MAGE-A, MHC Class II
- DAKO 22C3 PD-L1