Abstract
Immunohistochemistry (IHC) is a universally utilized tool for the practice of diagnostic histopathology and is the basis for many clinically essential in vitro diagnostic (IVD) tests. Offering high-value medical and clinical information at a relatively low cost, it provides the singular advantage of allowing the visualization of important biomarkers in the context of the tissue and cellular architecture. In this chapter, we discuss various facets of IVD IHC assay development (such as primary antibody selection and the importance of assay controls) from an industrial research perspective. We then discuss the additional considerations that apply to IHC tests intended for use as complementary or companion IVDs. These concepts are illustrated by discussions of three complementary or companion diagnostic IHC assays in various phases of development at Roche Tissue Diagnostics (i.e., assays for programmed death ligand-1, alkaline lymphoma kinase, and hyaluronic acid). Future possibilities for IHC technology development are briefly discussed.
| Original language | English |
|---|---|
| Title of host publication | Companion and Complementary Diagnostics |
| Subtitle of host publication | From Biomarker Discovery to Clinical Implementation |
| Publisher | Elsevier |
| Pages | 53-91 |
| Number of pages | 39 |
| ISBN (Electronic) | 9780128135396 |
| ISBN (Print) | 9780128135402 |
| DOIs | |
| State | Published - 1 Jan 2019 |
| Externally published | Yes |
Keywords
- Alk (anaplastic lymphoma kinase)
- Biomarkers
- Clinical laboratory diagnoses
- Companion diagnostics
- Hyaluronic acid
- Immunohistochemistry
- Molecular diagnostic techniques
- Pathology
- Pd-l1 (programmed death ligand-1)
- Preanalytical phase