Evotec’s histology solutions empower precision medicine by revealing tissue-level biomarker patterns that predict treatment response. Evotec integrates advanced tissue-based technologies with clinical and drug-development expertise to accelerate biomarker discovery and validation. 

Experience in Histology Solutions at Evotec

We offer 20+ years of expertise in histology assay validation and sample analysis. Every year, we work with:

>80

Histology assay validations

>30

Clients for histology

>1000

Histology samples analysis across studies

>80

Histology assay validations

>30

Clients for histology

>1000

Histology samples analysis across studies

Evotec’s Capabilities in Tailored Histology

Evotec’s histology platform is designed to support biomarker discovery, patient stratification, and decision-making throughout drug development from molecular-to-protein-level analysis. This is complemented by a strong network of key opinion leaders whose expertise informs operational efficiency.

Our capabilities in histology are defined by:

  • Full Spectrum of Techniques: Classical histology, immunohistochemistry (IHC), advanced immunofluorescence (IF), see Figures 1 and 2, and in situ hybridization (ISH), including RNAscope® and BaseScope®
  • Multi-modal Imaging Systems: Bright-field, fluorescence, and confocal microscopy for flexible visualization strategies
  • Automated Analysis for scale: Autostainer (Ventana®, Bond®), whole-slide imaging, and AI-assisted, script-based image analysis
  • Clinical Translational Expertise: In-house veterinary pathology and collaboration with expert clinical histopathologists for translational and clinical programs
Fluorescence microscopy image of brain tissue showing triple immunostaining with three markers: DAPI (cyan) staining cell nuclei, GFAP (yellow) marking astrocytes with their characteristic star-shaped morphology and processes, and IBA1 (magenta) labeling microglial cells. The image shows a dense band of GFAP-positive astrocytes forming a dark curved region across the center, surrounded by DAPI-labeled nuclei in the upper and lower portions. Scale bar indicates 100 micrometers.

Figure 1.  Double-IF of brain microglia (magenta) and astrocytes (yellow) in the mouse hippocampus, with DAPI (blue) counterstain. 

Fluorescence microscopy image of tissue showing triple-channel immunostaining. DAPI (blue) labels cell nuclei throughout the field, CD31 (white) marks blood vessel endothelial cells visible as branching tubular structures, and Target protein (red) shows widespread expression in the tissue with particularly dense staining in the parenchymal regions between vessels. Scale bar indicates 100 micrometers. The image demonstrates the spatial relationship between vascular structures and target protein distribution in the tissue.

Figure 2. Double-IF of human squamous cell carcinoma, where target expression (red) intensifies with increasing distance from CD31-positive tumor blood vessels (white).

What Makes Evotec Different: 

We offer an extensive technique portfolio and multimodal imaging, combined with in-house expertise, to deliver high-quality, custom assay development that supports biomarker discovery and patient characterization

End-to-End Histology Assay Development Workflow

At Evotec, we bring expert consultancy from initial study design through final data delivery to support the development of decision-grade biomarkers (Figure 3). 

  1. Strategic Consultation
    Define study objectives and assess feasibility with input from in-house expertise.
  2. Sample Selection
    Identify optimal histology samples from animal models and patient cohorts, leveraging integration with Evotec's Biomarker and Human Sample Management platforms.
  3. Assay Development 
    Design, optimize, and qualify multiplex histology assays using the full spectrum of techniques, IHC, immunofluorescence (IF) (Figures 1 and 2), ISH (RNAscope®, BaseScope®), with multi-modal imaging (bright-field, fluorescence, confocal microscopy)
  4. Data Delivery
    Execute final testing using automated platforms (Ventana®, Bond® autostainers)whole-slide imaging, and AI-assisted quantification to deliver actionable biomarker insights with statistical validation and clinical context.
  5. Clinical pathologist consultancy
    Clinical pathologists ensure expert validation and guarantee compliance with clinical standards.
Workflow diagram titled "Evotec's Histology Biomarker Workflow" showing five sequential chevron-shaped stages from left to right. Stage 1 (dark blue): "Strategic Consultation" with icon of two people discussing - Define study objectives and assess feasibility. Stage 2 (light blue): "Sample Selection" with person and magnifying glass icon - Identify optimal histology samples from animal models and patient cohorts. Stage 3 (light blue): "Assay Development" with computer and laboratory equipment icon - Design, optimize, and qualify multiplex histology assays. Stage 4 (very light blue): "Data Delivery" with computer and chart icon - Execute final testing using automated platforms and AI-assisted quantification. Stage 5 (pale pink): "Clinical Pathologist Consultancy" with document and checkmark icon - Ensure expert validation and compliance with clinical standards.

Figure 3. Evotec’s end-to-end histology assay development workflow.

Multi-modal Analysis to Identify Cancer Responsiveness

Evotec’s histology platform has demonstrated how advanced histology platforms support patient characterization and the identification of the cancer subtype most responsive to treatment.

Aim: Identify the tumor subtype most likely to respond to treatments based on the hypothesis that high biomarker expression correlates with therapeutic efficacy. 

Method:multi-modal analysis, integrating IHC data, was conducted and correlated with clinical outcomes to pinpoint the cancer type most responsive. See Figure 4.

Outcome: Patients were stratified by target expression, and those with a high percentage of target area coverage were identified as the cancer type best suited for a Phase 1 proof-of-concept study.

Evotec biomarker histology case study: Research data presentation showing histopathology evaluation across two clinical indications (n=50 each). Top section displays representative immunohistochemistry images for Indication 1 and Indication 2, both showing brown-stained tissue samples. Bottom section contains a stacked bar chart titled "H-score component per patient for one indication (25 patients)" with y-axis showing "Percentage of target area covered by target per patient" (0-100%). Each bar represents one patient and is color-coded to show staining intensity: white for weak, gray for moderate, and black for strong expression levels. The data demonstrates heterogeneous expression patterns across the patient population.

Figure 4. Representative labeling of the target in two oncologic indications. Quantification via H-score was performed and validated by an independent clinical histopathologist. Patient stratification based on target expression and associated clinical data was confirmed in both indications, supporting indication prioritization for translational development.

TODO

Histology Platform for Oncology

Explore our factsheet to learn more.

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Accelerate Biomarker Translation with Evotec's Histology Expertise

Evotec's histology platform bridges the gap between tissue analysis and clinical decisions. Our integrated approach delivers the biomarker insights needed to stratify patients, prioritize indications, and advance precision medicine programs.

With 20+ years of expertisein-house pathology specialists, and seamless integration with sample management platforms, we transform tissue samples into actionable data that drives decisions.

Ready to discuss your histology biomarker needs? Our biomarkers team is here to help.

Frequently Asked Questions

Which tissue types and sample formats are supported?

We work with a wide variety of tissue types and sample formats, including tumor resections, biopsies, and tissue microarrays (TMAs), as well as healthy tissues from various species, such as mice, non-human primates (NHPs), humans, and others.

Can histology assays be transitioned into clinical trial settings?

Yes, histology services can be validated for exploratory biomarker analysis under non-Good Clinical Practice (GCPconditions, following a GCP-like framework to guarantee scientific rigor and traceability.

Is histology data integrable with other modalities?

Yes, we can integrate our histology data with other modalities like genomics, transcriptomics, proteomics, imaging, and clinical data.

Is access to patient samples integrated for histology?

Yes, histology at Evotec is closely integrated with the Biomarker and Human Sample Management platforms, enabling us to efficiently identify the most relevant patient samples.

Elizabeth van der Kam

Elizabeth van der Kam

SVP Global Translational Biomarkers

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Evotec has the right technologies & disease understanding to meet our partners' evolving needs: a comprehensive disease knowledge at the molecular level, cutting-edge technologies & platforms to translate this expertise into effective precision medicines.