Histopathology Service

Histopathological examination is a critical component of preclinical research, serving to determine the efficacy, safety, and mechanism of action (MOA) of candidate anticancer drugs or therapeutics. Alfa Cytology provides comprehensive histopathology services, encompassing paraffin/frozen/tissue microarray (TMA) sectioning, routine and specialized embedding, pathological staining, immunofluorescence, immunohistochemistry, confocal microscopy, and fluorescence microscopy, to support your oncology drug development programs.

Introduction to Histopathology

Histopathology serves as a critical bridge connecting molecular events with whole-animal efficacy, providing spatial information in oncology drug development that cannot be obtained from molecular lysates or liquid biopsies. Routine pathological techniques such as H&E staining clearly delineate the distribution of tumor cells and stroma, vascular density, necrotic areas, and the extent of inflammatory infiltration, establishing the histological context for subsequent molecular localization studies. Immunohistochemistry and immunofluorescence, while preserving tissue spatial architecture, precisely localize the expression and intensity of target proteins, offering critical evidence for target selection and biomarker strategies. In pharmacodynamic evaluation, quantitative analysis of proliferation marker (Ki-67) downregulation, apoptosis marker (cleaved caspase-3) upregulation, and changes in target protein phosphorylation levels following drug administration provides direct confirmation of biological activity, supporting dose selection and combination strategy optimization. Furthermore, multiplex immunofluorescence enables simultaneous characterization of multiple immune components, including CD8⁺ T cells, FoxP3⁺ regulatory T cells, CD68⁺ macrophages, and PD-L1⁺ cells, with quantitative analysis of their abundance and spatial distribution, providing direct histological evidence for the design of immuno-oncology combination strategies.

Fig. 1 Workflow of the proposed approach for predicting patient sensitivities to different drugs from histology images. (Dawood M, et al.; 2024)

Our Services

Alfa Cytology offers a comprehensive suite of histopathology services designed to support cancer research and preclinical drug development, from target validation and pharmacodynamic assessment to tumor microenvironment profiling and combination strategy optimization.

Our histopathology platform integrates paraffin/frozen/TMA sectioning, routine and specialized embedding, pathological staining, immunohistochemistry, immunofluorescence, confocal microscopy, and fluorescence imaging to deliver high-quality spatial biology data. Whether you are validating target protein expression, assessing drug efficacy in tumor models, or investigating immune cell infiltration patterns, our specialized oncology pathology team is equipped to address your specific research needs.

Test Types

Supported Therapeutic Modalities

Our pathology services are designed to support the development of diverse therapeutic modalities. Ranging from target engagement validation and pharmacodynamic biomarker evaluation to comprehensive immune microenvironment profiling, our integrated pathology platforms deliver essential histopathological evidence to accelerate your oncology drug discovery and development initiatives.

Small Molecule	Therapeutic Antibody	Cell Therapy	Gene Therapy
Cancer Vaccine	Peptide Therapy	Nucleic Acid Therapeutics	Oncolytic Viral Therapy

Applicable Samples

Our histopathology services accommodate a wide range of sample types, supporting comprehensive analysis from preclinical models to clinical specimens:

• Preclinical model tissues: CDX/PDX tumor tissues, genetically engineered mouse (GEMM) tumor tissues, normal organs and tissues (heart, liver, spleen, lung, kidney, brain, etc.), xenograft tissues.
• Clinical specimens: Surgically resected tumor tissues, biopsy tissues (core needle biopsy, fine needle aspiration), FFPE tissue blocks, tissue microarrays (TMA).
• Specialized samples: Bone and calcified tissues, tissues with implants, vascular/neural tissues, embryonic tissues.

Applications of Our Histopathology Service

Our histopathology platform is broadly applicable across the following research areas, delivering critical tissue-based evidence to support your target discovery, pharmacodynamic evaluation, and translational research.

Target Discovery and Validation

Enables in situ target validation via IHC/IF, providing evidence of protein expression specificity, tissue distribution, and subcellular localization to support target prioritization.

Pharmacodynamic Evaluation

Delivers quantitative endpoints (Ki-67, cleaved caspase-3, CD31) to assess drug efficacy, supporting dose selection, regimen optimization, and go/no-go decisions.

Preclinical Safety Assessment

Provides histological evaluation of major organs to assess off-target toxicity, delivering essential data for IND-enabling toxicology studies.

Biomarker Development

Facilitates biomarker screening and validation using tissue microarrays and multiplex IHC/IF to support patient stratification and companion diagnostic development.

Translational Research

Enables direct comparison of histopathological features between preclinical models and clinical specimens to assess disease relevance and improve clinical translation.

Resistance Mechanism Studies

Characterizes histological, protein, and immune microenvironment changes before and after resistance development to uncover resistance mechanisms and guide combination strategies.