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Global Specialty
Biomarker Laboratory

for Translational Research
and Clinical Trials

Integrated biomarker testing to accelerate
drug development across clinical phases
and therapeutic areas.

Our CAP-, CLIA-, ISO 15189–accredited, and clinical-compliant labs in North America, APAC, and Europe deliver high-quality data with speed and flexibility.

Contact Us Capabilities Sheet Regulatory Information

Crown Bioscience is a global specialty biomarker laboratory supporting drug development across all clinical phases and therapeutic areas.

We deliver integrated biomarker testing services—from assay development and sample analysis to data interpretation—anchored in scientific expertise and global compliance. Our platforms span tissue-based methods, spatial and multiomics technologies, advanced flow cytometry, and bioinformatics—empowering faster, more confident translational decisions.

Why Choose Crown Bioscience for Translational Biomarker Services?

Custom Assay Development

Designed around your study goals and sample types—not limited to pre-built panels

Fast Turnaround and Global Capacity

Avoid central lab bottlenecks with agile infrastructure, global logistics support, and multi-site coordination

Responsive Scientific Engagement

Work directly with expert scientists—from protocol optimization to data interpretation

Compliant Global Lab Network

Access biomarker testing in RUO or regulated environments, including CAP-, CLIA-, ISO 15189–accredited, and clinical-compliant labs

Deep Translational Expertise

Access domain knowledge in tumor biology, immunology, and high-dimensional data analysis

Integrated Biomarker Strategy

Accelerate insights while maintaining compliance—from RUO exploration to trial-readiness

Clarity from Complexity

How Our Bioinformatics Team Helps You Succeed

Unlock insights from your most complex datasets—with confidence. Our 20+ member bioinformatics team brings over 13 years of experience supporting oncology and immunology programs across preclinical and clinical stages. Whether you're identifying predictive biomarkers, stratifying patient populations, or interpreting multiomics and spatial data, we help you turn complexity into clarity—faster.

What We Support

Crown Bioscience provides end-to-end biomarker testing solutions, from biomarker discovery to clinical validation:

  • Exploratory biomarker research (RUO use)
  • Proof-of-concept and mechanism-of-action studies
  • Predictive, pharmacodynamic, and prognostic biomarker analysis
  • Panel design and marker selection consulting, especially in mIF, spatial, and flow cytometry settings
  • Assay development, optimization, and validation for translational and clinical studies
  • Method transfer and feasibility testing
  • Fit-for-purpose assay qualification for early clinical trials
  • Clinical trial support: Phase I–II
  • Human sample testing under CAP, ISO 15189, CLIA or clinical-compliant (where applicable)

Crown Bioscience is committed to delivering high-quality, compliant biomarker data that meets the needs of translational research and clinical development, regardless of your location.

Explore Our Technical Platforms

We offer a broad range of validated technology platforms to meet the diverse needs of translational and clinical biomarker testing. Click below to explore our capabilities by technology domain:

Capabilities by Technology Domain

Tissue Biomarker Analysis

 
  • Immunohistochemistry (IHC) and multiplex IHC

  • Multiplex immunofluorescence (mIF): PhenoImager® (Akoya Biosciences), InSituPlex® (Ultivue)

  • In situ hybridization: Fluorescence in situ hybridization (FISH), RNAscope® ISH (Advanced Cell Diagnostics)

  • Digital pathology and AI-powered image analysis: HALO® AI (Indica Labs), Oncotopix® (Visiopharm), in-house bioinformatics pipelines, board-certified pathologist review

  • Spatial transcriptomics and proteomics: GeoMx® DSP (Digital Spatial Profiler, NanoString Technologies), Visium Spatial Gene Expression v1, v2, and HD (10x Genomics)

  • Tumor tissue microarrays (off-shelf and custom available upon request)

  • Rare cell analysis

  • High-content imaging

Genomics and Transcriptomics

 
  • Targeted NGS panels (e.g., CAP-accredited NGSST, TSO500)

  • Gene expression profiling panel: nCounter® (NanoString Technologies)

  • Whole exome sequencing (WES) and whole genome sequencing (WGS)

  • RNA sequencing (RNA-Seq), long non-coding RNA sequencing (lncRNA-Seq)

  • Single-cell RNA sequencing (10x Genomics Chromium)

  • Whole genome bisulfite sequencing (WGBS)

  • Microbiome sequencing: full-length 16S rRNA, metagenomics

  • PCR, qPCR, digital droplet PCR (ddPCR), Sanger sequencing

  • Long-read sequencing (PacBio)

  • Optical genome mapping (Bionano Genomics)

Proteomics and Protein Analysis

 
  • Flow cytometry for protein markers: traditional and spectral

  • Immunoassays: ELISA, MSD, Luminex®, ELISpot

  • DIA mass spectrometry: global, targeted, and post-translational modification (PTM) proteomics

  • Western blotting: standard and Simple Western™

  • 2D gel electrophoresis

Immunology Assays

 
  • Flow cytometry and fluorescence-activated cell sorting (FACS): traditional and spectral

  • T-cell functional assays

  • Cytokine and chemokine profiling (MSD, Luminex®)

  • Immune cell phenotyping

Bioanalysis and Biofluid Testing

 
  • Bioanalytical assays for small molecules, biologics and ADC
  • Ligand binding assays
  • Biomarker analysis in plasma, serum, and urine
  • Complete blood count (CBC), blood chemistry, and general biochemistry

Capabilities by Sample Type

Liquid Biopsy

 

cfDNA, cfRNA, ctDNA, CTCs, EVs, plasma proteomics, clinical chemistry

Tissue Biopsy

 

histology, IHC/mIF, spatial omics, NGS/proteomics, digital pathology

Other Biofluids

 

urine, CSF, BAL, and others

 
 

What We Deliver: Services Aligned to Your Workflow

Sample Processing & Preparation

  • Tissue embedding, sectioning, staining, microdissection and macrodissection

Biomarker Identification & Prioritization

  • Hypothesis-driven and hypothesis-free discovery
  • Predictive and prognostic biomarker analysis

Pathology & Histology Support

  • Board-certified pathologist review
  • Digital pathology interpretation
  • Quantification and scoring of biomarkers

Bioinformatics & Data Analysis

  • Multiomics data integration
  • Statistical and computational modeling
  • Interactive visualization and reporting

Capability Spotlight: IHC and mIF Services

With over 500 prequalified biomarkers—including 100+ IVD-validated assays—our IHC and multiplex immunofluorescence (mIF) services are designed to support both exploratory research and clinical trial readiness. Selected assays are CAP-accredited and interpreted by board-certified pathologists. With advanced image analysis powered by AI and proprietary software, whether you're assessing pharmacodynamic endpoints or generating tissue-based biomarkers for regulatory submission, we deliver reliable, publication-quality data with speed and precision.

Select CAP-accredited IHC markers include:

  • Ki-67
  • ER / PgR / Her2 / gastric Her2
  • HER2 dual ISH
  • PD-L1
  • MLH1 / MSH2 / MSH6 / PMS2
  • CD20

Our panel is continually expanding. Contact us for the latest validated marker list.

Download validated markers and panels list

~500 Pre-qualified Human Markers and Pre-qualified Panel List for IHC, IF and RNAscope ISH

Partner with Crown Bioscience for Your Translational Clinical Biomarker Needs

Ready to accelerate your oncology research with high-quality clinical biomarker services? We are your trusted partner, providing meticulously characterized samples essential for drug discovery, biomarker validation, and precision oncology studies.

Contact Us

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