Integrated Clinical Biomarker Services

From discovery to IND and beyond, we provide a unified approach to biomarker testing and human biospecimen sourcing to accelerate your oncology program.

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Unifying Clinical Research:
Integrated Solutions from Crown Bioscience

Many drug developers face a significant challenge in oncology: the complexity and high cost of managing multiple vendors for clinical-stage programs. Juggling separate partners for biomarker testing, biospecimen sourcing, and data analysis can lead to fragmented data, logistical delays, and increased risk. To address this challenge, Crown Bioscience provides:

Integrated Solutions - We are your single partner for both high-quality Human Biospecimen Solutions and CAP/CLIA-accredited Clinical Biomarker Services.

Seamless Workflow - Our unified approach minimizes vendor management, streamlines communication, and ensures a seamless chain of custody from the patient sample to the final data report.

Actionable Insights - We deliver reliable, integrated data to accelerate your oncology drug development and strengthen your IND submission.

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.

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Why Choose Crown Bioscience for Translational Biomarker Services?

Custom Assay Development

This service is designed around your study goals and sample types—not limited to pre-built panels.

Fast Turnaround and Global Capacity

Agile infrastructure, global logistics support, and multi-site coordination eliminate central lab bottlenecks.

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.

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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.

Service Offerings

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.

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Explore Our Technical Platforms

Crown Bioscience offers 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.

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

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

Download the latest validated markers and panels list

Services Aligned to Your Workflow

Sample Processing and Preparation

We provide services for tissue embedding, sectioning, staining, microdissection, and macrodissection.

Biomarker Identification and Prioritization

Our services include hypothesis-driven and hypothesis-free discovery, as well as predictive and prognostic biomarker analysis.

Pathology and Histology Support

We offer board-certified pathologist review, digital pathology interpretation, and quantification and scoring of biomarkers.

Crown Bioscience Clinical Biomarker Services

Service

Key Features and Capabilities

Integrated Biomarker Testing

Full-service solutions from assay development and validation to data interpretation. Supports drug development across all clinical phases.

Technical Platforms

Tissue Biomarkers: IHC, multiplex immunofluorescence (mIF), spatial transcriptomics, digital pathology, and image analysis.
Genomics and Transcriptomics: NGS, RNA sequencing, and microbiome sequencing.
Proteomics and Immunology: ELISA, multiplex immunoassays, and cytokine profiling.
Bioinformatics: Multiomics data integration, statistical modeling, and interactive data visualization.

Workflow Alignment

Sample Processing: Tissue embedding, sectioning, and staining.
Biomarker Identification: Hypothesis-driven and hypothesis-free discovery.
Pathology Support: Board-certified pathologist review and biomarker scoring.
Data Analysis: Integrated bioinformatics to help interpret complex results.

Compliance and Expertise

Global Lab Network: Access to CAP-, CLIA-, and ISO 15189-accredited labs.
Scientific Team: Direct collaboration with expert scientists from protocol optimization to data delivery.
Accredited Assays: Over 500 prequalified biomarkers, including more than 100 IVD-validated assays.

Frequently Asked Questions

What types of samples do you work with?

We work with a variety of clinical samples including liquid biopsy (cfDNA, ctDNA, CTCs) and tissue biopsy samples.

What is the difference between preclinical and clinical biomarkers?

Preclinical biomarkers are used in laboratory and animal studies to evaluate the safety and efficacy of a drug before human trials. Clinical biomarkers, in contrast, are used in human studies to monitor drug responses, stratify patients, and assess the safety and effectiveness of a treatment.

What types of biomarker services does Crown Bioscience offer?

Crown Bioscience offers a comprehensive suite of clinical biomarker services that span from assay development and sample analysis to data interpretation. Our platforms include:

Tissue-based analysis (IHC, multiplex immunofluorescence, spatial transcriptomics)
Genomics and transcriptomics (NGS, RNA sequencing)
Proteomics and immunology assays
Bioinformatics and data analysis

We also provide support for sample processing, biomarker identification, and pathology.

Are your labs accredited and compliant?

Yes, Crown Bioscience operates a global lab network that includes CAP-, CLIA-, and ISO 15189-accredited facilities to ensure all biomarker testing is conducted in a regulated and compliant environment.

What are clinical biomarkers?

Biomarkers are biological indicators that can be measured to assess normal biological processes, disease states, or a body's response to a therapeutic intervention. In clinical trials, they are essential for monitoring disease progression and a patient's response to a new drug.

Why are biomarkers important for drug development?

Biomarkers play a crucial role in modern drug development by providing measurable insights into how a new therapy works. They can help:

Predict drug efficacy in early research.
Monitor drug response and disease progression during clinical trials.
Identify specific patient populations who are most likely to benefit from a new treatment (a key component of precision medicine).

Using biomarkers can make the drug development process more efficient, potentially reducing costs and accelerating the timeline for new therapies to reach patients.

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.