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Specialty Lab Testing

Advanced specialty science to accelerate your most complex clinical programs.

Every breakthrough therapy demands analytical excellence under pressure.

Biomarker validation programs that must deliver consistent results across global trial sites.

Complex assays designed to withstand regulatory scrutiny. Flow cytometry panels harmonized across continents. And scientific decisions that can’t wait for vendor delays.

Your most ambitious research requires laboratory partners who understand these challenges.

At Cerba Research, we unite deep scientific expertise with cutting-edge technology to support critical decision-making from discovery through commercialization. With 14 specialty laboratories across five continents and the strength of a global central laboratory network, we deliver customized solutions at scale without compromising precision or rigor.

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Histopathology and IHC: Precision pathology for biomarker-driven trials

When tissue-based biomarkers drive clinical decisions.

Modern oncology and immunology trials demand expert pathology interpretation. From PD-L1 expression to multiplex tumor microenvironment analysis, histopathology and IHC provide critical tissue-based insights that guide precision medicine. Our global network of board-certified pathologists and state-of-the-art platforms ensures consistent, reproducible results across your trial sites.

Neutrophil Elastase (Clone SP203) IHC  staining of Larynx Squamous Cell Carcinoma FFPE sample.

Core capabilities:

  • Targets, protocols, and clones for clinical trials:
    • Simplex IHC: ~170 targets
    • Multiplex IHC: ~30 panels
    • Special stains: ~30 types
    • Performed across multiple platforms: Roche Ventana, Dako Omnis, and Akoya PhenoImager.
  • Digital pathology with AI-powered image analysis (Halo®, Visiopharm®, Inform®)
  • International network of board-certified pathologists for centralized review
  • Spatial biology solutions (NanoString® GeoMx, 
FISH, ISH/RNAScope)
  • Fit-for-purpose validation with 3-7-month timelines for regulatory submission depending on validation level

From companion diagnostics to exploratory biomarkers, we provide the histopathology expertise that transforms tissue samples into actionable clinical insights.

Think global, act local

14 specialty laboratories across five continents with advanced technology platforms and therapeutic area expertise

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Europe

North America

Asia-Pacific

South Africa

Specialty Laboratories
Pre-Processing Laboratories
Research & Partner Laboratories

Therapeutic area excellence through scientific depth

Specialized expertise where complexity meets innovation.

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Oncology

  • 360+ trials
  • 80% with specialty testing
  • 32 market authorizations in both solid and liquid tumors
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Infectious diseases and vaccines

  • 460+ trials
  • ~80% of trials include specialty testing
  • BSL3 network
  • 36 market authorizations
  • Expertise in TB, HIV, RSV, COVID-19
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Cell and gene therapy

  • 70+ CGT and hematology-related trials supported globally
  • CAR-T, TCR-T, CAR-NK, AAV, gene editing support
  • 7 market authorizations, including 
3 CAR-T therapies
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Inflammation and immunology

  • 210+ trials
  • ~70% trials include specialty testing
  • Expertise in IBD, osteoarthritis, autoimmune diseases, atopic dermatitis
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Rare diseases

  • ~260 trials
  • Customized biomarker strategies
  • Gene therapy validation
  • 47 market authorizations and expansions
  • Expertise in rare neoplasms, infectious 
or parasitic diseases, skin diseases
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Metabolics and neurology

  • Specialized testing
  • Biomarker discovery
  • Advanced genomics support

State-of-the-art platforms for complex biomarker strategies

From sample to insight: comprehensive specialty testing capabilities.

Cell and gene therapy: Your complete analytical partner

Every cell therapy program faces complex analytical hurdles, from monitoring CAR-T persistence across diverse patient populations to validating vector copy numbers with regulatory confidence.

Cell and gene therapies require highly specialized laboratory expertise at every stage of development. This guide outlines proven analytical strategies that have supported 50+ CGT trials and 5 market authorizations, including 3 CAR-T therapies.

What you’ll discover in our guide:

  • Critical assays for CAR-T monitoring: flow cytometry enumeration, persistence, and phenotyping
  • Strategies for vector copy number, integration site analysis, and biodistribution
  • IVDR-compliant anti-AAV antibody testing for patient selection and monitoring
  • IHC and spatial biology approaches for tumor microenvironment analysis in solid tumor CGT
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Why Cerba Research for specialty laboratory services?

Scientific leadership through early engagement

Our specialist scientists work with you from protocol design to optimize biomarker strategies, develop fit-for-purpose assays, and leverage proven methodologies from hundreds of successful trials. From histopathology validation to complex flow panels, early scientific consultation ensures your testing strategy aligns with regulatory expectations.

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Seamless specialty and central lab integration

When your trial needs both advanced biomarker testing and routine safety monitoring, our integrated platform removes the need for multiple vendors. One partner. One quality system. Seamless data. Our global central laboratory network delivers routine and specialty testing through a single, unified workflow.

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Global scale with therapeutic focus

14 specialty laboratories backed by deep expertise in oncology, infectious diseases, cell & gene therapy, and immunology. Harmonized SOPs and centralized scientific oversight ensure consistent excellence across continents. Our technology breadth, from IHC to NGS to AAV testing, means you never compromise on capability.

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The accreditation and regulatory experience you expect

Our accreditations span continents and therapeutic areas, ensuring your specialty testing meets the highest international standards for regulatory submission across global markets.

CAP
ISO15189
FDA
EMA
CLIA
GLP
IVDR

Ready to advance your biomarker strategy?

Whether you’re developing a companion diagnostic, CAR-T therapy, biologic, or gene therapy, our specialty laboratory services provide the expertise and global infrastructure needed for validated IHC, flow cytometry, immunogenicity, and antibody testing.

Specialty lab testing FAQ