Invicro’s Advanced Pathology Services (APS) team provides end-to-end solutions to support translational and clinical research by providing a combination of routine and unique tissue testing services. As part of the REALM IDx, Inc. group, our pathology service laboratories support projects spanning preclinical biomarker discovery research to clinical trials and development of companion diagnostics (CDx) products. Our scientific, operational and regulatory expertise enables us to deliver insights needed to take lead drug candidates to the next level.

As an early-phase and clinical service provider, we offer routine and novel pathology services, including core histology, specialty stains, multiplex Immunohistochemistry (IHC), multiplex immunofluorescence (IF), Advanced Cell Diagnostics (ACD) RNAScope®,  BaseScope™ and miRNAScope™ ISH with the option to perform select assays in a CAP-accredited, CLIA-certified laboratory. With laboratory locations in Boston, MA, Irvine, CA, and Japan, we are able to support projects spanning all phases of drug discovery and development.

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Invicro’s Advanced Pathology Services multidisciplinary team provides end-to-end discovery, translational research and clinical trial pathology services for pharmaceutical and biotechnology partners. We support studies across many therapeutic areas,  including oncology, immuno-oncology, neurology, immunology and systemic diseases. Our unparalleled scientific expertise coupled with our operational capabilities allows us to support a variety of project types.

For all projects processed in our laboratory, our dedicated scientific and project management teams collaborate closely with sponsors to design studies that will deliver the insights needed to support research efforts at all stages of discovery and development. When partnering with Invicro, we ensure both sides are aligned on expectations and provide the highest level of transparency expected from a contract research partner.


Discovery Research

  • Receptor binding assays
  • Image analysis

Translational & Clinical Research 

  • Assay design, development and validation
  • Routine & specialty stains
  • Immunohistochemistry (IHC) / Immunofluorescence (IF)
  • RNAScope®, BaseScope™ and miRNAScope™ ISH
  • Whole Slide Imaging (WSI)
  • Image analysis and reporting
  • Pathologist consultation and immunostaining interpretation
  • Non-GLP Tissue Cross-Reactivity (TCR) assays
  • 510(k) tissue-based submission tests for medical devices
  • Regulatory filing support
  • Companion Diagnostic (CDx) development for IHC and RNAScope® ISH
  • Quanticell™ High sensitivity IHC

Download our translational tissue biomarker services flyer here!

Spatial Biology

Explore Biomarker Discovery with Spatial Resolution

Spatial biology is a powerful approach to study tissue architecture and the cell microenvironment for advanced insights into disease pathogenesis. With spatial transcriptomics and spatial proteomics, investigate cell types, localization, interactions and biomarker expression patterns within a tissue sample.

In addition to traditional multiplexed immunofluorescence and immunohistochemistry solutions, Invicro currently offers Akoya Biosciences and Ultivue spatial proteomics solutions.

Spatial Proteomics


Akoya Biosciences

Invicro is a qualified CRO service provider of Akoya Biosciences® spatial proteomic solutions. Akoya’s technology analyzes intracellular and extracellular proteins on formalin-fixed, paraffin-embedded (FFPE) tissue sections, enabling protein-based single-cell analysis of tissue architecture. Fresh frozen tissue section solutions are also available.

Invicro is the only qualified CRO service provider to offer both the Phenocycler®-Fusion System for high-plex assays and the PhenoImager® HT for high volume experiments.




PhenoCycler®-Fusion System


Provides a comprehensive solution for spatially-resolved, highly multiplexed (up to 100+) biomarker analysis on a single slide.  Both preconfigured and customizable panel options are available.
View Panel Offerings

PhenoImager® HT

PhenoCode™ Signature Panels:

Enables multiplexed analysis of up to 6 checkpoint or immune cell biomarkers with flexible panel reconfiguration.

Opal Panels™:

Analyzes up to 8 fully customizable tissue biomarkers plus nuclear counterstain in a single image.


Invicro is developing a custom spatial biology image analysis pipeline using many of Invicro’s internal capabilities including VisioPharm®, R Studio, and Akoya’s inForm® for visualizing and quantifying biomarkers in tissue sections. Typical outputs will include cell phenotypes, cellular neighborhoods and clustering maps.

We partner with each client to generate data insights geared to specific research initiatives. All images are shared via through our secure File Transfer Protocol (FTP) service and are fully compatible with open-source viewers such as QuPath or free viewers such as OlyVIA from Olympus.



Invicro is a proud provider of Ultivue assays which offer spatial proteomic insights for profiling cancer biology. Ultivue’s proprietary InSituPlex® technology analyzes intracellular and extracellular proteins, is compatible with FFPE sections, and enables multiplexed insights into the tumor microenvironment. We offer the following Ultivue assays:




Choose from pre-configured 4-plex or 8-plex panels to identify specific cells in the tissue microenvironment.


Customize your immune profiling assay by starting with the Immuno8 FixVUE panel and switching out up to 2 biomarkers for an 8-plex panel. Invicro works closely with Ultivue to develop these assays.


Fully customized panel utilizing pre-optimized menu and non-menu biomarkers. Invicro works closely with Ultivue to develop these assays.


Invicro utilizes Visiopharm® and custom scripts to produce cell segmentation and cell phenotyping outputs to provide data insights for each client’s research questions. All spatial biology images are shared through our secure FTP service and are fully compatible with open-source viewers such as QuPath or free viewers such as OlyVIA from Olympus.


Spatial Transcriptomics


10x Genomics – Coming April 2023

Invicro is expanding our spatial biology capabilities with the upcoming service launch of Visium Spatial Gene Expression from 10X Genomics. Explore cell types, states and biomarkers in a morphological context with the ability to map total single-cell RNA sequencing data to the tissue microenvironment in both FFPE and fresh frozen tissue.

Immunohistochemistry (IHC)

Immunohistochemistry (IHC) is a powerful tissue-based method used both in research and clinical diagnostics to evaluate pathological conditions. IHC allows for the visualization of target antigens on the cellular and subcellular level with tissue morphology preserved in a wide-range of sample types, such as solid tumor biopsies, lymph nodes and other isolated tissues. In clinical practice and drug development, IHC is widely used as a companion diagnostic test to stratify patients and monitor the efficacy of therapeutic treatments. With rapid advancements made in the field of immunotherapy, IHC remains a valuable assay to support the development and approval of cutting-edge therapies.

Our laboratories possess the scientific, regulatory and operational expertise to develop and run immunohistochemistry (IHC) assays across multiple therapeutic areas. From early-stage discovery to exploratory endpoint testing and CDx development, our team is prepared to support all your project needs to expedite drug discovery and development efforts. We perform IHC on xenograft tumor models, tissue microarrays (TMA), and a diverse population of human and non-human tissue samples. It is our mission to provide biomarker insights needed to help you make smart decisions that will accelerate drug development efforts.

With multiple laboratory locations and CAP-accredited CLIA-certified sites, we offer comprehensive IHC services to support projects with varying levels of complexity. Our laboratories are equipped with the latest research and clinical tissue processing equipment from Leica, Agilent Dako, Biocare Medical and Ventana to support your specific project needs.


Core Service Capabilities

  • Scientific consultation
  • Tissue processing & embedding
  • FFPE/fresh frozen serial sectioning
  • Custom assay development
  • CAP/CLIA assay validation
  • Singleplex, multiplex IHC
  • Multiplex IHC combined with RNAScope® ISH
  • Whole slide imaging (WSI)
  • Pathologist interpretation
  • Non-GLP Tissue Cross-Reactivity (TCR) assays
  • 510(k) tissue-based submission tests for medical devices


Multiplex Immunostain Examples

Immunofluorescence (IF)

Immunofluorescence (IF) is a powerful approach to detect and visualize multiple (e.g., 4-plex, 8-plex) biomarkers while preserving tissue morphology to understand spatial relationships. Multiplex Immunofluorescence is an effective approach to examine the colocalization of infiltrating immune cells within the tissue microenvironment, which is particularly important in immuno-oncology drug development.

Developing multiplex immunofluorescent assays and analyzing the data is a challenging process that requires domain knowledge and expertise. Invicro’s team of scientific experts provide a consultative approach to study design, execution, analysis, and reporting. Our approach starts with understanding the question that needs to be answered followed by designing a study that will deliver new insights required to support translational research. We are a platform agnostic solutions provider and can develop new assays using a wide-range of staining chemistries, including tyramide signal amplification (TSA)-based Akoya Opal sequential staining, DNA barcoding-based Ultivue InSituPlex, Ventana multiplex panels, and others. All staining workflows can be developed on automated platforms, including the Leica Biosystems BOND RX or the Ventana DISCOVRY ULTRA.

Core Service Capabilities 

  • Scientific consultation
  • Study design
  • Tissue processing & embedding
  • FFPE serial sectioning
  • Antibody optimization (e.g., monoplex chromogenic/fluorescent optimization)
  • Assay detection optimization
  • Multiplex IF combined with RNAScope® ISH
  • Multispectral imaging
  • Image analysis
  • Reporting

Digital Pathology & Image Analysis

Invicro’s dedicated image analysis team provide end-to-end digital pathology capabilities to support all drug research and development phases from biomarker discovery to clinical trials. By partnering with us, we provide research services with rapid turnaround times (TATs) to help uncover biological insights to advance your scientific research. We deploy state-of-the-art analysis workflows to identify phenotypes within the tissue context. In addition to providing combined tissue processing and analysis, we accept digitized slides for analysis only projects to provide clients access to tailored project solutions. To digitize slides for analysis applications, our laboratories are equipped with a broad portfolio of commercial, state-of-the-art systems and image analysis tools.

By combing cutting-edge technologies and software, including Visiopharm and other in-house custom developed tools to meet your specific needs, with our deep expertise in data analytics, we deliver solutions that support brightfield and multispectral fluorescent imaging techniques used to detect biomarkers and phenotype immune cells in the tumor microenvironment (TME). We help clients solve complex research studies by offering analysis solutions for all testing methods, including core histology, multiplex IHC/IF and Quanticell–Konica Minolta’s proprietary high sensitivity, quantitative IHC assay.

Core Analysis Services

  • Tumor scoring
  • Immune cell counting
  • Multiplex stain quantification
  • RNAScope® BaseScope™ and miRNA™ ISH analysis
  • Multiplex IHC combined with ISH to visualize gene and protein targets
  • Morphological analysis
  • Custom application development/transfer


Core Histology & Specialty Stains

In addition to our routine immunohistochemistry and novel quantitative biomarker imaging solutions, Invicro provides multiple specialty stains to support your research efforts across multiple disease areas.    


Alcian Blue-PAS-hematoxylin stain Alkaline Phosphatase stain
Aniline Blue stain Bielschowsky’s silver stain
Goldners Trichrome stain Gomori’s Trichrome stain
Gram stain H&E
Luxol fast blue and PAS stain Masson’s Trichrome stain
Methylene blue/basic fuchsin stain Movat pentachrome stain
Nissl stain PAS
Jones stain (PAM) Picrosirius red/van gieson picrofuchsins stain
Safranin O/fast green stain Sirius red stain
Toluidine blue Stain TRAP stain
TUNEL stain Von kossa stain

Clinical Trial Services

In addition to our translational biomarker services, Invicro provides clinical pathology services to support clinical trial and companion diagnostic (CDx) development programs. Our CAP-accredited and CLIA-certified laboratory possess the operational experience to optimize and validate biomarker assays, including CAP-CLIA validations and analytical validations needed for FDA submissions. We have established processes to ensure our laboratory remains fully compliant with all regulatory requirements for clinical studies.

Sample Acquisition

  • Inspect sample quality and accession into LIMS system for sample chain of custody

Sample Preparation

  • Fix, process, section FFPE or fresh frozen tissues

Custom Assay Development / Assay Transfer

  • Source and optimize commercially available or sponsor’s proprietary antibodies, identify control tissues and/or cell lines, identify isotype controls, optimize antigen retrieval conditions, select commercial staining platform

Stain Tissue Sections

  • Stain primary tissues/tissue microarrays (TMA) using pre-optimized assay conditions and controls

Whole Slide Imaging (WSI)

  • Scan slides at 20X or 40X to digitize slide (generate svs files) for image transfer or image analysis

Interpretation and Scoring

  • Board-certified pathologist (MD) review, including qualitative review, establishing cutoffs, and IHC scoring

Image Analysis

  • Segmentation, morphological assessment, cell counting, distribution analysis, multiplex stain analysis using in-house tools and of the shelf software, including Visiopharm and other custom developed tools


  • Deliver final report to sponsor, including methodologies utilized, complete analytical study results, statistical analyses

Data Management

  • Collate pathology image data using iPACS®–Invicro’s flagship data management platform to streamline data accessibility

Quanticell™ High Sensitivity Immunohistochemistry (IHC)

Quanticell is advanced and highly sensitive immunohistochemistry-based technology that accurately detects and quantitates specific target antigens at the molecular level supporting drug discovery and development. This quantitative immunohistochemistry assay uses novel fluorescent phosphor-integrated dots (PIDs) and provides superior sensitivity and uniformity compared to conventional immunofluorescent imaging and immunohistochemical methods. PIDs are organic fluorophore assembly-conjugated nanoparticles with unique properties including: uniform size, high intensity fluorescent signal, high photostability (densely packed fluorophores networked via chemical binding), high sensitivity, and broad dynamic range. At Invicro, our image analysis team uses the latest artificial Intelligence-based capabilities to analyze tissues stained with this innovative technology.

To overcome specific detection-related challenges, this assay offers higher sensitivity compared to common chromogenic and fluorescent-based detection methods. This service enables sponsors to:

  • Visualize and quantitate low expressing targets and immune cells
  • Evaluate and measure drug distribution alongside the drug target
  • Monitor and quantify drug pharmacodynamic effects in the tissue context
  • Assess and predict drug response in patient tissues


  • Versatile: Track and measure localization of therapeutics: monoclonal antibodies, antibody-drug conjugates, bispecifics and recombinant proteins
  • Sensitive: Detect and quantify low expressing targets while maintaining tissue morphology
  • Predictive: Assess drug mechanism of action to build more reliable therapy response models
  • Accurate: Reduce detection of false negatives
  • Flexible: Compatible with typical FFPE IHC antibodies and multiplex staining methods in a single tissue section

Selected Publications

Poster Presentations

White Papers

Service Flyers

  • Download the Quanticell service flyer here!
  • Download the Quanticell low HER2 tissue testing flyer here!

Digital Biomarker Solutions

Invicro has established a strategic alliance with Paige, a leader in clinical-grade artificial intelligence (AI) for diagnostics, drug discovery and biomarker development applications. With this partnership, Invicro now provides biopharmaceutical clients access to world-class digital pathology solutions across a range of disease indications. The computational pathology solutions support efforts spanning from preclinical discovery studies to clinical trials and diagnostic product commercialization.

Paige has produced AI solutions that generalize and phenotype tissue specimens without the need for labor-intensive and subjective annotation-based methods. In addition, access to critical data, such as genomics, treatment information, drug response, and other clinical assessments is available to augment and gather insights from clinical studies. Through this partnership, we address core challenges including:

  • Lack of access to curated pathology datasets
  • Need for expertise in managing clinical studies
  • Access to regulatory expertise



Pharma Service Offerings

  • Custom Biomarker Discovery Studies
  • Multi-modality Studies
  • Clinical Product Development & Commercialization


  • Download the Digital Biomarker service flyer here!
  • Download our White Paper: Discovery of novel AI-based digital biomarkers for the development of personalized oncology therapies here!